Dr.Reddy’s Laboratories Ltd Hiring for Regulatory Affairs Specialist

Regulatory Affairs Specialist

1. Marketing authorization application (MAA’s) – Authoring, review and compilation of dossiers (publishing, validation and submission) for global markets in compliance with country specific guidelines/ requirements.
2. To respond the queries received from partner and respective agency.
3. Regulatory support for tenders, In-Licensing or Out-Licensing.
4. Regulatory review of relevant documents as required for submission/ development.
5. To provide the support during regulatory inspections, as needed.
6. To support for preparation, review and compilation of briefing package for BPD/scientific advice meeting to health authorities (HA).
7. Support in maintaining regulatory systems, databases and any other work related to Regulatory Affairs, as assigned.

Educational qualification: A Bachelor of Science in Pharmacy or Industrial Pharmacy; Pharmacy professional license holder

Minimum work experience: 3 to 5 years of experience in regulatory affairs

Skills & attributes:

• Knowledge of FDA guidelines.
• Proficiency in spoken and written English.
• Proficiency in using a computer and its applications, specifically Google Applications and MS Excel.
• Excellent interpersonal and communication skills.
• Attention to detail and the ability to multi-task and meet strict deadlines.

Benefits Offered

At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.

The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.

Our Work Culture

Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.

Diversity, Equity & Inclusion

At Dr. Reddy’s, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team.  We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background.

For more details, please visit our career website at https://careers.drreddys.com/#!/

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