Regulatory Affairs Consultant

8+ years

Not Disclosed

Chandigarh Hyderabad Mohali

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 Description:

We are looking for a highly experienced professional with 8+ years in lifecycle management of approved drug products, including tablets (oral solids), syrups (oral liquids), and parenterals (injectables) for the EU market.

Key Responsibilities:

Demonstrate a strong understanding of the regulatory framework and regional trends for various application types and procedures.
Lead or contribute to the planning, preparation (including authoring when relevant), and submission of regulatory maintenance documents, starting with simpler submissions and progressing to more complex ones from a global and/or regional perspective.
Possess working knowledge of EU/US regulatory procedures, including post-approval requirements. Familiarity with ROW market regulations is a plus.
Handle CMC-related health authority queries effectively.
Understand the regulatory landscape for small and large molecules across all regions, including knowledge of global pharmaceutical legislation and ICH guidance related to CMC.
Collaborate closely with cross-functional teams aligned with product responsibilities.
Develop, execute, and maintain submission delivery plans and content plans, providing proactive status updates to stakeholders.
Prepare, review, and submit safety variations to Health Authorities, along with managing post-approval CMC updates as needed.
Prior experience with Regulatory Information Management Systems, such as Veeva Vault, is desirable.
Exhibit strong communication skills and the ability to work independently.

If you are ready to contribute to our mission and drive regulatory excellence, we would love to hear from you!

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Regulatory Affairs Consultant

Job Description

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