7 months ago
Job Title: Manager/Senior Manager, Regulatory Affairs
Job Location: United States, (Homebased)
Job Duties and Responsibilities:
- Provide regulatory guidance internally to project teams, functional areas and externally to clients.
- Develop client regulatory plans including timelines, submission documentation, communication, and reporting and tracking of regulatory deliverables.
- Maintain and develop regional and/or global strategic plans for the development of client drug product.
- Prepare technical content for and review of regulatory documentation and submissions.
- Liaise with regulatory authorities, clients, contractors, consultants and vendors.
- Identify where regulatory specialty expertise is required or regions where local regulatory submission expertise is needed to meet project requirements.
- Maintain effective internal and client project team communication to ensure quality, timeliness and within budget delivery of regulatory tasks.
- Participate in internal and client project team meetings.
- Participate in meetings with regulatory authorities.
Education and Experience
- Bachelors’ degree in area of concentration commensurate with responsibility. Post-graduate degree and leadership role in academia or in pharmaceutical industry highly desirable.
- 4+ years’ work experience commensurate with functional area of responsibility; or combination of work experience, education or other related industry experience in similar role.
- Experience working in clinical research organizations is highly desirable