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Regulatory Affairs Manager

Job Attributes

Job Id:

32018

Job Category:

Clinical & Life Sciences

Job Location:

Devens, Massachusettes  

Security Clearance:

No Clearance

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions

JOB DESCRIPTION

Piper Companies is currently looking for an experienced Regulatory Affairs Manager in Devens (MA) to work for an innovative and growing pharmaceutical manufacturer. The Regulatory Affairs Manager will play in pivotal role in the development and manufacturing of pharmaceutical drugs

Responsibilities for the Regulatory Affairs Manager include:

·      Act as SME for all regulatory matters regarding design, development, validation, commercialization of pharmaceutical drugs  

·      Act as liaison with regulatory agencies and the facility in all matters of regulatory submissions

·      Develop, review and revise SOP’s that will ensure regulatory compliance

·      Oversee regulatory personnel as a coach, mentor and trainer

·      Maintain knowledge of relevant guidelines including proposed and final regulations

Qualifications for the Regulatory Affairs Manager include:

·      BS or higher degree in chemistry or regulatory affairs   

·      5-10 years of experience in the pharmaceutical manufacturing industry

·      3-5 years of experience within regulatory affairs leadership

Compensation for the Regulatory Affairs Manager include:

  • Salary Range is dependent upon experience
  • Comprehensive benefits package, including Pension and 401k


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New Search

Job Id:

32018

Job Category:

Clinical & Life Sciences

Job Location:

Devens, Massachusettes  

Security Clearance:

No Clearance

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions