Dr. Reddy’s Laboratories is a global pharmaceutical company based in India, recognized for its contributions to providing affordable and innovative medicines to millions of patients worldwide. Since its founding in 1984, the company has expanded its presence across 66 countries and employs over 24,000 people. Dr. Reddy’s focus is on accelerating access to healthcare solutions by leveraging deep scientific expertise and a commitment to sustainability. The company prides itself on its inclusive work culture, innovation, and long-term vision to reach 1.5 billion patients by 2030.
Responsibilities in the Job
As a Regulatory Affairs Analyst at Dr. Reddy’s Laboratories, you will play a key role in ensuring the company’s compliance with various regulatory requirements. The main responsibilities include:
- Regulatory Dossier Preparation: Develop and prepare regulatory dossiers for pharmaceutical or medical device products for the Chinese (CN) and Taiwanese (TW) markets.
- Regulatory Strategy Implementation: Collaborate in implementing regulatory strategies for new and existing products, ensuring compliance during new product development, filings, and launches.
- Collaboration with Cross-Functional Teams: Work closely with manufacturing sites, CMOs, and ILOS partners to ensure smooth dossier preparation and address any open points or deficiencies before submission.
- Deficiency Response: Understand and address regulatory deficiencies, preparing and coordinating timely responses with internal teams.
- Updating Stakeholders: Keep relevant stakeholders informed about regulatory updates, changes in guidelines, and their potential impact on product pipelines.
- Maintaining Regulatory Documentation: Ensure the accurate archival of regulatory information and participate in regulatory inspections and audits as required.
- Continuous Improvement: Contribute to the improvement of regulatory processes and procedures.
Qualifications
To qualify for the Regulatory Affairs Analyst position at Dr. Reddy’s Laboratories, candidates should possess:
- Educational Qualification: M. Pharm (Master of Pharmacy) degree, Msc
- Years of Experience: 4 to 6 years of experience in regulatory affairs or pharmaceutical development.
- Mandatory Skills:
- Knowledge of FDA, NMPA, and EMA guidelines.
- Strong communication skills (written, oral, and presentation).
- Proficiency in regulatory documentation and technical writing.
- Understanding of compliance management principles.
- Proficiency in Microsoft Office Suite and regulatory information management systems.
- Additional Skills:
- Ability to work effectively in a dynamic and fast-paced environment.
- Willingness to travel occasionally for regulatory inspections or training.