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Regulatory Affairs Associate (Biologics)

Parexel
Parexel
4-6 years
Not Disclosed
10 Oct. 7, 2024
Job Description
Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About This Role
Job Description:

We are seeking a candidate with 4-6 years of experience in managing the pre- and post-approval lifecycle of biologic products across various markets, including regulated regions (EU/US/Canada) and emerging markets.

Key Responsibilities:

  • Demonstrate a strong understanding of the regulatory framework and regional trends for different application types and procedures.
  • Support the compilation, submission, and approval of country-specific submission files, including Marketing Authorization Applications (MAA), lifecycle management (LCM), and post-approval changes.
  • Contribute to the preparation and delivery of regulatory maintenance submissions, authoring content as necessary, and increasingly handling complex submissions from a global and/or regional perspective.
  • Assist affiliates in updating local requirements based on regulatory agency guidance and feedback from affiliates/distributors.
  • Prepare and review Marketing Authorization Applications and variations for various medicinal products intended for filing in regulated, emerging, and EU markets.
  • Collaborate closely with cross-functional teams aligned with product responsibilities.
  • Execute and maintain submission delivery plans and content plans, proactively providing status updates to stakeholders.
  • Utilize Regulatory Information Management Systems, such as Veeva Vault.
  • Exhibit strong communication skills and the ability to work independently, while effectively collaborating with others.