Senior Manager / Associate Director

Regulatory Affairs Manager

There is an Immediate opening for a Senior Regulatory Affairs Manager

Based out of the Boston, MA area. The right candidate should have extensive Regulatory Clinical Strategy experience, and should be excited about the prospect of joining a growing biotech company with 2+ drugs on the market as well as 6 different compounds in the IND phase. The right candidate should be able to clearly communicate and evaluate regulatory risks, and provide strategic guidance for product development.

You will be responsible for both premarket and postmarket strategy, and should really be a true RA generalist who is not alligned with one single therapeutic area or type of product.

-Minimum of BS degree in life sciences or related field, ideally an MS or advanced degree
-Minimum 10 years in pharmaceutical regulatory affairs, with an emphasis on submission strategy
-Review outgoing FDA correspondence (INDs, amendments, supplements) for completeness, correctness and compliance to FDA regulations and guidelines.
-Some experience interacting with foreign health authorities.
-Ability to negotiate response to FDA deficiencies
-Excellent oral and written communication skills

To find out more about Real Staffing please visit www.realstaffing.com