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Regulatory Affairs Senior Manager (Cmc)

3-5 years years
Not Disclosed
10 Sept. 2, 2025
Job Description
Job Type: Full Time Education: Doctorate degree OR Master’s degree with 3 years of directly related experience OR Bachelor’s degree with 5 years of directly related experience OR Associate’s degree with 10 years of directly rela 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 Title:

Regulatory Affairs Senior Manager (CMC)


Job Details:

  • Job ID: R-223044

  • Location: India – Hyderabad

  • Work Type: On-site

  • Date Posted: August 29, 2025

  • Category: Regulatory

  • Company: Amgen


About the Role:

The RA CMC Senior Manager is responsible for the execution and coordination of global regulatory CMC activities. This includes providing leadership, guidance, and strategic oversight for the regulatory strategy of assigned commercial products. The role involves communicating regulatory strategy, risks, and issues to senior management and collaborating with site and regional CMC representatives to ensure successful global regulatory activities.


Key Activities:

  • Serve as Global RA-CMC lead or supervisor for one or more products within product teams

  • Provide strategic regulatory input and risk assessments for product teams

  • Execute regulatory strategy related to preparation of submissions and ensure compliance with critical RA CMC processes

  • Identify and recommend process and strategy changes aligned with Amgen initiatives and external regulatory policies

  • Incorporate changes in regulatory guidance into CMC strategies and provide updated guidance to product teams

  • Report issues to RA CMC product team management


Key Responsibilities:

  • Oversee CMC strategy deliverables and submissions for a portfolio of products at various development stages

  • Engage with external stakeholders such as regulatory agencies and professional bodies to influence regulatory policy globally

  • Identify and communicate regulatory risks, ensuring aligned mitigation plans across products

  • Provide coaching, mentoring, and support for junior CMC Regulatory Affairs staff development

  • Define minimal regulatory filing requirements, submission strategies, and conduct regulatory risk assessments for assigned projects

  • Develop and execute response strategies for health authority questions

  • Collaborate with development, operations, and commercial teams to align regulatory strategies, timing, execution, and supply plans

  • Coordinate with local regulatory teams to align filing strategies

  • Monitor and update tracking systems and maintain submission data in the Regulatory Information Management (RIM) system

  • Follow established regulatory processes to ensure alignment across products


Knowledge and Skills:

  • Deep regulatory CMC-specific knowledge and experience

  • Experience in staff management and development


Education & Experience (Basic):

  • Doctorate degree
    OR

  • Master’s degree with 3 years of directly related experience
    OR

  • Bachelor’s degree with 5 years of directly related experience
    OR

  • Associate’s degree with 10 years of directly related experience

Additional Experience:

  • Experience in manufacturing, testing (QC/QA or clinical), or distribution

  • Regulatory CMC experience


What You Can Expect from Amgen:

  • Support for professional and personal growth and well-being

  • Competitive benefits and collaborative culture

  • Comprehensive Total Rewards Plans aligned with local industry standards

  • Inclusive work environment fostering diversity, ethics, and commitment to science and patients


Equal Opportunity Statement:

Amgen is an Equal Opportunity employer and considers applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other protected basis under applicable law.

Reasonable accommodations are provided for individuals with disabilities during the hiring process and employment. Please contact Amgen to request accommodations.


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