Regulatory Affairs Expert

14 hours ago

Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 60,00,000 - ₹ 1,00,00,000

As a Regulatory Affairs Specialist, you will play a critical role in ensuring our products meet local and international standards. We seek a detail-oriented and proactive professional to support strategies, submissions, and compliance activities across global markets.

Key Responsibilities:

Regulatory Submissions & Approvals:

  • Prepare, review, and submit regulatory dossiers for product registrations, renewals, and amendments following local and global guidelines.
  • Maintain submission documentation, including regulatory pathways, risk classifications, labeling, and declarations of conformity.
  • Track and manage regulatory submissions and approval timelines.

Product Lifecycle Management:

  • Ensure regulatory compliance during product changes, including reformulations, labeling updates, and manufacturing site transfers.
  • Review and approve change control documents, product labels, technical files, and packaging for regulatory accuracy.
  • Assist in managing product recalls, adverse event reporting, and field corrective actions, if applicable.

Compliance & Documentation:

  • Monitor changes in global regulations and standards affecting company products and communicate updates to internal stakeholders.
  • Support preparation and maintenance of Technical Files, Product Dossiers, and Master Files.
  • Assist in regulatory audits and inspections (internal and external).

Cross-functional Collaboration:

  • Work closely with R&D, Quality Assurance, Supply Chain, and Legal teams to ensure timely and compliant product launches.
  • Serve as a regulatory point of contact during product development and commercialization.
  • Provide guidance to internal teams on regulatory requirements and best practices.

Requirements:

  • Good understanding of global regulatory frameworks.
  • Strong knowledge of product classification, labeling, and regulatory strategy.
  • Proficient in MS Office Suite, document management systems, and regulatory software.
  • Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, or related field.
  • 3-6 years of experience in Regulatory Affairs within Medical Devices, Pharmaceuticals, Biotech, or FMCG.
  • Regulatory certification (e.g., RAC from RAPS) is a plus.

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