Senior Clinical Regulatory Affairs Manager – FILLED
The Wellington Group has been engaged to find an experienced Senior Clinical Regulatory Affairs Manager for a large, international pharmaceutical and biologics organization. This is a great career opportunity within a well established, profitable, global brand.
The RA Manger will prepare and facilitates meetings / teleconferences with regulatory agencies and advise team members on the applicability of new regulations and guidelines. Will be responsible for the maintenance of various clinical and nonclinical regulatory documents, including INDs/BLAs/NDAs and ensure that the elements, quality, accuracy and format of regulatory submissions comply with applicable laws, regulations and corporate standards.
Senior Clinical Regulatory Affairs Manager responsibilities include:
- Serves as the regulatory representative on various project subteams and addresses a broad range of problems of moderate scope
- Manage project plans and timelines for multiple projects
- Perform literature searches, prepare special reports and assemble documentation to support project teams
- Applies knowledge of FDA regulations and ICH guidelines to provide regulatory guidance and contribute to strategic planning on project teams
- Develop and maintain departmental processes, policies, SOPs and associated documents
- Lead or participate in department initiatives, task forces, and training
The qualified Senior Clinical Regulatory Affairs Manager candidate will have:
- Minimum of 5 years regulatory/clinical experience is required
- 4-year degree required, advanced degree preferred
- Knowledge of drug development regulations
Industry: Pharmaceuticals, Biologics, Clinical research Regulatory Affairs
Permanent position with an employee centered company offering great benefits, salary, bonus and relocation assistance.