Regulatory Affairs CMC Manager

  • location: Cambridge, MA
  • type: Temporary
  • salary: $65 - $80 per hour
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job description

Regulatory Affairs CMC Manager

Regulatory Affairs CMC, Manager/Sr Manager at Global Biotech/Pharma Cambridge, MA
Contract; ASAP through end of year

Job Description:
Reporting to the Head, Regulatory Affairs CMC, the Manager/Sr. Manager, CMC Regulatory Affairs will be based at the Cambridge site and will be responsible for preparing CMC and Quality related agency correspondence and regulatory applications, as well as govern CMC submissions and regulatory compliance support for the development of global products. This position will oversee all aspects of regulatory activities to support high quality CMC sections of regulatory documentation.

Responsibilities:
Develop effective CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks
??? Provide guidance for regulatory CMC aspects of product development projects
??? Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines
??? Contribute in the Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions
??? Develop regulatory processes and procedures to support CMC components of regulatory submissions
??? Support the creation and maintenance of CMC submission templates
??? Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls??? Provides interpretation of regulatory guidance documents, regulations and directives ??? advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs

Working hours: 8:30 AM - 5:30 PM

Skills:
Qualifications:
--BA/BS degree in a scientific/engineering discipline
--8+ years of experience in the Pharmaceutical industry
--4+ years of experience in Regulatory CMC, including DMF/ASMF submissions
--Strong knowledge of current US and EU regulations and cGMP
--Strong experience with CTD format and content regulatory filings
--Exceptional written and oral communication

Education:
Masters

Experience:
Manager

Qualifications:
Qualifications Preferred:
??? M.S. degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable
??? 12 years of experience in regulatory in the pharmaceutical/biotech industry
??? 6+ years of experience in Regulatory CMC


Please contact: lauri.marsanne@randstadusa.com or 475-549-8806

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