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Director Of Regulatory Affairs Jobs

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%
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 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.
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.
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.
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.
Sr. Director Of Regulatory Affairs
By Simply Biotech At North Carolina, United States
10+ years of management experience in Regulatory with direct reports.
Responsible for the preparation and management of IND, BLA, 510(k) and/or other appropriate market authorization applications for existing and new products
Knowledge of FDA, Health Canada (HC) and United States Department of Agriculture (USDA) guidelines and requirements
5+ years of Pharmaceutical Industry Experience
Experience submitting to the FDA, HC, and USDA
Experience reviewing, revising, and authoring INDs, BLAs, and 510(k)s
Head Of Regulatory Affairs - Igt-D
By Philips At , San Diego, Ca
Extensive experience and knowledge required of global medical device regulations, requirements, and standards;
Leading strategic AOP management to optimize revenue
10 years of people management – with a strong track-record in successfully leading a Regulatory Affairs team
Experienced in strategic relationships with external stakeholders (e.g. Notified Bodies, FDA, Competent Authorities);
*Montana employees are currently excluded from this requirement at this time.
In return, we offer you
Head Of Regulatory Affairs
By Albion Rye Associates At Boston, MA, United States
Education, Qualifications, Skills & Experience:
Knowledge of Regulatory Affairs, working with products in early and late stages of clinical development
Experience working within Regulatory Affairs on a global level
Lead cross-functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.
Lead a Global Regulatory Team
Deliver regulatory milestones on your team including an assessment of risks and mitigation, emerging data, and the probability of success.
Director, Global Regulatory Affairs
By NextPoint Therapeutics, Inc. At Cambridge, MA, United States
Experience managing annual reports, IND amendments, IB updates, DSURs for lifecycle management of our pipeline programs.
Lead and manage all interactions/meetings with FDA and other health authorities.
Lead and manage preparation and submission of all regulatory documents across clinical and pre-clinical programs, including authoring where necessary.
Experience with oncology drug development required, experience in immuno-oncology drug development strongly preferred.
Experience with filing INDs required. Experience with direct interactions with FDA required.
Experience with biomarker strategies preferred, experience with companion diagnostic development a plus.
Assoc. Director / Director, Global Regulatory Affairs
By AVROBIO At , Remote
Experience interacting with the FDA and ex-US health authorities and current knowledge of global regulations, and guidance’s/guidelines
Experience in the development and preparation of successful regulatory strategies
Cell and gene therapy and/or rare disease experience preferred
Demonstrated matrix leadership skills and the ability to work effectively in a matrix team across multiple disciplines
Develop and implement global regulatory strategies including timings for regulatory interactions, pediatric development, orphan drug designations and routes to approval
Highlight and mitigate potential risks to timelines and deliverables
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
Director Of Regulatory Affairs
By Dive Staffing Services At Newtown, PA, United States
Knowledge/Experience of Chemistry, Manufacturing and Control sections of original Abbreviated New Drug Applications (ANDA), amendments, supplements, and annual reports.
Knowledge/Experience of Chemistry, Manufacturing and Control sections of New Drug Applications (NDA), amendments, supplements, and annual reports.
Strong knowledge of United States of Pharmacopoeia.
Expert knowledge of Title 21 of Code of Federal Regulations, various US FDA guidance
documents adhere to FDA eCTD requirements and company SOPs.
Review of Drug Master Files (DMF), amendments, supplements and annual reports.
Executive Director, Regulatory Affairs Strategy
By Neurocrine Biosciences At San Diego, CA, United States
Provides strategic guidance on global regulatory requirements to management and project teams
Detailed knowledge of FDA/EMA/ICH regulations and guidance for global drug development, preparation and management of IND/CTA/MAA/BLA/NDA applications
Regulatory experience and detailed knowledge outside the US (Japan and/or EU) is preferred
Manages preparation of all regulatory submissions (IND/CTA/MAA/BLA/NDA)
Master's degree preferred and 15+ years of related experience, OR
PhD and 12+ years of related experience OR
Director, Administrative And Regulatory Affairs
By GalenusRx At Florida, United States
An equivalent combination of education, training and experience that presents the required knowledge, skills, and abilities will be considered.
Experience with administrative laws, regulations, standards, and guidance for people management.
At least five years in leadership and management required.
Maintains knowledge of all applicable international regulation and regulatory guidance, as well as in-depth product knowledge and clinical / medical knowledge.
Obtain necessary approvals from regulatory agencies and bodies, and tracks and manages all proposal/reporting deadlines, submissions, and status updates.
Excellent written and verbal communication 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