Associate – R&D Regulatory Affairs
Location: Bangalore, India
Employment Type: Full-Time
Industry: Animal Health | Pharmaceutical R&D | Regulatory Affairs
Elanco, a global leader in animal health, is seeking an Associate – R&D Regulatory Affairs to support regulatory strategy, global submissions, and lifecycle management of animal health products. The role involves cross-functional collaboration with R&D, Manufacturing, and Quality teams to ensure timely and compliant regulatory submissions, contributing to the development and commercialization of innovative animal health solutions worldwide.
This role is suited for candidates with 5+ years of experience in global regulatory affairs within pharmaceutical or veterinary industries, with a strong understanding of the drug development lifecycle and regulatory compliance requirements.
Develop and implement global regulatory strategies for the authorization and maintenance of new animal drug registrations across multiple regions.
Support pre-submission preparation and communicate regulatory strategy, key issues, and critical topics to interdisciplinary project teams.
Ensure all required documentation, quality standards, and timelines for global submissions are communicated and tracked according to functional procedures.
Apply regulatory knowledge creatively to support geo-expansion of marketed products, balancing business objectives with compliance requirements.
Partner with internal R&D, Manufacturing, and Quality teams to ensure alignment of regulatory strategy with product development goals.
Build and maintain strong relationships with global regulatory business partners to facilitate smooth submission and approval processes.
Provide regulatory guidance throughout the product lifecycle, including post-approval maintenance and change management.
Maintain up-to-date knowledge of global regulatory guidelines, industry standards, and emerging technical trends.
Ensure adherence to internal SOPs, compliance requirements, and global regulatory frameworks.
Contribute to process improvements to enhance regulatory efficiency and consistency across teams.
Bachelor’s or Master’s degree in Life Sciences, Pharmacy (B.Pharm/M.Pharm), Veterinary Sciences, or related field.
Minimum 5 years of experience in global regulatory affairs, preferably within pharmaceutical or animal health industries.
Strong knowledge of the drug development process and end-to-end lifecycle management of pharmaceutical products.
Demonstrated ability to work effectively in cross-functional teams and manage global regulatory submissions.
Excellent communication, analytical, and problem-solving skills.
Familiarity with regulatory frameworks in multiple geographies.
Experience with innovative approaches in regulatory strategy and submissions.
Strong organizational skills with attention to detail and ability to manage multiple projects concurrently.
Elanco is an Equal Opportunity Employer and complies with all applicable employment legislation, promoting diversity, inclusion, and a workplace free from discrimination based on age, race, color, religion, gender, sexual orientation, gender identity, veteran status, disability, or any other legally protected status.
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