Regulatory Affairs Specialist

1. Marketing authorization application (MAAs) - 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.

Qualifications :

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.

Additional Information :

Benefits Offered

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

The benefits you will enjoy at Dr. Reddys 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. Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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. Reddys 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 Work :

No

Employment Type :

Full-time