Associate Reg Affairs CMC Director

MacroGenics   •  

Rockville, MD

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 181 days ago

This job is no longer available.

Summary of Position

The Associate Regulatory Affairs CMC Director will provide regulatory guidance to ensure development activities, manufacturing, and testing for all MacroGenics products are compliant with the relevant regulations, guidelines and industry standards. Responsibilities include collecting, reviewing and assembling CMC-related submission documentation, and ensuring appropriate review and approval of submissions prior to submitting to a Regulatory Authority.

  • Develop CMC-related submission content outlines and establish submission timelines in collaboration with relevant project team members; manage execution of submission preparation, review, approval and delivery to the appropriate Regulatory Authority
  • Represent Regulatory Affairs CMC in project meetings as assigned
  • Interact with Process Development, Manufacturing, Quality Assurance and Quality Control personnel contributing to a submission regarding content and timelines; ensure sections provided to Regulatory are consistent with regulatory requirements and internal submission format standards; edit content of submissions based on regulatory requirements
  • Review and provide comments on SOPs, stability protocols, product container labeling, product specifications, comparability protocols and reports, quality agreements, pharmacy manuals, investigator brochures and other related CMC documents
  • Continue professional development by attending regulatory CMC-related meetings applicable to biopharmaceutical products
  • Aid in the implementation of infrastructure necessary for successful completion of regulatory projects (e.g., preparation of Regulatory-related written processes and procedures, review of departmental SOPs, establishment of electronic document standards)
  • Provide support to Senior Director, Regulatory Affairs CMC as requested

Qualifications

Education

Bachelor’s degree in a scientific discipline

Experience

  • At least 8 years in a Regulatory department at biopharmaceutical/pharmaceutical company
  • At least 5 years working with biologics/large molecules with a proven track record in preparing and submitting high quality submissions that meet regional Regulatory Authorities’ requirements
  • Direct experience assembling Regulatory applications in eCTD format

Knowledge, Skills and Abilities

  • Direct experience assembling Regulatory applications in eCTD format
  • Knowledge of FDA, ICH and EMA requirements for biopharmaceutical products required
  • Excellent verbal and written communication skills
  • Strong project management and organizational skills with ability to multi-task on several projects
  • Highly flexible, adaptable and experienced in a fast-paced environment
  • Expertise in MS Office; experience with Electronic Document Management Systems for preparing, formatting, and finalizing regulatory submissions