Global Head of Regulatory Affairs

3 weeks ago

Ahmedabad, Gujarat, India Kashiv BioSciences Full time
Job Title: Global Head of Regulatory Affairs

We are seeking a highly skilled and experienced individual to fill the role of Global Head of Regulatory Affairs at Kashiv BioSciences. The successful candidate will be responsible for the overall leadership and strategic direction of the regulatory affairs function within the company.

Key Responsibilities:
  • Develop and implement global regulatory strategies for biosimilar products to ensure timely approvals in target markets.
  • Oversee the planning and execution of regulatory submissions (INDs, BLAs, MAAs, etc.) and ensure alignment with business objectives.
  • Assess regulatory risks and provide strategic input to minimize obstacles to product approvals and lifecycle management.
  • Lead the preparation, review, and submission of regulatory documents, including clinical trial applications, marketing authorizations, and amendments.
  • Ensure the accuracy, quality, and compliance of all regulatory submissions.
  • Manage and coordinate responses to regulatory authorities' questions, ensuring timely and effective communication.
  • Ensure all company activities comply with applicable regulatory requirements and guidelines (FDA, EMA, ICH, etc.).
  • Monitor and interpret global regulatory trends, changes in regulations, and guidance documents relevant to biosimilars.
  • Advise internal teams on regulatory requirements, risks, and opportunities to ensure compliance throughout the product lifecycle.
  • Serve as the primary contact with global regulatory agencies.
  • Lead and participate in meetings with regulatory authorities, including pre-submission meetings, scientific advice, and advisory committee meetings.
  • Negotiate and communicate effectively with regulatory agencies to achieve favourable outcomes.
  • Work closely with cross-functional teams to ensure regulatory strategies are integrated into product development plans and ensure alignment with regulatory requirements and timelines.
  • Build, lead, and mentor a high-performing global regulatory affairs team.
  • Ensure effective resource allocation, budgeting, and project management for regulatory activities.
  • Oversee the development and approval of product labelling, including package inserts, patient information leaflets, and promotional materials.
  • Ensure post-marketing surveillance and reporting requirements are met, including safety updates and annual reports.
  • Manage post-approval changes, including variations, renewals, and line extensions, ensuring continued compliance.
Requirements:
  • Masters in Pharma / Bio Pharma (Regulatory Science, Pharmaceutical Science, Biotechnology, etc.).
  • Preferable experience in biosimilars and biologics products globally.
  • Extensive experience with regulatory submissions and approvals for biosimilars or biologics in global markets.
  • Proven track record of successful interactions with global regulatory agencies such as FDA, EMA, etc. and in-depth knowledge of Export and import regulations, including GCP, ICH guidelines, and local regulations.

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