The Wellington Group is seeking an experienced Regulatory Affairs professional for an international leader in biotechnology innovation. Come work for one of the top ranked employers in the pharmaceutical industry.

The Regulatory Affairs Manager will be responsible for the development and implementation of regulatory strategies to facilitate the development and ultimately, approval of drugs/biologics for human use. Will serves as the primary liaison with regulatory authorities and manages the strategy and execution of these interactions.

Responsibilities Include:

• Serves as the regulatory representative on a minimum of one project and represents a complete regulatory strategy, including CMC and Commercial
• Presents regulatory strategies and issues to corporate committees/senior management
• Serves as the primary liaison with regulatory authorities
• Lead cross-functional teams in the coordination of regulatory submissions
• Leads and participates in department initiatives, task forces, and training
• Provide leadership in researching, recommending and implementing new processes in the department/company
• Continue to expand knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics

Qualified Candidates will have:

• At least 5-7 years of experience in regulatory affairs for drug development
• BS degree required, MS or PhD preferred
• Demonstrate leadership, sound decision making, negotiation and problem solving skills in an independent manner

Industry: Pharmaceutical, Biologics, Medical Device

Job Code: BHJOB1778_175

Permanent position with an employee centered and owned company offering great benefits, salary, bonus and relocation assistance.

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

http://www.twgrecruiters.com