Sr. Regulatory Affairs CMC Lead

Cambridge, MA

Posted: 10/17/2023 Industry: Scientific Job Number: 23-00512

Job Description

The Role:

The Sr. Regulatory Affairs CMC Lead will be support regulatory CMC activities for one or more programs. They will provide input on regulatory CMC pre-approval support and collaborate with key stakeholders to prepare regulatory submissions and Health Authority communications. They will need to successfully manage multiple projects in a fast and results-oriented environment.

What You'll Do:
  • Support development of CMC regulatory 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
  • Support 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

Minimum Qualifications
  • BA/BS degree in a scientific/engineering discipline
  • 6+ years of experience in the Biotechnology/Pharmaceutical industry
  • Knowledge of current US and EU regulations and cGMP
  • Experience with CTD format and content regulatory filings
  • Exceptional written and oral communication

Preferred Qualifications
  • BS or MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable
  • 6+ years of experience in regulatory in the pharmaceutical/biotech industry
  • 4+ years of experience in Regulatory CMC is desirable
  • Pre-approval and QA/QC experience preferred
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.

Meet Your Recruiter

Alyssa Darden

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