Dr. Reddy’s Laboratories is a global pharmaceutical leader with a strong presence in 66 countries. Their core mission is “Good Health Can’t Wait,” and they are dedicated to accelerating access to affordable and innovative medicines. With nearly four decades of experience, Dr. Reddy’s has built a reputation for access, affordability, and innovation. They are committed to sustainable practices, focusing on people, planet, and purpose. They aim to reach over 1.5 billion patients globally by 2030.
Job Description: Regulatory Affairs Analyst
Dr. Reddy’s is seeking a Regulatory Affairs Specialist to oversee the preparation and submission of regulatory dossiers, ensuring compliance and timely approvals, with a focus on the European market. This role is crucial in managing new application submissions for Europe through the Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), and National Procedure (NP).
Key Responsibilities:
- EU Market Expertise: Experience with regulatory submissions, especially for the European market.
- Dossier Preparation: Preparation, review, and submission of new applications via DCP, MRP, and NP for the EU.
- M1 Documentation: Preparation and review of M1 documentation in line with M2-5 documents.
- Artwork and Product Information: Preparation of artworks, including product information, to ensure regulatory compliance.
- Regulatory Authority Interaction: Direct communication with EU regulatory authorities.
- Deficiency Management: Handling deficiencies and providing timely responses to regulatory agencies.
- Communication: Good interpersonal skills and strong written and spoken English for communication with regulatory agencies and internal teams.
- Regulatory Guidance: Provide regulatory guidance and strategies to internal stakeholders.
- Audit Support: Support manufacturing sites during regulatory audits.
- Additional Duties: Performing other tasks and duties assigned by the supervisor.
Additional Responsibilities (Summarized):
- Preparation and submission of regulatory dossiers for Europe.
- Preparation and review of M1 documentation.
- Preparation of artworks and product information.
- Delivering registration goals with minimal supervision.
- Monitoring and follow-up of product filings.
- Participating in industry associations to stay informed about regulations.
- Creating and revising SOPs (Standard Operating Procedures).
- Developing and maintaining relationships with European health authorities.
Qualifications:
- Education: M.Sc or M.Pharm.
- Experience: 8 to 12 years of experience in regulatory affairs, preferably in Europe registrations (including M1).
Skills & Attributes:
- Knowledge: Expertise with EMA guidelines.
- Language: Proficient in spoken and written English.
- Computer Skills: Proficiency in computer applications, including Google Applications and MS Excel.
- Interpersonal Skills: Excellent communication and interpersonal skills.
- Attention to Detail: Ability to multi-task and meet deadlines.
Why Work at Dr. Reddy’s?
Dr. Reddy’s Laboratories offers a supportive and growth-oriented work environment. They are committed to employee development and provide various learning programs. You can expect competitive benefits, including relocation support, family support, learning opportunities, and medical and life coverage.
Dr. Reddy’s fosters a culture of empathy and dynamism. Their core values are centered around their mission of providing “Good Health Can’t Wait.” They believe in creating an environment where individuals with diverse skills collaborate towards a common purpose, driving innovation and success.
