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Senior Manager, Regulatory Affairs (Gen Med / Biosimilars)

6-8 years years
Not Disclosed
10 Sept. 2, 2025
Job Description
Job Type: Full Time Education: Doctorate degree OR Master’s degree (scientific field) with 6 years of directly related experience OR Bachelor’s degree (scientific field) with 8 years of directly related experience 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:

Senior Manager, Regulatory Affairs (Gen Med / Biosimilars)
International Regulatory Lead


Job Details:

  • Job ID: R-221826

  • Location: India – Hyderabad

  • Work Location: On-site

  • Date Posted: July 29, 2025

  • Category: Regulatory

  • Company: Amgen


Group Purpose:

International Regulatory Affairs provides regulatory leadership and expertise for the development, registration, and lifecycle management of all Amgen molecules globally.


Job Summary:

The Senior Manager – International Regulatory Lead is responsible for leading regulatory strategy and compliance for one or more complex Amgen products with high impact. The role involves optimizing product development, ensuring regulatory compliance, and collaborating across global and regional teams.


Key Responsibilities:

Strategy & Execution

  • Advise global teams on regulatory implications for clinical development and marketing applications

  • Provide regulatory direction on mechanisms to optimize product development (e.g., orphan drug designation, expedited pathways)

  • Plan and execute regulatory submissions including clinical trial applications and marketing authorizations

  • Develop and communicate international regulatory strategies and contingency plans

  • Maintain CTA/MA documentation and support regulatory filings, including authoring and redaction as needed

  • Lead internal discussions for agency meetings and communicate outcomes

  • Direct international product labeling strategy in collaboration with the Labeling Working Group

  • Manage label submission strategy and negotiations with cross-functional teams

  • Support local regulatory teams with health authority queries and knowledge management

  • Advise on review of promotional and non-promotional materials

  • Participate in process improvement and metrics initiatives

Communication & Collaboration

  • Actively participate in Global Regulatory Team (GRT), Evidence Generation Team (EGT), Labeling Working Group (LWG), Clinical Study Team (CST), and other cross-functional teams

  • Share regulatory insights and advice on international considerations with global teams

  • Provide guidance on local label deviation requests

  • Partner with peers to align on product strategy and submission timelines

  • Maintain communication with local teams to ensure alignment and inform on product status

  • Build effective relationships across global and local regulatory functions

Regulatory Research

  • Stay updated on new and evolving legislation, policies, and regulatory guidance

  • Conduct regulatory research on precedents and relevant histories to support product advancement

Mentoring

  • Mentor and advise junior International Regulatory Leads


Knowledge & Skills:

Scientific & Technical

  • Strong knowledge of regulatory principles, policies, procedures, and SOPs

  • Comprehensive understanding of regulatory activities and their impact

  • Familiarity with national legislation and regulations for medicinal products

  • Awareness of registration procedures for CTAs, MAs, and lifecycle management

  • Understanding of drug development processes

  • Ability to anticipate agency questions and prepare responses

Other Skills

  • Excellent teamwork and communication (oral and written)

  • Strong negotiation and influencing skills

  • Ability to understand and communicate scientific and clinical information

  • Conflict resolution skills and ability to guide toward beneficial outcomes

  • Cultural sensitivity for working across regions and countries


Education & Experience:

  • Doctorate degree
    OR

  • Master’s degree (scientific field) with 6 years of directly related experience
    OR

  • Bachelor’s degree (scientific field) with 8 years of directly related experience


Preferred Experience:

  • In-depth regulatory experience related to the region

  • Detailed knowledge of legislation and regulations across regional countries for medicinal products


Apply Now

For more details and application, visit: Amgen Careers


Equal Opportunity Statement:

Amgen is an Equal Opportunity Employer. We provide reasonable accommodations to individuals with disabilities to participate in the job application or interview process, perform essential functions, and receive benefits and privileges of employment.