Global Regulatory Leader
Proclinical is currently recruiting for a Global Regulatory Leader with a global biopharmaceutical company located in Arlington, VA. As the Global Regulatory leader, you will support development across all products and at all stages of development, advising program teams, shaping regulatory strategy, leading market authorization filings and registration efforts, and representing the company with agencies and partners worldwide.
- Act as main point of contact for regulatory related discussions/input (both internally and with external stakeholders) for his/her assigned project(s).
- Develop Regulatory Strategy for assigned project(s) including authority interactions,
- Manage, in line with company's procedures and in collaboration with the project team, the preparation, compilation (including writing as necessary), assembly, review and filling (as appropriate) of regulatory documents in relationship with the drug development process.
- Manage, in line with company's procedures and in collaboration with the project team, the timely response to health authority queries.
- Coordinate and review of quality, non-clinical and clinical sections of regulatory dossiers.
- Maintain existing clinical trial authorizations, i.e. preparation of amendments and End of trial notifications in collaboration with CRO.
- Develop regulatory strategies.
- Input in decision process regarding clinical trial conduct and strategy.
- Supervise regulatory CRO counterparts as applicable
- Support development of standard processes, planning and resource management.
- Support the VP Regulatory Affairs activities when necessary.
Skills and Requirements:
- MS or equivalent, PharmD or PhD or equivalent desired.
- 7+ years in relevant functions in the Pharmaceutical Industry, or equivalent. Direct experience with biosimilars is an asset.
- Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment required.
- Significant subject matter expertise in regulatory affairs and related activities.
- Previous experience in coordination of interactions with health authorities and conducting clinical trials in Europe/US is necessary, along with a working knowledge of the EMA/FDA regulatory environment.
If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at (+1) 646-367-2908 or email@example.com.
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.