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Executive/ Assistant Manager - Regulatory Affairs

Wockhardt
Wockhardt
3+ years
Not Disclosed
10 Oct. 4, 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

About This Role

Job Description:

We are seeking a professional with 4-6 years of experience in managing the pre- and post-approval life cycle of biologic products across various markets, including Regulated (EU/US/Canada) and Emerging Markets.

Key Responsibilities:

  • Demonstrate a solid understanding of the regulatory framework, including regional trends, for different types of applications and procedures.
  • Support the compilation, submission, and approval of country-specific submission files (MAA, LCM, and post-approval changes).
  • Contribute to the preparation and delivery of regulatory maintenance submissions, starting with simpler documents and advancing to more complex submissions from a global and/or regional perspective.
  • Assist affiliates in updating local requirements based on guidance from regulatory agencies and input from affiliates/distributors.
  • Maintain a strong understanding of local and international regulatory guidelines.
  • Prepare and review Marketing Authorization Applications and Variations for various medicinal products for filing in Regulated, Emerging, and EU markets.
  • Collaborate closely with cross-functional team members aligned with product responsibilities.
  • Execute and maintain submission delivery plans and content plans, proactively providing status updates to relevant stakeholders.
  • Utilize Regulatory Information Management Systems, such as Veeva Vault.
  • Exhibit strong communication skills and the ability to work independently, with effective collaboration abilities.

If you are interested in this role and meet the qualifications, we encourage you to apply!