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Regulatory Affairs
Thepharmadaily
posted 2mon ago
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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:
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.
Employment Type: Full Time, Permanent
Functional Areas: Other
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