Register
Recruit Create CV

Director Of Regulatory Affairs Jobs in Arkansas

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
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.
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.

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