Regulatory Affairs Executive
1 week ago
Key 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 submissions including INDs/IMPDs, BLA/MAA, CTA, DSUR, Annual Reports, as applicable. 4. Post-approval changes (variations, amendments). 5. Liaise with global regulatory agencies to facilitate product approvals and resolve queries. 6. Collaborate with R&D, Quality, Clinical, and national regulatory teams to ensure regulatory compliance across product lifecycle. 7. Provide regulatory guidance during product development, tech transfer, and clinical trial execution, as appropriate. 8. Monitor and interpret evolving global regulations, guidelines, and industry trends related to product category. 9. Provide interpretive analyses of regulatory guidance, regulations, or directives that impact product(s) or CMC operations. Qualifications: 1. Master’s degree (M.Sc./M.Pharm/M.Tech) in Life Sciences, Biotechnology, Pharmaceutical Sciences, or related discipline. 2. Minimum 5-7 years of regulatory affairs experience, with a strong focus on biologics (including mAbs, biosimilars, vaccines, or novel biologics) in the emerging markets. 3. Solid understanding of ICH guidelines, FDA, EMA, and other emerging market regulatory frameworks. 4. Experience in IND / BLA submissions, and lifecycle management of biological products.
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Regulatory Affairs Manager
4 weeks ago
bangalore, India Ixoreal Biomed Full timeAbout the Company: Shri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts. Title: Manager/Senior Manager- Global Regulatory Affairs Experience: 8–12+ years of Regulatory Affairs experience in Nutraceuticals, Dietary Supplements,...
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Head of Regulatory Affairs
2 days ago
bangalore, India Inventia Healthcare Limited Full timeInventia is into pharmaceutical development and manufacturing from last 40 yrs. We partner with pharma companies to research, develop, manufacture and distribute OSD. Our Manufacturing plant is in Ambernath which produces range of OSD including capsules, tablets, Granules and Pellets. We are there in 45 countries and have 10 plus facility approvals including...
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Regulatory Affairs Associate
3 weeks ago
Bangalore, Karnataka, India Anrgi Tech Full timeJob Title Regulatory Affairs Associate - Authoring Role detailed classification Regulatory Affairs Authoring Job Summary We are seeking highly skilled and experienced Life Sciences LS Regulatory Affairs RA Associate - Authoring to join our LS Practice team The successful candidate will be responsible for LS Regulatory Authoring and or other assigned RA...
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Regulatory Affairs Analyst
4 weeks ago
bangalore, India Varex Imaging Corporation Full timeVarex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the following:...
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Chief Regulatory Affairs Specialist
6 days ago
bangalore, India beBeeRegulatoryAffairs Full timeRegulatory Affairs Expertise:As a key member of our organization, you will be responsible for the authoring, compilation, and submission of regulatory dossiers to global health authorities.Conduct thorough dossier gap analyses to identify document and data gaps.Prepare and convert dossiers in various formats to meet regulatory requirements.Manage the...
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Regulatory Affairs Analyst Ii
4 weeks ago
Bangalore, Karnataka, India Waters Full timeOverview The Regulatory Affairs Specialist II has primary responsibility for provision of In Vitro Diagnostic regulatory support to prepare execute and maintain regulatory filings including change management support of post market requirements and support of outside vendors e g license holders in country representatives Secondary responsibility would be to...
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Regulatory Affairs Specialist
7 days ago
bangalore, India UsefulBI Corporation Full timeAbout UsefulBI: UsefulBI is a leading AI-driven data solutions provider specializing in data engineering, cloud transformations, and AI-powered analytics for Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services. Role Overview: We are seeking a Regulatory Affairs Subject Matter...
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Regulatory Affairs Specialist
1 week ago
bangalore, India UsefulBI Corporation Full timeAbout UsefulBI:UsefulBI is a leading AI-driven data solutions provider specializing in data engineering, cloud transformations, and AI-powered analytics for Fortune 500 companies. We help businesses turn complex data into actionable insights through our innovative products and services.Role Overview:We are seeking a Regulatory Affairs Subject Matter Expert...
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Lead Regulatory Affairs Specialist
3 days ago
Bangalore, Karnataka, India BD Full timeSummary This position independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance This position participates on cross-functional teams leads the development of global regulatory strategies authors regulatory submissions interacts with regulatory agencies notified bodies reviews design control documents...
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Medical Device Regulatory Affairs Manager
1 week ago
bangalore, India ELT Corporate Private Limited Full timeCompany DescriptionELT Corporate Private Limited is an Indian consulting company specializing in regulatory, legal, compliance, business, management, scientific, and technical services.Job Location:- Sector-3, Rohini, Near Rohini West Metro Station, DelhiRole DescriptionThis is a full-time, on-site role based in Delhi for a Medical Device Regulatory Affairs...
