Regulatory Affairs Associate (Biologics)

4+ years

Not Disclosed

Remote

10 Oct. 4, 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 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!

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Regulatory Affairs Associate (Biologics)

Job Description

Key Responsibilities:

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