Manager RA
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About the role
Elanco develops animal health products and services to prevent and treat disease in farm animals and pets. The Regulatory Affairs Lead will manage product registrations, lifecycle compliance, submissions, and pharmacovigilance across India and South Asia.
What you'll do
- Lead product registrations across India and South Asian markets
- Compile and review chemistry, manufacturing, and controls data
- Submit regulatory files through SUGAM and NSWS portals
- Oversee PSUR filings and adverse event reporting
- Maintain relationships with health authorities
- Coordinate artwork, labelling, and certification compliance
Skills
Must have
- Regulatory affairs
- Regulatory submissions
- Pharmacovigilance
- Drug regulatory compliance
- Drugs and cosmetics act
- Cdsco guidelines
Nice to have
- Artwork compliance
- Labelling compliance
- Gmp compliance
Tools
- Sugam
- Nsws
Who it's for
- Education
- Bachelor's degree
- Degree
- veterinary medicine, pharmacy, life sciences
- Experience
- 8+ years
- Domain
- animal health pharmaceuticals
About Elanco
Elanco has 18 open roles in Bangalore, at Elanco Innovation and Alliance Centre India LLP. See every Elanco role.
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