Sr. Manager – Regulatory Affairs Strategy – Pharma
| Company | Alcon |
|---|---|
| Location | Fort Worth, TX, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
Requirements
- Bachelor’s Degree or Equivalent years of directly related experience (or high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
- The ability to fluently read, write, understand and communicate in English
- 7 Years of Relevant Experience
- 5 Years of Demonstrated Leadership
Responsibilities
- Directing submission development of product registration, progress reports, supplements, amendments, and/or periodic experience reports
- Providing strategic product direction to teams on interaction and negotiating evidence with regulatory agencies
- Interacting and negotiating with regulatory agency personnel in order to expedite approval of pending registration and answer any questions
- Serving as a regulatory liaison on the project team throughout the product lifecycle
- Participating in one or all of the following activities: development of product plan, regulatory strategy, risk management, implementation plan, chemistry manufacturing control (CMC)
- Ensuring pre-clinical and clinical trial designs meet regulatory requirements
- Ensuring rapid and timely approval of new drugs, biologics/biotechnology products and continued approved status of marketed drugs or medical devices
- Serving as regulatory representative to marketing or research project teams and government regulatory agencies
- Providing advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations
- Coordinating, reviewing and potentially preparing reports for submission
Preferred Qualifications
-
No preferred qualifications provided.