Regulatory Affairs Expert for Pharmaceutical Compliance

4 weeks ago


Bengaluru, Karnataka, India Parexel Full time

Unlocking Global Regulatory Excellence

About the Role

Parexel is seeking an experienced Regulatory Affairs Consultant to join our team. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with regulatory requirements for biologic products in various markets.

Responsibilities

  • Support the compilation, submission, and approval of country-specific submission files (MAA, LCM, and post-approval changes) from a global and/or regional perspective.
  • Collaborate with cross-functional members to ensure alignment on product responsibilities and execute submission delivery plans.
  • Liaise with regulatory agencies and provide input on local requirements based on guidance.
  • Maintain knowledge of local and international regulatory guidelines.
  • Prepare and review Marketing Authorization Applications & Variations for filing in Regulated, Emerging, and EU markets.

Requirements

  • 8-9 years of experience in handling pre and post-approval life cycle management of Biologic products in regulated (EU/US/Canada) and emerging markets.
  • Strong understanding of regulatory frameworks, including regional trends, for various types of applications and procedures.
  • Experience working with Regulatory Information Management Systems like Veeva Vault.
  • Effective communication and collaboration skills.

What We Offer

  • An estimated salary range of $120,000 - $150,000 per annum, depending on location and experience.
  • A dynamic and supportive work environment.


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