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Sr. Manager Regulatory Affairshy

5+ years
Not Disclosed
10 Jan. 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Sr. Manager Regulatory Affairs
Location: India - Hyderabad
Work Location Type: On Site
Date Posted: Jan. 10, 2025
Job ID: R-203319


Job Category: Regulatory


Job Description

The Senior Manager, Regulatory Affairs (CMC) is responsible for overseeing and executing global regulatory CMC (Chemistry, Manufacturing, and Controls) activities. This role involves developing and implementing regulatory strategies, guiding teams, and ensuring successful execution of CMC-related tasks for assigned commercial products. The role also requires collaboration with site and regional CMC representatives to streamline global regulatory activities.


Roles & Responsibilities

  • Regulatory Strategy: Develop and implement CMC regulatory strategies for assigned commercial products.
  • Leadership & Guidance: Provide leadership and guidance to teams, ensuring alignment with regulatory goals.
  • Risk Management: Communicate regulatory strategies, risks, and issues to senior management in Regulatory Affairs and Operations.
  • Collaboration: Coordinate with site and regional CMC representatives to execute global regulatory activities effectively.
  • Team Oversight: Manage staff as needed, ensuring efficient execution of responsibilities.

Key Competencies

  • Expertise in CMC regulatory requirements and processes.
  • Strong leadership and communication skills to manage cross-functional teams.
  • Strategic thinking with the ability to assess risks and provide solutions.
  • Proficiency in managing global regulatory activities in alignment with company objectives.

What You Can Expect

Amgen offers a competitive salary and a supportive environment for professional growth. Join a team dedicated to shaping a healthier world.