Associate Director, Regulatory Affairs
Proclinical is currently recruiting for an Associate Director of Regulatory Affairs with a global pharmaceutical company located in Palo Alto, CA and Philadelphia, PA. As the Regulatory Affairs Associate Director, you will manage worldwide interactions and negotiations with regulatory agencies and marketing partners in support of investigational studies, product registrations, and commercial products.
- Develop and implement regulatory strategies to facilitate the progress of programs in all phases of development.
- Serve as the Regulatory Affairs representative on project teams; assure the progress of projects by providing direction, solutions and feedback to the teams.
- Lead regulatory interactions with health authorities, marketing partners, and vendors for their products/projects.
- Support the company's commercial products.
- Review and approve labeling for the company's products.
- Ensure the timely submission of INDs, NDAs, amendments, and supplements for their products/projects.
- Maintain awareness of and communicate changing regulatory agency requirements; provide training and regulatory intelligence to the organization.
Skills and Requirements:
- Bachelor's or Master's or advanced degree in a scientific discipline, with a minimum of 8 years in roles of increasingly responsibility in regulatory affairs or related areas in pharmaceutical drug development.
- Deep and broad knowledge of regulatory affairs; direct experience with pharmaceutical regulatory submissions and product approvals.
- Proven track record of effective collaboration with regulatory agencies, including the FDA.
- Demonstrated leadership success in management of regulatory activities.
- Excellent verbal and written communication skills.
- Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions.
- Ability to work with limited supervision, to set priorities to meet timelines and to motivate and influence others.
If you are having difficulty in applying or if you have any questions, please contact Funmi Gbadamosi at (+1) 424-361-3900 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.