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Sr. Director, Regulatory Affairs Strategy

10+ years
Not Disclosed
10 July 16, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Senior Director, Global Regulatory Affairs Strategy

Company: Sun Pharma


Position Overview:

The Senior Director, Global Regulatory Affairs Strategy will provide strategic leadership for the company's novel drug development programs. The individual will be responsible for developing and executing the overall regulatory strategy for each program, which includes determining the registration pathway, interacting with regulatory agencies, and managing all associated regulatory filings.

Key Responsibilities:

  • Regulatory Strategy Development: Develop and execute novel drug regulatory strategies.
  • Compliance: Ensure development programs comply with ICH regulatory requirements and all local country regulatory requirements.
  • Project Management: Exhibit strong project management skills and interpersonal skills to handle complex distributed programs.
  • Regulatory Documentation: Author clear and concise regulatory documents and oversee all documents for regulatory submissions and associated messaging.
  • Collaboration: Work closely with the regulatory CMC lead and the overall development team to ensure alignment between the overall regulatory strategy and regulatory CMC strategy.
  • Regulatory Liaison: Act as the point of contact between the company and regulatory agencies, serving as the regulatory liaison for the company.

Qualifications:

  • Educational Requirements:
    • Mandatory: Master’s degree in Chemistry, Biochemistry, Pharmacy, Biomedical Engineering, or Chemical Engineering.
    • Preferred: PhD or PharmD in the above disciplines.
  • Experience:
    • Minimum of 10+ years of industry experience in regulatory affairs for novel drug development.
    • Experience with CMC and/or Botanical products.
    • RAC certification preferred.
  • Knowledge and Skills:
    • Thorough understanding of ICH and US CFR requirements and regulations.
    • Experience in authoring regulatory document submissions, including INDs, IMPDs, NDAs, BLAs, and briefing books.
    • Direct interaction experience with regulatory agencies.
    • Strong communication skills.

About Sun Pharma:

Sun Pharma is a leader in the biotechnology industry, focused on developing innovative treatments to address life-threatening diseases. We are dedicated to advancing the promise of novel therapies through strategic partnerships and cutting-edge research.

Sun Pharma is an equal opportunity employer committed to creating a diverse and inclusive workplace.