Are you a seasoned professional in regulatory affairs with a passion for ensuring compliance in the pharmaceutical industry? Dr. Reddy’s Laboratories, a leading global pharmaceutical company, is hiring a Regulatory Affairs Analyst in Hyderabad, Telangana. This full-time, on-site role offers an exciting opportunity to contribute to innovative healthcare solutions, collaborate with European regulatory authorities, and drive regulatory strategies for new product applications. If you have expertise in EU submissions (DCP, MRP, NP) and a knack for detail, this role is your chance to make an impact with a purpose-driven organization committed to “Good Health Can’t Wait.”
Job Responsibilities
As a Regulatory Affairs Analyst at Dr. Reddy’s, you will play a critical role in managing regulatory submissions and ensuring compliance with European Medicines Agency (EMA) guidelines. Key responsibilities include:
- Preparing and submitting new applications for Europe via Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), and National Procedure (NP).
- Reviewing and preparing Module 1 (m1) documentation in alignment with Modules 2-5.
- Ensuring regulatory compliance by preparing product information and reviewing artworks.
- Interacting directly with EU regulatory authorities to address deficiencies and secure timely approvals.
- Providing regulatory guidance to internal teams and international partners.
- Supporting manufacturing sites during regulatory audits.
- Monitoring and following up on product filings for early approvals.
- Developing and revising Standard Operating Procedures (SOPs).
- Building relationships with European health authorities and participating in industry associations to stay updated on regulations.
Qualifications and Skills
To excel in this role, candidates must meet the following requirements:
- Educational Qualification: M.Sc. or M.Pharm.
- Experience: 8-12 years in regulatory affairs, with a focus on European registrations (including Module 1).
- Skills:
- In-depth knowledge of EMA guidelines.
- Proficiency in spoken and written English.
- Expertise in Google Applications and MS Excel.
- Strong interpersonal and communication skills.
- Attention to detail, ability to multitask, and meet strict deadlines.
Benefits of Working at Dr. Reddy’s
Dr. Reddy’s offers a supportive and inclusive work environment with benefits designed to foster career growth and well-being:
- Personalized Learning Programs: Access tailored training to enhance your regulatory expertise.
- Comprehensive Benefits: Enjoy medical coverage, life coverage, family support (maternity/paternity benefits), and relocation assistance.
- Dynamic Work Culture: Thrive in a collaborative, purpose-driven environment that values diversity and innovation.
- Global Impact: Contribute to Dr. Reddy’s mission to reach 1.5 billion+ patients by 2030.
How to Apply
