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Regulatory Affairs Specialist

2 weeks ago

Daman, Daman and Diu, India beBeeRegulatoryAffairs Full time ₹ 9,00,000 - ₹ 12,00,000

Global Regulatory Affairs Specialist

We are seeking an experienced Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for developing and implementing global regulatory strategies to ensure timely product approvals and market access across multiple health authorities.

The ideal candidate will have a strong background in regulatory affairs, with experience in developing and implementing global regulatory strategies. They will also have excellent communication and project management skills, with the ability to work effectively in a fast-paced environment.

This is a challenging and rewarding role that requires a high level of expertise and attention to detail. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.

  • Develop and implement global regulatory strategies to ensure timely product approvals and market access across multiple health authorities.
  • Provide regulatory intelligence and strategic advice to senior management on evolving regulations and their potential impact on business.
  • Collaborate with R&D, Quality, Manufacturing, and Marketing teams to align regulatory activities with overall business goals.
  • Prepare, compile, and submit controlled correspondence, pre-submission meeting requests, and scientific advice for US, EU, Canada, and other global markets.

Responsibilities:

  • Evaluate pre-PIFs and provide regulatory submission requirements for US & EU, with extended submissions for Australia, Canada, and other regions.
  • Define and implement regulatory strategies to ensure business continuity and Day 1 launches in Europe, Canada, Australia, UK, China, and other key markets (Type IA/IB/II Supplements, Category 3 Notifications).
  • Author and review CMC documentation (dossiers, technical files, deficiency responses), ensuring technical accuracy and compliance with agreed regulatory strategies.
  • Lead cross-functional teams for new product development, regulatory submissions, and post-approval lifecycle management.

Requirements:

  • Experience: 12+ Years (relevant regulatory affairs experience)
  • Qualification: M.Pharm
  • Excellent communication and project management skills
  • Ability to work effectively in a fast-paced environment