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Senior Manager, CMC Regulatory Affairs

2 months ago

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

Position: Senior Manager in Regulatory & Medical Affairs - CMC

Work Arrangement: Hybrid (50% onsite)

Compensation: Competitive hourly rate

Key Responsibilities

The successful candidate will be responsible for a variety of tasks, including but not limited to:

  • Contributing to the formulation of the CMC regulatory strategy for post-approval submissions of small molecule products, encompassing global variations and responses to inquiries from health authorities.
  • Drafting and reviewing CMC submission documents, registration dossiers, and health authority responses in collaboration with relevant departments, requiring minimal oversight.
  • Possibly overseeing the global regulatory assessment of CMC change controls under guidance.
  • Collaborating with cross-functional CMC teams and Regulatory Affairs departments.
  • Maintaining up-to-date knowledge of the regulatory landscape, including relevant regulations and procedures.
Required Skills and Expertise

The ideal candidate will possess:

  • Proficiency in CMC regulatory documentation (global registrations, including NDAs, MAAs, and other submissions).
  • Familiarity with FDA, EMA, and/or ICH guidelines and CMC regulations.
  • Experience with post-approval regulatory requirements.
  • Ability to develop CMC regulatory strategies.
  • Strong project management skills.
  • A solution-oriented mindset for problem-solving.
  • Capability to organize and prioritize the work of team members while mentoring others.
  • Experience working on intricate projects within cross-functional teams with some supervision.
  • Exceptional written and verbal communication skills.
  • Strong computer proficiency.
Additional Skills

Further skills and qualifications may be considered advantageous but are not mandatory.