Job Summary
A biopharmaceutical company is searching for a person to fill their position for a Remote CMC Regulatory Affairs Director.
Individual must be able to fulfill the following responsibilities:
- Develop regulatory strategic plans in conjunction with project teams
- Lead the planning and preparation of formal meetings with regulatory agencies
- Assure compliance with project team timelines and milestones
Skills and Requirements Include:
- 9-14+ years of relevant experience and has earned a BS or equivalent degree
- 4+ years of experience leading teams and/or managing people
- Experience in eCTD format and structure
- Strong project management skills
- Demonstrated excellence in regulatory liaison/strategy
- Can prioritize deadlines, projects, and adapt to quickly changing environment
