Senior Director, Regulatory Affairs Strategy Lead

2 days ago


Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

Strategic Regulatory Affairs Leadership

The Senior Director, Regulatory Affairs Strategy will provide regulatory affairs strategic leadership for Sun Pharmaceutical Industries, Inc. and novel drug development programs. This position will be responsible for developing and executing the overall regulatory strategy, including developing the registration pathway, interacting with regulatory agencies, and ensuring all associated regulatory filings are compliant with ICH and local country regulations.

Key Responsibilities

  • Develop and execute novel drug regulatory strategies to ensure compliance with ICH and local country regulations
  • Ensure development programs are aligned with regulatory requirements and strategies
  • Provide strong project management and interpersonal skills to handle complex distributed programs
  • Author clear and concise regulatory documents for submissions and messaging
  • Collaborate with regulatory CMC leads and development teams to ensure overall regulatory strategy and CMC strategy are aligned
  • Serve as the regulatory liaison between the company and regulatory agencies

Qualifications

  • Master's degree in Chemistry, Biochemistry, Pharmacy, Biomedical Engineering, or Chemical Engineering is mandatory; PhD or PharmD in above disciplines are preferred
  • 10+ years industry experience in RA novel drug development is a must
  • CMC and/or Botanical experience, RAC certification
  • Thorough understanding of ICH and US CFR requirements and regulations
  • Regulatory document submissions authoring experience (INDs, IMPDs, NDAs, BLAs, briefing books)
  • Regulatory agency direct interaction experience
  • Strong communications skills

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