Senior Manager, CMC Regulatory Affairs

2 weeks ago

Short Hills, New Jersey, United States V R Della Infotech Inc Full time
Job Overview

Position: Senior Manager, Regulatory Affairs - CMC

Work Arrangement: Hybrid (50% onsite)

Compensation: Competitive hourly rate


Role Summary:

The Senior Manager in Regulatory Affairs will play a pivotal role in shaping the CMC regulatory strategy for post-approval submissions of small molecule products. This position requires a deep understanding of regulatory frameworks and the ability to navigate complex submissions.


Key Responsibilities:
  • Contribute to the formulation of CMC regulatory strategies for global submissions, including variations and responses to inquiries from health authorities.
  • Draft and evaluate CMC submission documents and registration dossiers, ensuring compliance and accuracy through collaboration with various departments.
  • Oversee the global regulatory assessment of CMC change controls with appropriate guidance.
  • Collaborate with cross-functional teams in CMC and Regulatory Affairs to ensure alignment and efficiency.
  • Continuously update knowledge of the regulatory landscape, including relevant regulations and procedures.

Required Skills and Knowledge:
  • Proficiency in preparing CMC regulatory documents, including NDAs and MAAs.
  • Familiarity with FDA, EMA, and ICH guidelines related to CMC.
  • Experience in post-approval regulatory requirements.
  • Ability to develop comprehensive CMC regulatory strategies.
  • Strong project management skills.
  • Solution-oriented mindset for addressing challenges.
  • Capability to prioritize and guide the work of team members.
  • Experience working on intricate projects within cross-functional teams.
  • Exceptional written and verbal communication skills.
  • Advanced computer proficiency.

Additional Qualifications:

Applicants should possess a BS/BA in a scientific discipline, with a preference for candidates holding a Master's degree or higher, alongside a minimum of 5 years of experience in the pharmaceutical sector, particularly in CMC regulatory roles.

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