Wockhardt Ltd
Are you a seasoned regulatory professional with a passion for pharmaceutical excellence and global compliance? Wockhardt Ltd., a global pharmaceutical and biotechnology company, is actively seeking experienced candidates for the position of Manager / Assistant Manager – Regulatory Affairs at its prestigious Wockhardt Research Center in Chhatrapati Sambhajinagar (Aurangabad), Maharashtra.
About Wockhardt
With over 55 years of dedication to saving lives, Wockhardt is a name synonymous with innovation, integrity, and world-class pharmaceutical research. Known for its commitment to healthcare, Wockhardt continues to be a leader in developing life-saving solutions across the globe. The company offers a dynamic and supportive environment where professionals can thrive, contribute to cutting-edge work, and grow their careers.
Position Details
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Job Title: Manager / Assistant Manager – Regulatory Affairs
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Location: Wockhardt Research Center, Chhatrapati Sambhajinagar (Aurangabad), Maharashtra
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Qualification: Master’s Degree in Pharmacy
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Experience: 8–12 years in Regulatory Affairs (specifically for Emerging Market filings)
Key Responsibilities and Skills Required
Ideal candidates should have:
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Expertise in CMC documentation: Ability to author Chemistry, Manufacturing, and Controls (CMC) sections for both drug substances and drug products.
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Regulatory submission experience: Proven capability in handling dossiers and addressing regulatory authority queries across Asia, Africa, MENA, and LATAM regions.
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Format proficiency: Strong command over ACTD/eCTD application formats, change control, and life cycle management.
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Scientific understanding: Deep knowledge of both clinical and non-clinical modules.
This role is critical in ensuring timely and compliant regulatory submissions, thereby supporting Wockhardt’s strategic expansion into emerging markets.
How to Apply
If you meet the criteria and are ready to make a significant impact, send your resume to:
📧 [email protected]
📅 Application Deadline: 31st May 2025
