Senior Executive IRA

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Job Title:

Sr. Executive – Regulatory & Business Continuity - India

Business Unit:

R&D1 Regulatory Affairs

Job Grade

G11B

Location :

Vadodara

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At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?� As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Job � � Job Description

• Responsible for all activity related to loan license.

• Filling new loan licence application
• Arrange for timely response to the raised queries
• Filling renewal/retentions within time line.
• To support the joint inspections/ FDA audits for grant of loan licences.�

• Responsible for all activity related to manufacturing license for Gujarat location.

-� � � � � � � � � � � � � Filling new licence application

-� � � � � � � � � � � � � Arrange for timely response to the raised queries

-� � � � � � � � � � � � � Filling renewal/retentions within time line.

-� � � � � � � � � � � � � To support the joint inspections/ FDA audits for grant of new/retention of manufacturing licences.

• Responsible for all the activity related to WHO-GMP applications for Gujarat locations and loan locations.

• Filling renewal/retention of WHO-GMP certificates.
• Filling addition of new products in existing WHO-GMP certificate
• To support the joint inspections.
• Arrange for compliance submission for the raised observations.

• Responsible for all the activates related to Written Confirmation application.
• Preparation and review of export NOC, Form-29 and CoPP applications for other than Gujarat locations.
• Preparation and review miscellaneous applications (e.g. Free Sale Certificate, Manufacturing and market Standing certificate, narcotic and psychotropic substances destruction certificate etc).
• To extend support to the all plant locations as and when required for the applications submissions and approvals.�

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Travel Estimate

NA

Job Requirements

Educational Qualification

Qualification : M.Pharm

Experience

Tenure: � Minimum 8 years of relevant experience

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

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