CMC Regulatory Affairs Specialist Position Available

1 day ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 16,97,000 - ₹ 26,19,000

Job Title:

  • CMC Regulatory Specialist

Job Summary:

  • The CMC Regulatory Specialist will be responsible for finalizing regulatory strategies for assigned products, providing support to execute tasks independently in accordance with global regulations and guidance procedures.
  • They will serve as the CMC Product Lead, accountable for delivering all regulatory milestones through the product lifecycle.
  • The specialist will execute regulatory strategies by leading the development, review, and approval of submission components and documentation to support post-approval supplements and responses to health authority questions.
  • They will lead change control evaluation, preparation, and submission of dossiers for life-cycle changes to commercial products in support of project execution.
  • The specialist will also lead and plan bundling/grouping strategy of variations and geo-expansion strategy of active Marketed products.
  • They will aid in the development and lead execution of global product and project regulatory strategy(s) by ensuring robust assessment of CMC changes, identification of global regulatory requirements, and critical evaluation of supporting documentation.
  • The specialist will provide regulatory leadership as needed to product in-license/due diligence review, product divestment, and product withdrawal.
  • They will collaborate with internal and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on conformance.
  • The specialist will manage execution of CMC documentation, including complex variations, registration renewals, and responses to health authority questions.
  • They will demonstrate a robust understanding of regulatory affairs and apply this understanding to ensure approval and product supply continuity.
  • The specialist will assess and communicate potential risks and propose mitigation strategies.
  • They will deliver all regulatory milestones for assigned products across the product lifecycle, identify, communicate, and escalate potential issues to management, as needed.
  • The specialist will demonstrate ability to generate innovative solutions to complex problems and effectively work with stakeholders.
  • They will demonstrate flexibility in responding to changing priorities or dealing with unexpected events.
  • The specialist will demonstrate effective leadership, communication, interpersonal, and negotiating skills in team environments.

Qualifications:

  • Bachelor's / Master's / Ph.D. degree in science or any life sciences discipline.
  • 10+ years of experience preferred.
  • Strong experience in CMC registration and pre/post-approval submission activities.
  • Proven experience critically reviewing supporting documents and data to ensure adequacy for submission.
  • Superior oral and written communication skills in multicultural settings.
  • Strong listening skills.
  • Sound understanding of related fields and creativity in problem-solving.
  • Relevant CMC pre/post-approval experience.

Key Responsibilities:

  • Develop and execute regulatory strategies for assigned products.
  • Lead the development, review, and approval of submission components and documentation.
  • Manage execution of CMC documentation, including complex variations, registration renewals, and responses to health authority questions.
  • Provide regulatory leadership and collaborate with internal and external partners.
  • Assess and communicate potential risks and propose mitigation strategies.
  • Demonstrate ability to generate innovative solutions to complex problems.

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