UMEDICA Laboratories
1 week ago
About UMEDICA:UMEDICA Laboratories is an industry leader in the development, manufacturing, and export of high-quality pharmaceutical formulations. With decades of operational excellence and approvals from major global regulatory bodies (USFDA, EU, PIC/S), UMEDICA is expanding its Regulatory Affairs leadership team to support global growth.We are looking for an experienced Senior Manager - Regulatory Affairs (US Markets) to spearhead regulatory strategy, submissions, and compliance for the US portfolio.Key Responsibilities:Regulatory Strategy & Leadership:- Lead regulatory strategies for the US market across development, filing, and lifecycle stages.- Drive end-to-end ANDA/NDA submissions, ensuring compliance with USFDA expectations.- Lead post-approval submissions (PAS, CBE) and annual reporting activities.- Provide expert regulatory guidance for complex formulations, including injectables and liquid dosage forms.FDA Interactions:- Lead FDA meeting preparations-Type B/C meetings, briefing packages, and follow-up communications.- Handle controlled correspondences, addressing regulatory queries and clarifying development pathways.Cross-functional & External Collaboration:- Partner with R&D, Quality, Manufacturing, and Clinical teams to align regulatory requirements with development goals.- Represent Regulatory Affairs in internal meetings and external regulatory interactions.- Support commercial launch readiness and lifecycle management activities.Team Leadership:- Lead, mentor, and develop a team of regulatory professionals.- Oversee workload planning, performance management, and capability building.Qualifications & Experience:- 13-15 years of strong experience in US Regulatory Affairs with proven success in ANDA/NDA filings.- Hands-on experience with FDA meetings, controlled correspondence, and complex regulatory negotiations.- Strong understanding of US drug development, cGMP regulations, and USFDA submission pathways.- Excellent leadership, communication, and stakeholder management skills (ref:iimjobs.com)
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UMEDICA Laboratories
1 week ago
Mumbai, India UMEDICA LABORATORIES PRIVATE LIMITED Full timeUMEDICAUMEDICA Laboratories is a vertically integrated pharmaceutical company with strong global presence across 85+ countries.With state-of-the-art, globally accredited manufacturing facilities (USFDA, EU, PIC/S), UMEDICA continues to grow through innovation, quality excellence, and regulatory expertise.As part of our expansion, we are seeking a highly...
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Navi Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA. UMEDICA was...
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Navi Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA. UMEDICA was...
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navi mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA. UMEDICA was...
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Manager / Sr Manager Regulatory Affairs– US Markets
18 hours ago
navi mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA. UMEDICA was...
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Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
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Navi Mumbai, Maharashtra, India Umedica Laboratories Private Limited Full time ₹ 12,00,000 - ₹ 36,00,000 per yearUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
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Navi Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
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Navi Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
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Navi Mumbai, India Umedica Laboratories Private Limited Full timeUMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...
