Regulatory Affairs Professional

2 days ago

Delhi, Delhi, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

About a global leader in talent research and pipelining, we offer international reach and complement clients in-house needs.

Our healthcare client provides marketing & commercial solutions across SEA & India. The current job opportunity is with a Singapore based, healthcare multi-national company with operations in SEA, Middle East and North Africa with established plan for global expansion.

We are seeking a Regulatory Affairs Manager to ensure all products comply with applicable laws, regulations, and standards as per Indian laws.

  • Maintain up-to-date knowledge of regulatory changes and assess their impact on the company's products or processes.
  • Prepare or coordinate regulatory documents such as dossiers, technical files, and applications for product approval or licensing.
  • Follow-up with regulatory agencies to get approval of medical devices / pharmaceutical products.
  • Collaborate with Originator, and marketing teams to ensure product alignment with regulatory requirements.
  • Lead or assist in regulatory audits conducted by agencies or certification bodies.
  • Identify and mitigate regulatory risks that could impact product approvals or market access.
  • Develop and implement regulatory strategies to accelerate market entry and ensure sustained compliance.
  • Conduct training sessions for cross-functional teams on regulatory requirements and best practices.

Requirements:

  • Bachelor's degree in a related field. Advanced degree (e.g., MBA, MS, or Ph.D.) is an advantage.
  • Strong knowledge of regulatory requirements (CDSCO, FDA, EMA, MHRA, TGA, etc.) and global standards (ISO, ICH, etc.).
  • Excellent project management and organizational skills.
  • Ability to analyze and interpret complex regulations.
  • Proficient in regulatory writing and submission tools.
  • Strong communication and interpersonal skills.
  • Ability to manage multiple projects and meet deadlines.

Experience: 7-10 years of experience in regulatory affairs, with a proven track record of successful submissions and approvals. Experience in handling registration of Medical Devices and getting approval.

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