Dr. Reddy’s Laboratories is a globally recognized multinational pharmaceutical company committed to accelerating access to affordable and innovative medicines. With a presence in 66 countries and a workforce of over 24,000 employees, Dr. Reddy’s has been a pioneer in the pharmaceutical industry since 1984.
The company focuses on deep science, progressive people practices, and strong corporate governance to deliver high-quality healthcare solutions. Their mission is to reach 1.5 billion+ patients by 2030 through sustainable and purpose-driven initiatives.
Dr. Reddy’s fosters an inclusive work environment, promoting diversity and equal opportunity for all employees.
Job Description: Regulatory Affairs Specialist – API
Key Responsibilities:
- Define regulatory requirements for Drug Master File (DMF) submissions globally.
- Guide teams on specifications for starting materials, intermediates, and APIs in compliance with global regulations.
- Ensure regulatory filings (US, Europe, China, Japan, Brazil, Canada, Russia) meet scorecard commitments.
- Review and respond to deficiency letters from regulatory agencies promptly.
- Develop submission strategies for alternate synthetic processes and manufacturing sites.
- Collaborate with Product Delivery Managers to ensure smooth execution of regulatory filings.
- Monitor life cycle management activities, including process improvements and alternate vendor approvals.
- Stay updated with ICH guidelines, pharmacopeias, and regional regulatory changes.
- Train and mentor team members on evolving global regulatory requirements.
Skills & Qualifications:
- Educational Qualification: Postgraduate in Organic Chemistry/Pharmaceutical Sciences.
- Experience: 10-12 years in API Regulatory Affairs with expertise in GMP & Quality Systems.
- Technical Skills:
- In-depth knowledge of USFDA, EMA, China NMPA, Japan PMDA, ANVISA (Brazil) regulations.
- Understanding of Generic Drug User Fee Amendments (GDUFA).
- Familiarity with pharmaceutical IP and quality compliance.
- Behavioral Skills:
- Strong communication, leadership, and problem-solving abilities.
- Ability to collaborate across teams and influence decision-making.
Why Join Dr. Reddy’s?
- Career Growth: Personalized learning programs for professional development.
- Employee Benefits:
- Medical & life insurance for employees and families.
- Maternity & paternity support.
- Relocation assistance.
- Work Culture: A dynamic, inclusive environment fostering innovation and teamwork.
How to Apply?
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