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Manager, Regulatory Affairs (CMC)

Norwood, MA 02062

Posted: 04/10/2019 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2311

The Manager, Regulatory Affairs (CMC) will lead in the planning, preparation and review of investigational new drugs applications (INDs), Clinical Trial Applications, new drug applications (NDAs), market authorization application (MAA) and all related annual reports, DMFs, amendments, supplements as well as their ongoing maintenance. The Manager will also lead the preparation and review of regulatory submissions (CMC sections) as well as CMC related responses and inquiries from regulatory agencies. We are seeking a talented Manager to help develop (CMC) regulatory strategies and provide (CMC) regulatory guidance to cross-functional teams and key stakeholders while acting as the primary regulatory (CMC) contact for ongoing projects and responsibilities.

PRIMARY RESPONSIBILITIES:
  • Lead the preparation and review (of CMC sections) of relevant regulatory submissions, as well as the interactions and responses with regulatory agencies
  •   Develop global CMC regulatory strategies for one or more investigational and marketed products
  • Collaborate with US & International regulatory colleagues in development of global CMC regulatory strategies and submissions
  • Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
  • Work effectively on cross-functional teams and be the primary regulatory CMC contact for assigned products and projects
  • Become a key resource for relevant personnel to provide regulatory advice to help guide CMC development activities

SKILLS & REQUIREMENTS:
  • Bachelor’ s Degree required, Advanced Degree preferred in appropriate field with 5+ years Regulatory experience in biotech or pharmaceutical industry
  • Regulatory affairs (CMC) experience (or relevant experience), preferably in Phase 3 studies
  • Solid understanding of full drug development process
  • Thorough understanding of U.S. and Euro regulatory requirements and the operating characteristics or regulatory agencies
  • Experience in developing or assisting the regulatory strategy of all stages of drug development from IND to market approval
  • Familiarity with accelerated regulatory pathways a plus
  • RAPS certification a plus
  • Ability to identify and remedy key regulatory issues and to anticipate potential regulatory hurdles
  • Energetic, positive team player

Tracey Goldthwaite
Senior Vice President

Tracey has more than 20 years experience in the staffing and recruiting industry. She spearheads The Steely Group's Client Services efforts, ensuring superior customer service, communication, and ongoing support to clients and candidates alike. Additional areas of expertise include client relationship management and team building.
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