Director, Global Regulatory Program Management
Proclinical is currently recruiting for a Director of Global Regulatory Program Management with a global biopharmaceutical company located in Arlington, VA. Successful candidate will be responsible for overseeing and managing relationships with all regulatory partners of the company (building and fulfilling regulatory agreements/ways of working with marketing partners, contractors, and consultants) and will ensure consistent planning, timeline development, and prioritization to provide RA support for the company launch and global supply delivery plans.
- Act as main point of contact to partner regulatory teams building agreements and ways of working; coordinate planning across all external partners and key internal stakeholders to deliver commitments.
- Develop a work planning process to track and prioritize regulatory resources to ensure timely RA support for project teams and to ensure regulatory freedom to operate for business goals.
- Manage regulatory input and support for global supply chain planning to enable timely product flow for launch and post approval. Enhance the regulatory risk management process.
- Serve as chief of staff for GRA, ensuring efficient disposition of routine department business including but not limited to recruiting, onboarding, budget management, contract oversight.
- Develop timeline frameworks for tracking and communication of key submission plans, and management of critical path activities.
- Implement continuous improvement process (health authority interactions and strategy, best practice development and sharing, regulatory learning and sharing community).
Skills and Requirements:
- BA or BS preferably in scientific area. PhD or equivalent is highly desirable as role involves interactions with technical information and experts.
- 9+ years in relevant functions in the Pharmaceutical Industry or biotech or equivalent.
- Subject matter expertise in program management and critical issue management.
- Six sigma certification strongly preferred.
- Previous experience in coordinating interactions between organizations and companies.
- Strong familiarity with biologics regulatory environment in US and EU; additional regions is a plus.
- Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment required. Will be expected to build team spirit, be tolerant and considerate, be an active and open communicator and share knowledge and experience with other team members.
- High level of communication skill in English, both written and verbal. Any additional language is beneficial.
If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at (+1) 646-367-2908 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.