Regulatory Affairs Specialist - API
Hyderabad
Regulatory Affairs General
IPDO
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Company Description
Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company committed to accelerating access to affordable and innovative medicines. With a workforce of over 24,000 employees, Dr. Reddy’s operates in 66 countries and strives to reach over 1.5 billion patients globally by 2030. The company fosters a work environment free from discrimination and is dedicated to promoting diversity and inclusion.
Job Description
We are seeking a dynamic and experienced Team Lead in the Global Regulatory Affairs - API team to guide and support regulatory activities, ensuring compliance with regulatory standards across global markets. This position will involve close collaboration with development teams and regulatory agencies, ensuring efficient regulatory submissions and life cycle management.
Roles & Responsibilities
Define regulatory requirements for Drug Master File (DMF) starting materials, intermediates, and APIs, and guide teams for setting specifications.
Provide inputs for control strategies related to PGIs, nitrosamines, and other regulatory needs.
Participate in new product development, phase gate meetings, and integrated product meetings with formulation teams.
Manage global regulatory filings, liaising with regional teams to ensure timely submissions and responses to regulatory queries.
Ensure DMF compliance with regulations in Brazil, China, Japan, Europe, Canada, and Russia, and address deficiencies within stipulated timeframes.
Develop strategies for lifecycle management, alternate vendor development, and operational excellence.
Maintain knowledge of evolving global regulatory requirements and ensure the team is aligned with ICH guidelines.
Conduct team reviews, set performance goals, and guide team members in decision-making and problem-solving.
Qualifications
Educational Qualification: Post Graduate in Organic Chemistry/Pharmaceutical Sciences.
Experience: 10-12 years in API Regulatory Affairs, with a solid understanding of GMP and quality systems.
Technical Skills
In-depth knowledge of global regulatory requirements, product development, manufacturing, and intellectual property management.
Understanding of regulatory guidelines for U.S., Europe, ICH, and other global regions.
Familiarity with GMP/Quality systems and pharmaceutical product value chains.
Behavioral Skills
Strong leadership and collaboration skills.
Excellent communication and interpersonal abilities.
Strong analytical and problem-solving skills.
Additional Information
About the Department
The Integrated Product Development Organisation at Dr. Reddy's leverages deep scientific expertise to deliver accessible and affordable therapies to patients worldwide. With a diverse portfolio of over 1,000 products and robust R&D capabilities, the department integrates API, formulations, clinical research, intellectual property, and regulatory affairs.
Benefits Offered
Dr. Reddy’s offers industry-leading benefits, including relocation support, family benefits (maternity and paternity), medical and life coverage, and opportunities for continuous learning and professional growth.
Our Work Culture
At Dr. Reddy’s, we are driven by the principle of "Good Health Can’t Wait," and we foster a culture of empathy, teamwork, and shared success. We believe that our diverse team, united by a common purpose, creates the foundation for impactful, innovative solutions.
For more details, please visit our career website at Dr. Reddy's Careers.
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