Senior Associate – R&D (Regulatory Affairs)
Location: Bangalore, India
Employment Type: Full-Time
Industry: Animal Health | Pharmaceutical R&D | Global Regulatory Affairs
Elanco, a global leader in animal health, is hiring a Senior Associate – R&D (Regulatory Affairs) to support and execute global regulatory strategies for animal health products. This role plays a critical part in ensuring successful authorization, maintenance, and lifecycle management of veterinary medicinal products across global markets. The position requires close collaboration with R&D, Manufacturing, and Quality teams to deliver compliant, timely, and business-aligned regulatory submissions.
This opportunity is ideal for professionals with 5+ years of experience in Global Regulatory Affairs who are seeking to work in a globally integrated R&D environment within the animal health and pharmaceutical sector.
Support the development and execution of global regulatory strategies for new and existing animal health products.
Manage regulatory activities related to authorization, registration maintenance, and post-approval lifecycle management across multiple geographies.
Demonstrate strong understanding of the drug development process, including end-to-end lifecycle management (LCM) of complex pharmaceutical dosage forms.
Contribute to pre-submission planning and preparation, ensuring alignment with global regulatory strategies.
Coordinate preparation, review, and tracking of regulatory submission documentation, ensuring compliance with internal procedures, timelines, and quality standards.
Proactively communicate regulatory risks, key issues, and strategic considerations to cross-functional project teams throughout the product lifecycle.
Work closely with R&D, Quality, Manufacturing, and other internal stakeholders to align regulatory requirements with development and commercialization objectives.
Maintain effective partnerships with global regulatory agencies and external regulatory business partners.
Stay current with evolving global regulatory guidelines, regional requirements, and emerging technical and scientific trends.
Contribute to continuous improvement of regulatory processes, tools, and best practices within the R&D organization.
Bachelor’s or Master’s degree in Science, Pharmacy (B.Pharm/M.Pharm), Veterinary Sciences, or a related discipline.
Minimum 5 years of experience in Global Regulatory Affairs within pharmaceutical, veterinary, or animal health industries.
Proven experience with regulatory submissions and lifecycle management for pharmaceutical or veterinary medicinal products.
Strong understanding of global regulatory frameworks and compliance requirements.
Excellent communication, documentation, and stakeholder management skills.
Experience supporting regulatory strategies for geo-expansion of marketed products.
Ability to balance regulatory compliance with business objectives through innovative regulatory approaches.
Strong organizational skills with the ability to manage multiple submissions and priorities simultaneously.
Experience working in global, cross-functional project teams.
Elanco is an Equal Opportunity and Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status.
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