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Director Of Regulatory Affairs Jobs in Washington, Arkansas

Manager Of Regulatory Affairs
By Connect Life Sciences At Washington DC-Baltimore Area, United States
Strong management and leadership skills; experience leading/managing a team/project and/or supervising staff preferred.
Works closely with project management to mitigate/resolve issues and/or deviations from target timelines.
Provides regulatory and project management support for projects as needed.
Superior organizational skills and customer service abilities.
Strong working knowledge of Microsoft office; experience with SharePoint a plus.
Supervises and manage Regulatory Team staff members, as assigned.
Associate Director Of Regulatory Services
By Synterex At United States
Strong interpersonal and leadership skills to influence without authority, motivate others, and manage conflicts
The position will be responsible for the management and oversight of the following areas:
Grow the regulatory intelligence capabilities within the organization
BS degree in a scientific field, with 8 years of experience in a biotechnology or pharmaceutical setting; Advanced degree preferred.
Excellent written and verbal communication skills
Excellent word processing, SharePoint, Excel, E-mail and online meeting tool skills
Director Regulatory Affairs Jobs
By Altasciences At United States
Critical thinking skills and ability to acquire and apply knowledge quickly;
Lead, manage and prepare clinical trial submissions;
Lead, manage, prepare, and submit meeting requests and meeting information packages to health agencies;
Lead, manage, prepare, and submit controlled correspondence to regulatory agencies;
8+ years of regulatory experience in an industry setting;
Strong knowledge of drug development and regulatory policy;
Client Services Director Regulatory Affairs- Boldapprovals (East Coast)
By BOLDSCIENCE At United States
Experienced financial management including budgets, forecasting, recoverability
Experience managing a variety of medical communications tactics
Manages resourcing needs across the team in conjunction with the VPs
Manages and inputs into the career development of direct reports and their teams, closely reviewing goals and objectives
Line manages multiple team members of varying levels, providing constructive and actionable feedback to team members
Extensive experience working within regulatory affairs and/or the medical communications industry
Director/Senior Director Regulatory Affairs
By RBW Consulting At United States
7-10+ years Regulatory Affairs experience
Experience in development and commercial product lifecycle (Phases 1-3, Marketed Products)
Relevant experience with regulatory applications (IND / CTA / NDA / MAA etc.)
Success in filing IND's/CTA's in Oncology
Educated (MSc, PhD, or PharmD) in the Life Science, Pharmacy or similar field.
Direct exposure to FDA/EMA etc. Interactions
Director Of Regulatory Affairs
By Lumicity At United States
Experience with documentation and lifecycle management within the biotechnology industry preferred
Effectively communicate the regulatory strategy, risks mitigation, and overall plans to program teams and senior management
Knowledge of regulatory requirements across development stages
Manage filings of necessary regulatory documents and manage lead meetings with regulatory agencies and other reviewing bodies
Identify applicable regulatory requirements for conducting clinical trials
Manage and help negotiate the regulatory activities of contract research organizations, consultants, and contractors in the preparation of regulatory submissions
Director Regulatory Strategist Jobs
By Viatris At United States
Extensive knowledge of the regulatory environment and ability to leverage this to impact regulatory strategy development and implementation
Knowledge of assigned therapeutic areas/disease areas is preferred
Regulatory Affairs Professional Certification preferred
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Associate Director/Director Regulatory Cmc
By TG Therapeutics, Inc. At United States
Maintains current knowledge of regulations and guidelines (FDA, ICH, and others as required).
5-10 years experience in regulatory CMC
Coordinate and lead the task of drafting responses to CMC-related questions from FDA or foreign health authorities.
Work with functional groups to provide timely responses to CMC questions from regulatory authorities.
Coordinates activities for meetings with FDA and other regulatory authorities.
Coordinates with cross-functional teams to define contributions to submissions.
Director Of Regulatory Affairs - East
By Carter Maddox At United States
In coordination with functional groups, manage policy and filing priorities.
Able to manage consultants to assist where necessary.
Experience in the renewable energy sector.
Strong experience in the regulatory process at state and federal level with a proven track record.
Exceptional analytical skills in understanding policy impacts to energy development and pricing.
Advanced level of education in policy is preferred but not required.
Associate Director Regulatory Affairs
By GQR Global Markets At United States
Manage submission plans and timelines to ensure approvals are timely and development objectives are met .
Manage regulatory data and information within systems .
Strong scientific background with at least five (5) years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries.
Proven ability to successfully manage major submissions and critical projects to deadlines.
Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects).
Represent and coordinate regulatory information as a team member, covering clinical, non-clinical, CMC, labeling, and post-approval change activities .
Director, Regulatory Affairs Cmc
By Agenus At United States
Participates with senior management to establish strategic plans and objectives.
Interacts with senior management, executives, and/or major customers which frequently involves negotiating matters of significance to the organization.
Directs the activities of a functional area or multiple integrated departments through lower management.
Ensures budgets and schedules meet corporate requirements.
Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:
Makes final decisions on implementation and ensures operational effectiveness.
Sr Director Regulatory Affairs Cmc
By Discover International At United States
Extensive knowledge of global regulatory requirements and guidelines for CMC in drug development.
Provide strategic guidance on CMC requirements for drug development programs.
Strong leadership skills, with a track record of managing high-performing teams.
Excellent communication and interpersonal skills for effective collaboration.
Strong problem-solving and strategic thinking abilities.
Develop and implement global regulatory CMC strategies aligned with corporate objectives.
Vice President Of Regulatory Affairs
By Charlton Morris At United States
5+ years’ medical device Regulatory Affairs experience with ophthalmic devices.
Proven success in a Regulatory leadership position (Senior Manager’s & Manager’s will be considered)
Experience working internationally and available to travel
Proven track record with PMA, 510(k), EUMDR, FDA.
Educated to Bachelor’s degree level in a related discipline.
Be instrumental in launching a disruptive device that will create a new gold standard in patient care
Vice President Of Regulatory Affairs
By Barrington James At United States
Experience in the full-life cycle management of Regulatory submissions (small molecule)
12+ years experience in Regulatory Affairs
Experience with commercial launch of a product and in leading commercial stage product regulatory activities
Experience in a small or start-up organization (preferred)
Experience managing and collaborating with outside partners/vendors (preferred)
Vice President of Regulatory Affairs - Remote
Senior Director Regulatory Affairs
By Tigermed At United States
Have full knowledge of regulations in US FDA.
Experienced in meeting with, making presentations to, and negotiating with regulators, including complex or sensitive issues.
Ability to independently manage and monitor multiple projects without direct supervision.
To participate or lead regulatory project related to US FDA filing.
Contribute to the development of regulatory strategy for specific projects, including identifying and assessing regulatory risks.
Responsible for establishing and maintenance of standard operation procedure and other related working standard for US FDA filing.
Director Of Regulatory Affairs
By Trebla Talent At Greater Chicago Area, United States
Strong knowledge of current drug development regulations and guidelines including ICH, FDA and EMA guidelines; NDA experience is required.
Minimum of 10 years of experience across Regulatory Affairs or another transferrable function in biotech/pharma
Both clinical and CMC experience is desired
Bachelor’s degree is required; advanced degree is preferred.
A passion for the psychedelic and mental health industry
Director/Senior Director of Regulatory Affairs
Director Of Regulatory Communications
By Philip Morris International At Washington, DC, United States
Manage and supervise the Regulatory Communications team, providing clarity of roles and responsibilities as well as growth, development and engagement opportunities
Initiate analyses of special situations that might impact PMI; develop and execute proactive/reactive plans for crisis management under
10-15 years or equivalent mix of education and experience in Corporate or Government Communications
Create, manage and measure the impact of communications campaigns targeting regulators and activists, in line with External Affairs
Execute rapid response communications strategies, adjusting priorities to manage new and emerging special situations external to the organization
Manage vendors on local assignments
Assistant Director Of Regulatory Affairs
By NC Real Estate Commission At West Bend, NC, United States

Attorney needed to assist division director with supervisory and managerial responsibilities and to prosecute cases involving allegations of violations of Real Estate License Law and Commission ...

Director Or Sr Director Regulatory Affairs - East Coast Remote Flex
By GQR Global Markets At Massachusetts, United States
Manage third party vendor partner performance and workload to support regulatory operations and regulatory publishing.
Manage regulatory budgets, resources, and timelines to optimize operational efficiency and meet business objectives.
Experience in managing regulatory inspections, audits, and interactions with regulatory agencies including direct contact with regulatory agencies.
Final accountability for regulatory documentation, ensuring adherence to FDA and other health authority specifications and timelines
Preference for East Coast-based candidates.
Director Of Quality And Regulatory Affairs; Full Time; Days
By Mount Sinai At , New York, 10029 $140,000 - $230,584 a year
Responsible for supporting the management of an operating budget for the department.
Maintains current knowledge of quality improvement information, patient safety, and regulatory requirements.
Coordinates all documentation requirements for the Performance Improvement and National Patient Safety Goal chapters of The Joint Commission manual.
Supports the coordination and direction all activities to ensure the effective implementation of the Quality Improvement Plan.
Designs, develops, implements and evaluates quality improvement policies and procedures.
Develops and facilitates the use of data collection tools to support data analysis.
Director Of Regulatory Affairs
By Tabseer | تبصير At Dallas, TX, United States
-Thorough knowledge of relevant regulatory laws, guidelines, and industry standards in Products Certification and Inspection Activities.
-Excellent communication and negotiation skills to articulate regulatory requirements and advocate on behalf of Tabseer.
-Good relationship with top level of Saudi Regulators’ Management Team.
Job Title: Regulatory Affairs Manager
-Clarify any ambiguous regulatory points or requirements by engaging with regulators and coordinating with internal teams.
-Stay informed about changes in regulatory landscape and assess their impact on Tabseer's certification and inspection operations.
Senior Director Of Quality And Regulatory Affairs
By Goodall Brazier At Texas, United States
12+ years related GMP experience in biotechnology, chemistry, biochemistry, microbiology, pharmaceutical, manufacturing, or laboratory environment. 7-10 years experience in Quality Management.
Expert knowledge of GMP, FDA, and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products
Regulatory Knowledge CBER, CDER, CDRH, and other global agencies
Experience interacting with FDA and other global agencies
Ability to prepare audit reports, quality agreements, standard operating procedures, and CAPA reports in accordance with companies Quality System requirements
Experience leading a Quality Dept at a CDMO (preferred)
Director Of Regulatory Affairs
By Sterling-Hoffman Life Sciences At Richardson, TX, United States
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the nutraceuticals industry is strongly preferred
4) Preference will be given to candidates with recent experience in regulatory affairs
4) Help the Regulatory Affairs Team apply complex regulatory concepts to projects in an easy-to-understand manner
5) Understand the interrelationship between labeling, artwork, and product regulations
8) Maintain regulatory records and files
Director Of Regulatory Affairs
By Hemab Therapeutics At Boston, MA, United States
Direct point of contact with health authorities, leads and manages Regulatory Agency meetings, in cooperation with outsourced vendors.
Bachelors degree in a scientific subject area coupled with sufficient industry experience. Advanced degree (e.g. MSc, PhD, PharmD, MD) preferred.
Keeps abreast of new developments and therapeutic innovations, including regulatory requirements related to gene therapy and associated science.
Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability.
Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
Participates with influence in or leads departmental and cross-functional taskforces and initiatives.
Senior Manager / Director, Regulatory Affairs
By X4 Life Sciences At Bucks County, PA, United States
Knowledge & Experience of compiling CMC sections of ANDAs & NDAs (eCTD), reviewing DMFs
Title: Senior Manager, Regulatory Affairs OR Director, Regulatory Affairs
$140k-$220k + benefits + bonus
10+ years' RA experience within pharmaceutical manufacturing
Working knowledge of FDA regulations (e.g., 21 CFR 314.50 and 314.94 and 21 CFR 201 and 208) and applicable FDA guidance
Experience working with & overseeing external resources (e.g., CROs, CMOs) and a team of direct reports
Senior Director, Regulatory Affairs
By Relay Therapeutics At Cambridge, MA, United States

You have earned your B.S and/or M.S. and bring 10+ years of relevant work experience in pharmaceutical regulatory affairs.

You have a "can do" attitude, and you are passionate about the impact of regulatory work on patients.

Head Of Regulatory Affairs
By Life Science People At Torrance, CA, United States
Proven people management experience, with a track record of building and leading high-performing teams
Participate in the development and implementation of regulatory strategies to support product approvals, license maintenance, and lifecycle management
Collaborate with cross-functional teams to ensure that regulatory requirements are integrated into product development plans and timelines
Strong knowledge of FDA, EMA, and other global agencies' regulations related to CMC submissions for generics and NCEs
Excellent writing, communication, and interpersonal skills
Prepare and maintain CMC documentation for various applications, including NDAs, DMFs, CEPs, INDs, etc.
Senior Director Regulatory Affairs
By Experian At Washington, DC, United States
Excellent communication, organization, and time management skills.
Minimum 5-10 years of experience either on Capitol Hill, at state or federal financial regulatory body, or with a policy-oriented organization.
Experience working on financial services, technology, and privacy policy issues preferred.
Excellent interpersonal skills with the ability to work with diverse personality types and across party lines.
Excellent writing and communications skills are essential.
Competitive pay and comprehensive benefits package, with a bonus target of 20%
Director Of Regulatory Affairs (Cell Therapy)
By GQR Global Markets At San Francisco Bay Area, United States
Assist in organization and management of staff within the RA group, including coaching, career development and oversight of work, as required.
Depth Knowledge of GLP and GCP regulatory requirements in domestic and globally.
Manage all aspects of nonclinical and clinical regulatory strategy development for products (early- to late-stage/registration/post-market).
Prior experience with cell or gene therapies (preferred)
Prior experience in oncology drug development
10+ years working within the biotech/pharmaceutical industry. 8+ years of pharma and/or biotech regulatory CMC-experience.
Research Director/Regulatory Affairs Mngr
By Napa Research Center At Pompano Beach, FL, United States

Opportunity to advance career in clinical research company. Great financial compensation plan with healthcare benefits. Overlook responsibility of a great dedicated staff and be an integral part in ...

Director Of Compliance & Regulatory Affairs (Remote - United States)
By Season Health At Austin, TX, United States
Develop, build, manage and oversee the organization’s compliance program, aligned to CMS/HHS guidance, and privacy program
Develop internal guidelines, toolkits, and packaged knowledge for the business on relevant regulatory & compliance issues
Significant prior experience managing a compliance program aligned to CMS/HHS guidelines is required
Prior experience directly advising Product and Marketing teams strongly preferred
This is a remote role, but you must reside in the US
Exceptional written and verbal communication skills, understanding your audience and calibrating your messaging appropriately
Director- Iso Regulatory Affairs
By Jupiter Power At Austin, TX, United States
5-7 years of experience in regulatory affairs, policy, trade compliance, strategy or business development in the power market industry
Experience in PJM, MISO or NYISO power markets
Experience in managing external consultants and deriving/approving external scopes of work
Experience representing power generation in ISO/RTOs
Extensive work experience beyond the 5-year minimum.
Lead ISO/RTO Regulatory Affairs Activities for FERC jurisdictional electricity markets, including formulation of internal policy goals and external representation
Chief Of Regulatory Affairs
By Idea Evolver At Philadelphia, PA, United States
10+ years of experience in Regulatory and Quality management, preferably in the SaMD space. ACNU expertise is a huge bonus.
Overseeing CAPA, Change Management, Internal and External Audits, Management Review & Post-Market Surveillance needs.
Overseeing QA/RA team to provide support for ensuring company compliance with all applicable quality, regulatory, & statutory requirements.
Responsible for ensuring compliance to Design Control & SDLC process requirements at a project level.
Experience working with medium to large-sized businesses in a client-facing role.
Highly motivated, independent individual with strong organizational skills and a thorough attention to detail.
Associate Director, Regulatory Affairs, Supply Chain
By Avanos Medical At California, United States
Provide leadership to maintain compliance with domestic and international regulations as well as management of the Avanos Mexico facilities’ State Licenses.
Continue to increase education/knowledge in the area of Regulatory Affairs.
Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;
Eight to ten years experience in Regulatory Affairs.
Exceptional written and verbal communication skills.
Team player with excellent organizational skills.

Are you looking for an opportunity to make a real impact in the healthcare industry? We are looking for a Director of Regulatory Affairs to join our team and lead our regulatory strategy. You will be responsible for developing and implementing regulatory strategies to ensure compliance with applicable laws and regulations. You will also be responsible for managing the regulatory process, including preparing and submitting regulatory documents, and providing guidance to internal and external stakeholders. If you are a strategic thinker with a passion for regulatory affairs, this is the perfect job for you!

Overview The Director of Regulatory Affairs is responsible for ensuring that the organization is compliant with all applicable laws and regulations. This includes developing and implementing strategies to ensure compliance, managing regulatory filings, and providing guidance on regulatory matters. Detailed Job Description The Director of Regulatory Affairs is responsible for developing and implementing strategies to ensure compliance with all applicable laws and regulations. This includes researching and analyzing laws and regulations, preparing and submitting regulatory filings, and providing guidance on regulatory matters. The Director will also be responsible for developing and maintaining relationships with regulatory agencies, monitoring changes in regulations, and providing training and guidance to staff on regulatory matters. Job Skills Required
• Knowledge of applicable laws and regulations
• Excellent communication and interpersonal skills
• Ability to research and analyze laws and regulations
• Ability to develop and implement strategies to ensure compliance
• Ability to develop and maintain relationships with regulatory agencies
• Ability to provide training and guidance to staff
• Ability to monitor changes in regulations
Job Qualifications
• Bachelor’s degree in a related field
• 5+ years of experience in regulatory affairs
• Knowledge of applicable laws and regulations
• Experience in developing and implementing strategies to ensure compliance
• Experience in developing and maintaining relationships with regulatory agencies
• Experience in providing training and guidance to staff
• Experience in monitoring changes in regulations
Job Knowledge
• Knowledge of applicable laws and regulations
• Knowledge of regulatory filing requirements
• Knowledge of regulatory agency requirements
• Knowledge of strategies to ensure compliance
• Knowledge of developing and maintaining relationships with regulatory agencies
• Knowledge of providing training and guidance to staff
• Knowledge of monitoring changes in regulations
Job Experience
• 5+ years of experience in regulatory affairs
• Experience in developing and implementing strategies to ensure compliance
• Experience in developing and maintaining relationships with regulatory agencies
• Experience in providing training and guidance to staff
• Experience in monitoring changes in regulations
Job Responsibilities
• Develop and implement strategies to ensure compliance with all applicable laws and regulations
• Research and analyze laws and regulations
• Prepare and submit regulatory filings
• Develop and maintain relationships with regulatory agencies
• Monitor changes in regulations
• Provide training and guidance to staff on regulatory matters