Director, Regulatory Strategy - United States
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
- Develop and implement sound global regulatory strategies for multiple products.
- Lead the Global Regulatory Team; develop and maintain the Global Regulatory Strategy and Submission Plans
- Plan, coordinate, and prepare for meetings and teleconferences with regulatory agencies.
- Write paper and electronic submissions, as applicable, to support development project plans and timelines for IND, NDA, and MAA and related submissions, as well as amendments and supplements to these applications and responses to regulatory agency requests.
- Collaborate with responsible departments and lead preparation, review, and collection of documentation for regulatory submissions.
- Provide critical review of all documentation supporting regulatory applications.
- Collaborate with CROs or other partnering organizations and coordinate international submissions to meet regulatory requirements.
- Work with peers to develop standard operating procedures and departmental guidelines.
- Participate as a full member of the research and development team(s) for the company’s products.
- Develop and manage regulatory project specific timelines, in keeping with Corporate objectives and actively participates on project teams advising on submission preparation timelines, processes, and requirements.
- Review protocols, reports, and documents used in regulatory submissions.
- Mentor regulatory associates and managers.
- Assume other relevant assignments as directed by supervisor
- Bachelor’s degree in Biology or Chemistry, advanced degree preferred
- Minimum of 10 pharmaceutical industry experience
- 5 years of regulatory experience as global regulatory leader.
- Experience managing global CTA submissions
- Demonstrated evidence of writing regulatory documents including briefing packages
- Knowledge for FDA and ICH regulations a must
- Knowledge of drug development
- Strong verbal and written communication skills are essential.
- Excellent organization and multi-tasking skills.
- Exceptional interpersonal skills and problem solving capabilities.
- Proven negotiation skills.
- Ability to work effectively across a matrix organization.
- Ability to work independently and prioritize with minimal daily instruction.
- Ability to think strategically in order to improve current processes.