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Manager RA
Elanco
Mumbai, IND
Full-time
Senior · 8+ years experience
Onsite
Discovered 2 weeks ago
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At Elanco (NYSE: ELAN) – it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Your Role: Regulatory Affairs Lead - South Asia
- As a Regulatory Affairs Lead, you will spearhead the registration and lifecycle management of Elanco’s diverse portfolio across India and South Asia. In this role, you will navigate complex regulatory landscapes to ensure our products reach the animals and owners who need them most while maintaining 100% compliance.
Your Responsibilities
- Lead end-to-end registration for new drugs, biologicals, and pharmaceuticals across India and South Asian markets (Sri Lanka, Bangladesh, and Nepal).
- Compile and review high-quality Chemistry, Manufacturing, and Controls (CMC) data, ensuring all registration files meet rigorous international and local standards.
- Drive operational efficiency through expert use of online portals such as SUGAM and NSWS to ensure seamless submissions and rapid approvals.
- Provide critical Pharmacovigilance (PV) stewardship for the region, overseeing PSUR filings and AEPC reporting while maintaining strict SOP compliance.
- Build and maintain strong professional relationships with health authorities including CDSCO, State FDAs, DAHD, and AQCS.
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