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Regulatory Affairs Manager

Humano Forte


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4-10 Years
2 months ago
97 Viewed
5 Applied

Job Description

Job Title: Regulatory Affairs Manager

As the Regulatory Affairs Manager, you will play a crucial role in ensuring compliance with regulatory requirements across various regions. You will guide our organization through the complexities of global regulatory landscapes and contribute to the successful market access of our products.


  • Develop and implement regulatory strategies to support product registrations and approvals in target international markets.
  • Stay abreast of global regulatory requirements, trends, and changes, and provide strategic insights to cross-functional teams.
  • Lead the preparation, submission, and maintenance of regulatory documents for product registrations, including New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), and other relevant submissions.
  • Collaborate with regulatory agencies to address inquiries and facilitate timely approvals.
  • Work closely with cross-functional teams, including R&D, Quality Assurance, Clinical Affairs, and Legal, to ensure regulatory compliance throughout the product lifecycle.
  • Provide regulatory guidance and support to internal stakeholders to facilitate decision-making processes.
  • Conduct risk assessments and proactively identify potential regulatory issues or challenges.
  • Develop and implement risk mitigation strategies to ensure successful regulatory outcomes.
  • Monitor and analyze changes in international regulatory requirements and communicate updates to relevant stakeholders.
  • Proactively identify opportunities for regulatory process improvement and optimization.


  • Bachelor's degree in a B-Pharmacy or M-Pharmacy.
  • 4 to 10 years of progressive experience in regulatory affairs, with a focus on international markets.
  • Strong understanding of global regulatory requirements and processes, including FDA, EMA, Health Canada, and other major regulatory agencies.
  • Experience with regulatory submissions and approvals in multiple countries.
  • Excellent communication and interpersonal skills, with the ability to build relationships with regulatory authorities.

Location: Pune, Maharashtra

If you are interested or know anyone who might be, Please send your resume to [Confidential Information]

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