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Job Title: Associate Global Development Scientist Director ICareer Level – ELocation: Manyata Tech Park, BangaloreWork Type: HybridTotal years of experience: 10 to 15 yearsIntroduction to role:The Global Development Scientist is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working synergistically and cross functionally...

# **PÆD eller SOSU til botilbud** ***PÆD / SOSU / ERGO til botilbud*** **På Ane Staunings Vej er vi blandede i vores faglige baggrund.** **Vi tror på at en blanding af pædagoger, SOSUér, ergoterapeuter, fysioterapeuter og livserfarne mennesker SAMMEN kan få øje på det hele menneske, som bor i vores botilbud!** **Vi søger derfor bredt og...

Job Title: CMC Regulatory Affairs (Biologics) – Executive to Manager Company: Enzene Biosciences Ltd. Location: Bhosari, Pune (On-site) Employment Type: Full-time Experience: 3–15 years Function: Regulatory Affairs About Enzene Enzene Biosciences is a biopharmaceutical CDMO focused on biosimilars and biologics. Our EU-GMP certified facilities in Pune...

This position, Manager in Global Regulatory Affairs LCM CMC, is a project-facing CMC position supporting life-cycle management. Regulatory ExecutionPrepare, review, and submit post-approval CMC regulatory filings, including:Variations (Type IA/IB/II)Supplements (PAS, CBE-30, CBE-0)Annual reports and renewalsEnsure submissions meet regional requirements...

This position, Manager in Global Regulatory Affairs LCM CMC, is a project-facing CMC position supporting life-cycle management. Regulatory Execution • Prepare, review, and submit post-approval CMC regulatory filings, including:• Variations (Type IA/IB/II) • Supplements (PAS, CBE-30, CBE-0) • Annual reports and renewals • Ensure submissions meet...

Key Responsibilities: Regulatory Submissions & Documentation • Prepare, review, and submit high‑quality regulatory dossiers (IND/IMPD, BLA/MAA, ANDA/Abbreviated MAA where applicable) for global markets including USFDA, EMA. • Ensure accuracy and completeness of CTD/eCTD modules, with strong focus on CMC documentation for biologics/biosimilars. •...

DescriptionKey Responsibilities: Regulatory Submissions & DocumentationPrepare, review, and submit high‑quality regulatory dossiers (IND/IMPD, BLA/MAA, ANDA/Abbreviated MAA where applicable) for global markets including USFDA, EMA.Ensure accuracy and completeness of CTD/eCTD modules, with strong focus on CMC documentation for biologics/biosimilars.Lead...

This position, Manager in Global Regulatory Affairs LCM CMC, is a project-facing CMC position supporting life-cycle management. **Regulatory Execution** - Prepare, review, and submit post-approval CMC regulatory filings, including: - Variations (Type IA/IB/II) - Supplements (PAS, CBE-30, CBE-0) - Annual reports and renewals - Ensure submissions meet...

**Job Title:** CMC Regulatory Affairs (Biologics) – Executive to Manager **Company:** Enzene Biosciences Ltd. **Location:** Bhosari, Pune (On-site) **Employment Type:** Full-time **Experience:** 3–15 years **Function:** Regulatory Affairs **About Enzene** Enzene Biosciences is a biopharmaceutical CDMO focused on biosimilars and biologics. Our...

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About BSV: With over two decades of excellence, Mankind Pharma is now among India's top 5 pharmaceutical companies, powered by a 21,000+ strong workforce. For over five decades, we at Bharat Serums and Vaccines Ltd (part of Mankind Group of Companies) have used scientific resources to develop a range of biological, biotech and pharmaceutical products. We...

Overview Sr. Manager, Statistical Programming Be Part of One Team, One Purpose. At Emmes Group, we’re shaping the future of clinical research—where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence, we’ve led groundbreaking research in cell and gene therapy,...

Title: Associate Director, Biostatistics Business Unit: Global Clinical Development Job Grade: DGM Location: Remote/Hybrid At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own...

Position:  Lead Regulatory BLA and IND ExpertJob Type: CONSULTANTLocation: The role is based in Mumbai, with frequent travel to the US required. Candidates with a valid US VISA will be given preference.Job Summary: -The Lead Regulatory BLA and IND Expert will be responsible for leading the regulatory strategy and submission process for...

Overview Work as a senior programmer on clinical and non-clinical trials; producing complex datasets and outputs to excellent quality whilst adhering to deliverable timelines. Good knowledge of CDISC SDTM and ADaM implementation guidelines; producing, reviewing and updating complex data specifications; creating and debugging complex macros; understanding...

Job Summary : - Lead regulatory strategy and execution for biosimilar BLAs/MAAs with primary ownership of Module 3 (CMC) and Module 5 (clinical). Partner cross-functionally (Process/Analytical Development, Quality, Clinical, PV, Supply Chain) to ensure high-quality dossiers, timely health-authority interactions, and successful approvals and lifecycle...

Regulatory CMC– Biosimilar/BiologicsDescriptionWe are looking for amazing candidates with at least 10 years of Regulatory CMC strategy experience who can lead or support biologics projects for successful outcomes with regulators. Ideal candidates will have acquired the end-to-end knowledge and line-of-sight needed to facilitate a smooth path to licensure...

Title: SME, CDISC & eSubmission Standards Business Unit: Global Clinical Development Job Grade: Manager, G10 Location: Hybrid/Remote At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create...

The Bioassay Analyst will lead the development, optimization, qualification, validation, and routine execution of bioassays and cell-based potency assays for biosimilar products. This role is critical in ensuring analytical similarity, regulatory compliance, and robust characterization of biologics during development, process validation, and commercial...

Title: Associate Director, Biostatistics Business Unit: Global Clinical Development Job Grade: DGM Location: Remote/Hybrid At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own...