Associate Director – Regulatory Affairs (CMC & Device)
Location: Hyderabad, India | On-Site | Job ID: R-229125**
Overview
Amgen is seeking an Associate Director of Regulatory Affairs to lead regulatory and operational activities for the CMC & Device Regulatory team based in Amgen India (AIN), Hyderabad. This senior leadership role focuses on regulatory strategy, cross-functional alignment, organizational capability building, and high-quality global regulatory submissions. The position requires a strong blend of people leadership, strategic oversight, and hands-on regulatory expertise.
This opportunity is ideal for experienced regulatory professionals seeking a global impact role within a leading biopharmaceutical organization.
Key Responsibilities
People & Organizational Leadership
Provide inclusive leadership to the CMC & Device Regulatory team in AIN.
Hire, develop, and retain regulatory talent to support long-term organizational capability.
Ensure staff receive structured onboarding, training, and role-based development.
Promote working practices aligned with Amgen’s values, culture, and leadership attributes.
Regulatory & Operational Accountability
Oversee regulatory deliverables including global change assessments, licensure management, submission preparation, and periodic reporting.
Ensure timely, compliant, and high-quality regulatory submissions aligned with global priorities.
Drive consistency across regulatory processes and deliverables to meet global product lifecycle needs.
Partner with senior regulatory leadership to maintain alignment on strategic regulatory directions.
Strategic Alignment & Collaboration
Build collaborative partnerships with global functional leaders and internal stakeholders across geographies.
Serve as a trusted advisor to cross-functional teams, ensuring alignment with business and regulatory objectives.
Lead department planning, performance monitoring, and risk mitigation.
Act as the primary liaison between AIN teams and global CMC & Device Regulatory leadership.
Culture, Compliance & Engagement
Foster a culture of accountability, compliance, inclusion, and integrity.
Ensure adherence to global quality standards and regulatory expectations.
Promote effective communication, transparency, and cross-site engagement.
Leadership Competencies
Strong emotional intelligence and ability to build psychological safety.
Strategic mindset with the ability to align regulatory priorities with business goals.
Clear and persuasive communication across global and functional teams.
Ability to coach, mentor, and develop high-performing teams.
Adaptability to manage competing priorities with resilience.
Commitment to cultural leadership, respect, and values-based decision-making.
Required Experience
Basic Qualifications
Candidates must meet one of the following criteria:
Doctorate degree, plus 5+ years in CMC and/or Device Regulatory Affairs and 2+ years in leadership roles
Master’s degree, plus 6+ years in CMC and/or Device Regulatory Affairs and 4+ years in leadership
Bachelor’s degree, plus 7+ years in CMC and/or Device Regulatory Affairs and 6+ years in leadership
Preferred Qualifications
Proven expertise in CMC and/or Device regulatory activities including global submissions, change management, and lifecycle strategy.
Experience leading cross-functional, matrixed, or global regulatory teams.
Strong understanding of regulatory operations, product development, and global health authority expectations.
Exceptional communication, stakeholder engagement, and decision-making skills.
Demonstrated success in digital transformation, process optimization, or regulatory systems enhancement.
Ability to manage complex priorities while maintaining staff engagement and operational accuracy.
Why Join Amgen?
This role offers the opportunity to lead high-impact regulatory initiatives, collaborate with global partners, and influence regulatory strategy across multiple product modalities. The position is ideal for senior regulatory professionals seeking a leadership pathway within a mission-driven organization focused on advancing patient care.
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
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