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Senior Regulatory Affairs Associate-Biologics

Parexel
Parexel
4-8 years
Not Disclosed
10 Sept. 26, 2024
Job Description
Job Type: Full Time 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

Job Opportunity: Senior Regulatory Affairs Associate

About This Role:

We are seeking a Senior Regulatory Affairs Associate with 4-8 years of relevant experience in managing the lifecycle of drug products, including both small molecules and biologics, across various markets.

Key Responsibilities:

  • Demonstrate a solid understanding of the regulatory framework and regional trends for different application types and procedures.
  • Contribute to the preparation (including authoring when relevant) and submission of regulatory maintenance documents, progressing from simple to more complex submissions from a global and/or regional perspective.
  • Possess working knowledge of EU and US regulatory procedures, including post-approval requirements. Familiarity with ROW market regulations is an advantage.
  • Handle CMC-related health authority queries effectively.
  • Prepare and review Marketing Authorization Applications and variations for various medicinal products (orals and parenterals) for filing in the EU via DCP, MRP, or National Procedures.
  • Develop documentation for various Variation procedures, including Super grouping, Grouping, and Work-sharing for Marketing Authorizations.
  • Conduct regulatory reviews of DMFs, batch records, specifications, and stability data to ensure compliance with regulatory requirements.
  • Provide regulatory impact assessments for change proposals and identify required documentation for EU submissions.
  • Collaborate closely with cross-functional teams aligned with product responsibilities.
  • Execute and maintain submission delivery plans and content plans, providing proactive status updates to stakeholders.
  • Prepare, review, and submit safety variations to Health Authorities and manage post-approval CMC updates as needed.
  • Utilize Regulatory Information Management Systems, such as Veeva Vault.
  • Exhibit strong communication skills and the ability to guide and mentor team members.
  • Work independently while effectively managing responsibilities.

If you’re ready to take the next step in your career and contribute to our regulatory excellence, we would love to hear from you!