Director, Regulatory Affairs Jobs

Provides oversight, interpretation, support, training, and key input to staff on interpretation of regulatory strategies, GXP regulations, regulatory guidelines, corporate standards, and policies...

Develop and implement strategies and regulatory submissions for PIP, OD, SME, MAA and post-licensing activities as applicable.

Serve as a resource for SRS team members and ICON colleagues, providing advice on project and Regulatory strategies.

Identify relevant and emergent guidance documents, international standards, or consensus standards; provide interpretive guidance and ensure guidance is implemented into development planning and execu...

Searching for a Regulatory Affairs.

Manage worldwide submissions for new products and product changes as required to ensure timely approval for clinical studies and market release. Review significant regulatory strategies with leadershi...

Leads the development and implementation of regulatory strategy and activities. Represents RA in product development project teams advising on timelines, regulations, process, and requirements...

Strategic thinking, leadership skills, assertiveness, strong technical background, and excellent negotiation and project management skills as evidenced by past performance as regulatory lead on global...

Work directly with Director of Regulatory Affairs, Global Head of Regulatory Affairs, Director of Clinical Monitoring, EVP, Clinical Operations, Project Managers and Clinical Trial Managers in execut...

Preparation, review, revision, and finalization of appropriate scientific and regulatory documents associated with pre-approval pipeline and commercial products in compliance with all appropriate regu...

Developing and maintaining quality and regulatory systems and system elements in conformity with domestic and international medical device agency regulations and requirements. System elements include...

Guide company’s navigation of international regulatory pathways, and ascertain organizational compliance with other regulatory requirements such as HIPAA...

As the Director of Regulatory Affairs, you will assume the lead on regulations, including both state and federal regulations for all products and support the Canadian Coty business across divisions...

Developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy...

Provide clients with strategic advice in response to their queries, based on regulatory experience and expertise in at least one CMC discipline.

Perform and/or oversee planning, authoring, preparation, and submission of regulatory documentation to appropriate regulatory authorities (as needed). Coordinate and consult with other departments on...

Responsible for developing international regulatory strategies across portfolio of medicines.

Provide educational training for local regulatory staff, sales teams, contractors, and others regarding company policies and procedures within the scope of the Regulatory Affairs...

Provide expertise in the interpretation of regulations and guidance relating to product development and other regulatory requirements. Coordinate with European/ROW Regulatory Affairs group for global...

Lead a team of global regulatory professionals for strategy on development and marketed products.

Ensure compliance with regulatory procedures and work practices; support processes by which regulatory submissions are reviewed, finalized, and signed-off. Provide interpretation of regulatory author...

Represent the regulatory function on cross-functional development teams. Provide regulatory guidance and strategy including identifying and assessing regulatory risks...

Coordinate (for one or more specific sections) the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities...

Prepare timely and compliant submissions to domestic and international regulatory agencies (510(k), IDE, PMA, HDE, IND, BLA, CE dossiers, supplements, responses, state licensure/certifications, export...

We are on a critical mission to bring quality solutions to patients at a fraction of the price. This role will help us drive forward towards that pinnacle goal of truly putting patients first...