Senior Regulatory Affairs Specialist

4 days ago

Vadodara, Gujarat, India beBeeRegulatory Full time ₹ 1,80,00,000 - ₹ 2,10,00,000

Job Title:

Regulatory Affairs Manager

We are seeking a seasoned Regulatory Affairs Manager to join our regulatory team. This role will be responsible for developing and directing global regulatory strategies, leading the preparation of submission dossiers, and collaborating with cross-functional teams.

Key Responsibilities:

  • Develop and direct global regulatory strategies covering clinical, non-clinical, and CMC aspects.
  • Lead the preparation, review, and approval of submission dossiers for regulatory authorities including major health authorities.
  • Provide strategic guidance on regulatory pathways related to CMC changes and ensure appropriate regulatory compliance.
  • Collaborate with cross-functional teams to ensure timely and compliant regulatory submissions.
  • Manage timelines and coordinate with regulatory agencies to facilitate approvals.
  • Participate in client interactions, trainings, and regulatory development initiatives as required.
  • Lead and manage the regulatory affairs team, driving productivity and compliance.

Qualifications & Skills:

  • 12 to 15 years of relevant experience in regulatory affairs, preferably within the pharmaceutical or related industries.
  • Proven experience in developing and implementing regulatory strategies at a global level.
  • Strong proficiency in preparing and submitting regulatory documentation to major health authorities.
  • Deep understanding of regulatory compliance requirements and industry best practices.

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