Associate Director Biostatistics Novartis

6.0 - 10.0 years

0 Lacs

hyderabad, telangana

On-site

You will be responsible for providing advanced expert support and functional leadership to ensure scientific integrity and validity for clinical development, early development, and/or research projects. Your role will involve developing and applying biostatistics and programming methods to ensure valid conclusions. Additionally, you will provide statistical support for regulatory submissions, including planning, analysis, and reporting of clinical safety and efficacy summaries. You may also provide statistical support in research or other R&D areas. Independently, you will lead special projects focusing on innovative tools and systems, supporting the Director of Clinical Data Standards. **Ke...

Posted 3 weeks ago

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Regulatory Affairs Specialist Biocon Biologics

0.0 years

0 Lacs

bengaluru, karnataka, india

On-site

Job Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects. Responsible for: Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products Collaboration with partners to develop and execute global regulatory activities DMF preparations, review of changes and routine updates to Global Regulatory Agencies Dossier preparation...

Posted 1 month ago

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Assistant Manager - Regulatory Affairs IMPRONICS DIGITECH PRIVATE LIMITED

3.0 - 7.0 years

0 Lacs

maharashtra

On-site

The ideal candidate for this role should possess a minimum education qualification of M. Pharmacy. You will be responsible for handling regulatory activities such as CTD dossier preparation, query resolution, and ensuring compliance with ICH guidelines and current regulatory standards. Your primary market focus will be on the Africa market, specifically in regions like Zazibona, South Africa, East Africa (Kenya, Tanzania, Ethiopia, etc.), and FWA. Your key responsibilities will include: - Preparation and submission of new dossiers - Conducting gap analysis of dossiers for completeness - Compiling dossiers in eCTD format for submission to various regulatory authorities - Coordinating dossier ...

Posted 2 months ago

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Manager - Regulatory CMC SUN PHARMA

5.0 - 10.0 years

0 Lacs

haryana

On-site

The position of Manager is currently open within the Global Regulatory Affairs Specialty Pharma department. The ideal candidate should hold a M. Pharm education and possess 5-10+ years of hands-on experience in regulatory affairs. The preferred job location is Gurgaon, with Baroda and Mumbai as alternative options. As a Regulatory CMC Product Lead, you will be responsible for providing CMC Regulatory leadership within Regulatory and on cross-functional teams for branded products being developed for markets such as the US, EU, and Canada. Your key responsibilities will include ensuring product lifecycle management through timely submission of annual reports and supplements, as well as deliver...

Posted 3 months ago

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