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Regulatory Affairs Manager

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

Regulatory Affairs Manager
Location: India - Hyderabad
Work Location Type: On Site
Date Posted: Jan. 10, 2025
Job ID: R-203316


Job Category: Regulatory


Job Description

The Regulatory Affairs Manager (CMC) will oversee the execution and coordination of global regulatory Chemistry, Manufacturing, and Controls (CMC) activities. The role requires providing leadership, guidance, and insights to ensure the successful implementation of regulatory strategies for assigned commercial products. This individual will act as a key communicator of regulatory strategies, risks, and issues to senior management and collaborate with site and regional CMC representatives to align and execute global regulatory activities.


Roles & Responsibilities

  • Strategy Implementation: Develop and execute CMC regulatory strategies for assigned products.
  • Leadership: Provide guidance and insights to ensure effective execution of regulatory activities.
  • Risk Communication: Inform senior management of regulatory strategies, associated risks, and potential issues.
  • Collaboration: Coordinate with site and regional CMC representatives to develop and execute global activities.

Key Competencies

  • Proficient understanding of global CMC regulatory requirements and industry best practices.
  • Strong communication and leadership skills for guiding teams and stakeholders.
  • Ability to identify and mitigate risks associated with regulatory strategies.
  • Skilled in managing collaborative efforts across global sites and regions.

What You Can Expect

Join Amgen’s mission to advance global health. With competitive benefits and a culture of innovation, this is an opportunity to make a significant impact.