Manager – Regulatory Promotions Operations
Location: Hyderabad, India
Job ID: R-219144
Posted On: July 01, 2025
Employment Type: Full-Time | On-Site
About Amgen:
Amgen is a biotechnology pioneer committed to transforming lives through science and innovation. For over four decades, Amgen has led the way in discovering, developing, and delivering therapies for patients suffering from serious diseases. With a global focus on Oncology, Inflammation, General Medicine, and Rare Disease, Amgen remains at the forefront of scientific advancement.
Position Overview:
The Manager of Regulatory Promotions Operations is a leadership position supporting Amgen’s US-Based Regulatory Promotions and Material Compliance (RPMC) team. This role manages a team of 10 Associates and Sr. Associates at the AIN site, responsible for regulatory promotional operations and compliance for the US Business Operations (USBO) region. The manager will lead critical services including FDA 2253 submission preparation, digital asset archiving, label updates, and registry audit responses—ensuring timely and compliant delivery of all activities in line with USBO timelines (e.g., product launches, new indications).
Key Responsibilities:
Team Leadership:
Lead, manage, and mentor a team of 10 regulatory staff.
Conduct mid-term and annual performance reviews and define yearly goals.
Manage team performance, onboarding, offboarding, and training processes.
Operational Management:
Oversee resource allocation and ensure Service Level Agreements (SLAs) are consistently met or exceeded.
Maintain business continuity and optimize workforce planning based on demand from US Business Operations.
Process & Compliance Oversight:
Standardize operational procedures across services to maintain consistency and compliance.
Ensure execution of 2253 packages, pre-clearance content, and global promotional content archiving.
Training & Development:
Train team members on new procedures, system functions (including Veeva PromoMats), and compliance updates.
Promote continuous learning and performance development across the team.
Strategic & Project Support:
Provide project management support for improvement initiatives.
Collaborate with senior leaders to identify skill gaps and implement performance improvement strategies.
Foster a high-performance culture focused on regulatory excellence.
Required Skills and Experience:
Essential:
Strong leadership experience in managing multi-service teams.
Expertise in Regulatory Promotions, MLR review processes, and Veeva PromoMats.
Excellent communication, problem-solving, and change management skills.
Proven ability to coach, mentor, and manage team performance effectively.
Strong understanding of regulatory compliance practices within the pharmaceutical space.
Preferred:
Deep understanding of US FDA promotional material compliance.
Experience working with digital asset management, content review workflows, and audit responses.
Prior work in a Regulatory Promotions or Marketing Operations team.
Qualifications:
Master’s degree and 4 years of relevant experience
OR
Bachelor’s degree and 6 years of relevant experience
OR
Associate’s degree and 10 years of relevant experience
Preferred: Bachelor's or Master’s degree with experience in Regulatory Promotions or Marketing Operations.
Estimated Salary: ₹50–70 LPA (based on role complexity and industry benchmarks)
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