Biologics, Regulatory Affairs- CMC
2 weeks ago
About the Company USV , a top-15 pharmaceutical and biotechnology company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries and is a leading producer of Metformin in India. We specialise in niche product areas across international markets, including Oral Solid Dosages (OSD), sterile products, peptides, biologics, and oncology. USV’s Biologics function is fully integrated to develop high-quality biosimilars that can cater to regulated and other markets. Currently the biosimilar pipeline includes bacterial therapeutic proteins and MAbs (monoclonal antibodies). Explore us at : the RoleFunction: Biologics, Regulatory Affairs Position: Deputy Manager/Manager/Senior Manager - Biologics Regulatory Affairs- CMC Job Location: Govandi (East), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday off), Work from office onlyMust Haves: A minumum of 4 years experience in the below: US & EU registration for Biosimilars Regulatory experience for both drug substance and drug product for USFDA and EMA Intial dossier authoring for modules I - III of CMC for EU & US Biosimilar filing for EU & US Authoring pre approval dossiers for US and EU. MOH query response for both Drug Substance and Drug Product.If from Small Molecules Strong xperience in Small Molecule Injectables registrations for the US market Strong experience in MOH query response for both Drug Substance and Drug Product.Qualifications Desired Qualification: M.Pharm/B.Pharm Desired Work Experience: Candidates having at least 6 - 10 years of experience in US and EU market registrations for Biosimilar therapeutic proteins and Monoclonal Antibodies. Alternatively, candidates having at least 8 - 10 years of experience in Small molecules injectables registrations for the US market with dossier authoring and query response for both drug substance and drug product.Responsibilities Biosimilar Regulated market submissions - US / EU regulatory submission. Biosimilar Dossier Authoring (Drug substance and Drug product), MOH query response and Hands on experience in eCTD submissions. Biosimilar Product Development Strategy for CMC and Clinical development. Review of Quality documents including coordination with Cross functional teams (R&D, QC/QA and Manufacturing). Biosimilar Product Life Cycle Management. RA support for Plant related QMS activities.
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Biologics, Regulatory Affairs- CMC
2 weeks ago
New Delhi, India USV PRIVATE LIMITED Full timeAbout the Company USV , a top-15 pharmaceutical and biotechnology company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries and is a leading producer of Metformin in India. We specialise in niche product areas across international markets, including Oral Solid Dosages (OSD), sterile products, peptides, biologics, and...
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Biologics, Regulatory Affairs- CMC
2 weeks ago
New Delhi, India USV PRIVATE LIMITED Full timeAbout the Company USV , a top-15 pharmaceutical and biotechnology company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries and is a leading producer of Metformin in India. We specialise in niche product areas across international markets, including Oral Solid Dosages (OSD), sterile products, peptides, biologics, and...
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Biologics, Regulatory Affairs- CMC
4 days ago
New Delhi, India USV PRIVATE LIMITED Full timeAbout the CompanyUSV, a top-15 pharmaceutical and biotechnology company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries and is a leading producer of Metformin in India. We specialise in niche product areas across international markets, including Oral Solid Dosages (OSD), sterile products, peptides, biologics, and...
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Manager Global Regulatory Affairs
16 hours ago
New Delhi, India Micro Crispr Pvt. Ltd. Full timeWe are seeking an experiencedRegulatory Affairs professionalto lead and executeglobal regulatory strategiesfor biologic products across multiple development stages. The role involves close collaboration with cross-functional teams and direct engagement with global regulatory authorities to support successful product development and approvals acrossUS, EU,...
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Global Regulatory Affairs
4 weeks ago
New Delhi, India Meril Full timeKey Responsibilities:1. Develop the global regulatory strategies for biologic products across all developmentphases (preclinical to post-marketing) for the (US, EU, and ROW).2. Ensure alignment with business goals and regulatory requirements across the differentregions. (FDA, EMA, emerging markets).3. Prepare, review, and manage high-quality regulatory...
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Regulatory Affairs Executive
4 weeks ago
New Delhi, India Micro Crispr Pvt. Ltd. Full timeKey Responsibilities:1. Develop the global regulatory strategies for biologic products across all development phases (preclinical to post-marketing) for the (US, EU, and ROW).2. Ensure alignment with business goals and regulatory requirements across the different regions. (FDA, EMA, emerging markets).3. Prepare, review, and manage high-quality regulatory...
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Regulatory Affairs Manager
2 weeks ago
New Delhi, India Biocon Biologics Full timeKey Responsibilities: 1. Regulatory Strategy & Planning • Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries. • Ensure alignment with global regulatory strategy and business priorities. • Conduct regulatory risk assessment and provide mitigation...
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Team Lead – Biologic Formulation
6 days ago
New Delhi, India Biocon Biologics Full timeThe Formulation Lead for Biologics formulation will be responsible for leading the development and optimization of formulations for a range of Biologics drug products like mAbs, Bispecifics, ADCs, Fusion MAbs etc. The successful candidate will advise and consult the formulation development teams on designing and developing robust and scalable...
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Team Lead
4 days ago
New Delhi, India Biocon Biologics Full timeThe Formulation Lead for Biologics formulation will be responsible for leading the developmentand optimization of formulations for a range of Biologics drug products like mAbs, Bispecifics, ADCs, Fusion MAbs etc. The successful candidate will advise and consult the formulation development teams on designing and developing robust and scalable formulations.Key...
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Team Lead
4 days ago
New Delhi, India Biocon Biologics Full timeThe Formulation Lead for Biologics formulation will be responsible for leading the developmentand optimization of formulations for a range of Biologics drug products like mAbs, Bispecifics, ADCs, Fusion MAbs etc. The successful candidate will advise and consult the formulation development teams on designing and developing robust and scalable formulations.Key...
