Senior Regulatory Compliance Specialist

2 days ago

Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 30,00,000 - ₹ 50,00,000

**Job Title:** Senior Regulatory Manager

As a seasoned professional in the field of Regulatory Affairs, we are seeking an individual with extensive experience in biologics/biosimilars registration across Emerging Markets. This role is responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates, partners, and health authorities to ensure timely approvals and post-approval compliance.

Key Responsibilities:

  • Prepare, review, and submit regulatory dossiers (CTD/eCTD or country-specific formats) for biosimilars in Emerging Markets.
  • Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, CIS countries, ASEAN, LATAM, and Africa.
  • Support product registrations, renewals & variations.
  • E nsure proper submission planning and regulatory timelines to support product launches and lifecycle management.
  • Respond to health authority queries in coordination with CMC, clinical, and quality teams.
  • Maintain a regulatory dashboard, submission tracker, and repository of country-specific requirements and timelines.
  • Understand local regulatory pathways for biosimilars/biologics: reliance, abridged reviews, priority review, etc.
  • Familiarity with GCC-CTD, ASEAN CTD, and regional WHO biosimilar guidelines.
  • Experience working with local affiliates or partner companies in Emerging Markets.
  • Prior exposure to biosimilar guidelines in WHO, GCC, SAHPRA, INVIMA, ANVISA, etc.
  • Experience with regional electronic submission platforms.

Qualifications:

  • Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, or related field.
  • Proven track record in filing and obtaining approvals for biologics/biosimilars in Emerging Markets.
  • Knowledge of CTD structure, Module 1 customization, and regional submission formats.
  • Strong project management, communication, and stakeholder coordination skills.

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