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Join a world leader in this very exciting and highly visible Sr Leadership role as an Associate Director Regulatory Affairs
This organiation is an international biopharmaceutical company identifying, developing and commercializing meaningful products that address unmet medical needs. They are continuing to expand their commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know us.
An Associate Director, Regulatory Affairs will be a key stakeholder in the company’s regulatory activities and initiatives to ensure the quality of the company’s records, products and processes. He/she will support our efforts to obtain worldwide approvals to market our products. An Associate Director, Regulatory Affairs within the Regulatory Strategy group will manage worldwide interactions and negotiations with regulatory agencies and marketing partners in support of investigational studies, product registrations, and commercial products. An Associate Director, Regulatory Affairs will be a key member of project teams and teams responsible for evaluation of product concepts.
This opportunity is available in both Palo Alto, CA and Philadelphia, PA
Essential Job Functions:
Job Responsibilities and Requirements:
- 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
endevis, LLC. and all companies represented are Equal Opportunity Employers and do not discriminate against any employee or applicant for employment because of age, race, color, sex, religion, national origin, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state or local protected class.IND-D08#LI-01
- Bachelors or Masters 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
- Some travel required