Sr Associate Of Regulatory Affairs

Description

Senior Regulatory Affairs Specialist

This highly-regarded orphan drug company in the San Francisco Bay Area is seeking to take on a permanent member of their Regulatory Affairs team. The right candidate will need to hit the ground running in order to be a productive member of the team, and to assist with the NDA application. If you are interested in entering the competitive realm of fibrosis and meet the requirements below, please apply.

Responsibilities:

- Reporting to the Director of Regulatory Affairs

- Assisting in filing US NDA and gain experience in emerging markets

- Routine regulatory submissions (including refilling and completing documentation for parent company)

- Involved in planning and executing regulatory strategy

Requirements:

- BA/BS in related science field

- 2+ years in clinical/developmental regulatory affairs

- Recent experience filing IND or NDA

- Excellent written and oral communication skills

If you are a passionate and driven candidate wanting to move up in regulatory affairs, this could be a great opportunity for you.