This client is a global leader in diagnostics and medical imaging which is dedicated to improving the lives of patients worldwide. They are seeking a Regulatory Affairs Manager who can lead regulatory strategies and submissions for a portfolio of drug, device, and diagnostic products. You will work closely with internal cross functional teams and the FDA to get products approved in the US. This company offers a competitive salary, comprehensive employee benefits, and a close-knit, collaborative environment. Now is an exciting time to join this dynamic organization!
Responsibilities:
- Develop and lead US regulatory strategies for drug, device, and diagnostic programs in various stages of development.
- Lead the preparation and submission of INDs, NDAs, 501(k)s and PMAs, etc. to the appropriate regulatory agencies for assigned projects.
- Serve as the primary liaison for FDA on assigned projects. Respond to regulatory agency contacts (telephone, written, meetings, etc.) to assure expedient and efficient review and approval of products.
- Ensure that all regulatory documents have been evaluated to assure that they are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance, and are presented in a way that facilitates agency review.
- Coordinate regulatory agency meeting activities including meeting requests, background packages, etc.
- Represent regulatory affairs on various cross-functional teams, including project teams, clinical development teams, manufacturing teams, etc.
- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
- Interpret regulatory rules or rule changes and ensure through training programs or other appropriate communication tools that they are understood and followed by everyone and included in updated corporate policies and procedures.
Knowledge and Skills:
- BA/BS degree in a scientific field; advanced degree preferred (MS, PharmD, PhD).
- At least five years of experience in regulatory affairs for diagnostics, novel pharmaceuticals and/or medical devices.
- Experience with preparing regulatory submissions including INDs, NDAs, 510(k)s, and/or PMAs.
- Demonstrated knowledge of drug development process including knowledge of FDA and ICH guidelines and regulations for pharmaceuticals.
- Knowledge of CTD and eCTD structure and excellent regulatory writing skills.
- Hands on experience with FDA interactions and understanding all processes associated with FDA interactions.
- Proven track record of project management skills.
- Excellent interpersonal skills, ability to manage conflicting points of view and negotiate an appropriate resolution to issues while ensuring compliance with applicable regulations.
- Good communication skills, both written and verbal.
- Must be able to convey scientific and sometimes complex issues in a clear concise manner to ensure understanding across a very diverse employee population.
- Must be a flexible, collaborative, team player, who is able to deal with ambiguity.