Regulatory Affairs Associate (Biologics)

4-6 years

Not Disclosed

Remote

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.

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Regulatory Affairs Associate (Biologics)

Job Description

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