Regulatory Affairs Sr Manager – Program

Position:

1. Provides US regulatory strategic direction as US regulatory lead of global teams and US product teams for projects of moderate complexity and/or discrete components (i.e., line extensions, new indications) of larger projects of moderate complexity
2.  Serves as principal interface with primary reviewers from health authorities (e.g., FDA).
3. Develops regulatory strategies, provides direction on health authority interactions, prepares regulatory submissions and demonstrates leadership on the team and within the function to accomplish business objectives.
4. Coordinates activities of small groups of local PDR personnel to ensure that tasks are completed within defined due dates and meet regulatory and departmental guidelines.
5. Manages special regulatory projects of moderate complexity, as assigned by others.

We are looking for:

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.

1. Bachelors Degree or equivalent
2. 3-5 years relevant experience in drug development including relevant experience in regulatory affairs
3. Basic working knowledge of core processes: discovery, development, manufacturing, and marketing
4. Demonstrated leadership skills
5. Communication and organizational skills
6. Excellent team and interpersonal skills