Regulatory Affairs Specialist

7 days ago


Hyderabad, Telangana, India Parexel Full time
Senior Regulatory Affairs Associate - Biologics

About the Role

We are seeking a highly skilled Senior Regulatory Affairs Associate to join our team at Parexel. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for biologics products.

Key Responsibilities

  • Develop and implement regulatory strategies for biologics products, ensuring compliance with EU/US regulatory procedures.
  • Prepare and review regulatory submissions, including Marketing Authorization Applications and Variations, for filing in EU through different types of procedures.
  • Conduct regulatory review of DMFs, batch records, specifications, and stability data to ensure compliance with regulatory requirements.
  • Provide regulatory impact assessment for change proposals and identify required documentation for EU submissions.
  • Liaise closely with cross-functional members with aligned product responsibilities.
  • Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
  • Prepare, review, and submit safety variations to Health Authorities and perform post-Approval CMC-related updates.
  • Working experience in Regulatory Information Management Systems like Veeva Vault.
  • Strong communications skills and ability to guide and mentor team members.

Requirements

  • Around 4-8 years of relevant experience in handling of pre and post-approval life cycle management of drug products (small molecules as well as biologics) in various markets.
  • Good understanding of regulatory framework, including regional trends, for various types of applications and procedures.
  • Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
  • Working knowledge of EU/US regulatory procedures including post-approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage.
  • Experience in handling CMC-related health authority queries.
  • Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.

About Us

Parexel is a leading global biopharmaceutical services company, providing a broad range of solutions, from clinical trials to regulatory consulting. We are committed to helping our clients succeed in the rapidly changing healthcare landscape.



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