Apply for Manager/Asst. Manager – Regulatory Affairs at Wockhardt Ltd. in Aurangabad. 8–12 yrs experience. High-paying pharma job in emerging market filings.
💼 Wockhardt Ltd. Is Hiring: Manager / Assistant Manager – Regulatory Affairs | Apply by May 31, 2025
Are you an experienced pharmaceutical regulatory professional seeking your next big career move? Wockhardt Ltd., a global leader in pharmaceutical and biotechnology innovation, is hiring for a high-impact position in Regulatory Affairs at its world-class Wockhardt Research Center in Chhatrapati Sambhajinagar (Aurangabad), Maharashtra.
This opportunity is perfect for seasoned candidates with 8–12 years of experience in Regulatory Affairs, especially in handling filings for emerging markets.
🏢 About Wockhardt Ltd.
With over 55 years of excellence in life-saving research, Wockhardt has built a formidable reputation in healthcare, driven by scientific innovation, global regulatory compliance, and sustainable growth. The company operates globally across pharmaceuticals, biotechnology, and active pharmaceutical ingredients (APIs).
Wockhardt offers a collaborative and growth-centric environment, empowering professionals to shape the future of global healthcare.
📌 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: M.Pharm / M.S. in Pharmacy
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Experience: 8 to 12 years in Regulatory Affairs (focused on Emerging Markets)
🛠️ Key Responsibilities:
This is a senior regulatory role requiring expertise in global pharma compliance. You will:
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Prepare, review, and compile CMC documentation (Chemistry, Manufacturing, and Controls) for drug substances and drug products.
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Handle regulatory submissions for Asia, Africa, LATAM, and MENA regions, ensuring compliance and timely delivery.
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Address regulatory authority queries effectively and with scientific justification.
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Ensure documentation is aligned with ACTD and eCTD formats, manage change control, and support life cycle management.
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Contribute to clinical and non-clinical module preparation as needed.
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Collaborate with R&D, Quality Assurance, and Manufacturing teams for smooth regulatory execution.
🧠 Required Skills and Expertise:
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Proven experience in regulatory dossier preparation and handling of emerging market submissions.
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Strong grasp of international regulatory guidelines, including ICH and region-specific protocols.
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Proficiency in document management systems, eCTD publishing tools, and regulatory software platforms.
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Understanding of CMC requirements, stability data interpretation, and risk-based documentation.
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Excellent technical writing, communication, and project management abilities.
🎯 Why Join Wockhardt?
Joining Wockhardt means contributing to healthcare transformation while growing in an internationally recognized company.
✅ Benefits of Working at Wockhardt:
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Attractive compensation and career growth opportunities.
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Work with cross-functional global teams.
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Exposure to regulatory filings across multiple international markets.
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Opportunity to be part of global regulatory strategies and product launches.
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Dynamic and collaborative work culture in state-of-the-art research facilities.
📬 How to Apply:
📧 Email your updated resume to: VKakde@wockhardt.com
🗓️ Application Deadline: 31st May 2025
📝 Subject Line: Application for Regulatory Affairs Manager – Aurangabad.
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Highlight specific market submissions you’ve worked on (e.g., MENA, LATAM).
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Showcase hands-on experience with eCTD tools like Extedo or Lorenz docuBridge.
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Include regulatory authority interactions and successful product approvals.
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Mention any contributions to cross-functional regulatory strategies.
This is more than just a job—it’s an opportunity to contribute to global healthcare compliance and innovation with a company trusted by millions. Wockhardt Ltd. is looking for sharp minds with regulatory vision to support expansion into dynamic international markets.
If you’re ready to take your career to the next level in pharmaceutical regulatory affairs, apply before May 31, 2025, and be part of Wockhardt’s journey of excellence.
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