Mindblowing Jobs

Manager - International Regulatory Lead

By Admin · Regulatory Affairs

HYDERABAD (IN)ONSITEPOSTED: 9/13/2026
PHARMAFull-time
HIRING ORGANIZATIONAMGENBiotechnology / Pharmaceuticals
Amgen

ROLE OVERVIEW

Lead international regulatory strategy and execution for Amgen products across international countries. The role provides regulatory expertise for product development, registrations, lifecycle management, labeling strategy and health-authority interactions while coordinating global, regional and local stakeholders.

ROLE DEFINITION & RESPONSIBILITIES

  • •Provide regulatory leadership and guidance to optimize product development and regulatory approvals
  • •Develop international regulatory strategy and contribute to global regulatory plans
  • •Support regulatory product compliance including RIM, PMCs and agency commitments
  • •Advise on local label strategy and alignment with cCDS/reference labels
  • •Plan clinical trial, marketing authorization and lifecycle-management submissions
  • •Develop regulatory filing strategies, risk assessments and contingency plans
  • •Lead internal discussions related to health-authority meetings and communicate outcomes
  • •Support local regulatory teams with health-authority queries and contribute to process improvement initiatives
Reporting Hierarchy: Reports within Amgen's Global Regulatory Affairs and Safety organization; Collaborates with Global Regulatory Team, Evidence Generation Team, Labeling Working Group, Clinical Study Team and local regulatory teams

* Role responsibilities and qualifications synthesized based on industry benchmark standards.

QUALIFICATIONS & REQUIREMENTS

REQUIRED QUALIFICATIONS

  • Doctorate degree with 6 years of directly related experience OR Master's degree with 8 years of directly related experience OR Bachelor's degree with 10 years of directly related experience
  • Regulatory affairs experience in the pharmaceutical industry
  • Knowledge of regulatory principles, policies, procedures and SOPs
  • Understanding of medicinal-product legislation and registration procedures
  • Understanding of drug development and international regulatory environments
  • Strong oral and written communication skills
  • Strong negotiation and influencing skills

PREFERRED QUALIFICATIONS

  • •8-13 years of experience with a relevant degree and in-depth regulatory experience
  • •In-depth knowledge of legislation and regulations across international/regional countries
  • •Experience with regulatory strategy, labeling and lifecycle management
  • •Experience working with global regulatory teams and cross-border stakeholders

REQUIRED VERIFIED SKILLS

Regulatory strategy
international regulatory affairs
regulatory submissions
CTAs
marketing authorization applications
lifecycle management
regulatory product compliance
RIM
PMCs
agency commitments
labeling strategy
cCDS
health-authority interactions
regulatory research
medicinal-product regulations
drug development

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Health and wellbeing benefits, retirement benefits, employee development and professional growth programs
The posting does not disclose a salary range or specific bonus/equity amount. Compensation should therefore be treated as undisclosed.

ORGANIZATION CONTEXT & CULTURE

Amgen is a global biotechnology and pharmaceutical company focused on developing innovative medicines and advancing treatments for serious diseases.

TEAM SIZE: 27,000+ employees
INDUSTRY: Biotechnology / Pharmaceuticals
Culture: Collaborative, science-driven environment emphasizing regulatory excellence, cross-functional partnership, innovation and patient-focused development.

EXPECTED CAREER ROADMAP

The role can progress toward Senior Manager, Associate Director, Director and broader global regulatory leadership positions, with opportunities to specialize in international strategy, product registration, labeling or lifecycle management.

APPLICATION ADVISORY

Emphasize 8-13 years of regulatory experience and international-market expertise; highlight ownership of CTAs, marketing applications and lifecycle-management submissions; demonstrate regulatory strategy and labeling experience; mention health-authority interaction and negotiation experience; showcase knowledge of regional legislation and ability to work across global and local teams.
RECOMMENDED TRAINING
1/5
Biologics Regulatory Affairs Certification

Biologics Regulatory Affairs Certification

READY TO SUBMIT?

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