For The Candidates

(973) Area code              N NJ

Regulatory Affairs Associate Director - Program
 

Position:

1. Provides regulatory strategy and tactical support to the regulatory leader of a global team or US product team and/or US regulatory lead on projects of moderate to complex  levels and/or discrete components (line extensions, new indications) of larger projects of moderate to complex levels
2.  Serves as principal interface with primary reviewers from health authorities (e.g., FDA)
3. Develops regulatory strategy and 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 lesser 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 – PhD PharmD preferred
2.  6+  years relevant experience in regulatory affairs or drug development
3. Basic working knowledge of core processes:  discovery, development, manufacturing, and marketing
4. Demonstrated leadership skills
5. Communication and organizational skills
6. Demonstrated team and interpersonal skills
7. Commitment to performance measures of time, costs, and quality