Manager clinical regulatory affairs
4 weeks ago
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. 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 • Regulatory Strategy and Execution • Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements • Provide regulatory direction on global regulatory requirements to support product development • Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle • Support development and execution of clinical/non-clinical strategies • Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration • Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans • With minimal supervision, participate in development of risk management and contingency planning • Ensure and lead regulatory compliance for biosimilar products • Participation in regulatory meetings with Health Authorities Regulatory Intelligence: • Monitor, assess and implement global regulatory requirements, guidelines, and policies relating to biosimilar products • Review and assess impact of regulatory decisions for competitive products • Generate and communicate biosimilar intelligence Collaboration: • Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products • Escalate regulatory issues, progress, and metrics to the GRA Biosimilars function Knowledge and Skills • Comprehensive understanding of Regulatory activities • Regulatory experience with product filings • Familiarity with project management requirements • Ability to understand and communicate scientific CMC information • Ability to communicate regulatory strategies and requirements to ensure expectations are understood DMF preparation and updates Briefing book preparation for scientific advices and related administrative tasks leading to submission
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Regulatory Affairs Manager
12 hours ago
bangalore, 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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Scientific and Regulatory Affairs Consultant
2 weeks ago
Bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs - for Peptide products or Injectables Required Education/Ex p: Experience Req.: 8 - 12 yrs. Key Role- Formulation Regulatory Affairs for Peptide products or Injectables Drafting controlled correspondences, pre-development meetings and scientific advices for seeking regulatory feedback on various topics from different...
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Regulatory Affairs Manager I
3 weeks ago
Bangalore, Karnataka, India AstraZeneca Full timeJob Title Regulatory Affairs Manager I Global Career Level D1 Introduction to role Are you ready to be part of a team that transforms drug development strategies into reality The Regulatory Affairs Manager I is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning coordination and execution of assigned...
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Senior Manager/Director of Regulatory Affairs
10 hours ago
Bangalore, India Biocon Biologics Full timeRegulatory 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 strategies during planning and...
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Regulatory Affairs Specialist
2 weeks ago
Bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs - for Peptide products or Injectables Level - Deputy Manager/ Associate Manager Required Education/Ex p: Experience Req.: 8 - 12 yrs. Qualification: - M. Pharma / M.Sc. Key Role- Formulation Regulatory Affairs for Peptide products or Injectables Responsibiliti es: Drafting controlled correspondences, pre-development...
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Regulatory Affairs Specialist –
12 hours ago
bangalore, India vueverse. Full timeKey Responsibilities: Regulatory Submissions & Compliance Author, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and others. Conduct dossier gap analysis to identify document and data gaps across all CTD modules (1–5). Convert and prepare dossiers in...
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bangalore, India Tek Support Full timeJob Title: Senior Trainer – Regulatory Affairs (Medical Devices)Location: RemoteJob Type: Part-TimeJob Summary:We are seeking an experienced Regulatory Affairs Trainer with deep expertise in medical device regulations and compliance to design and deliver advanced training programs for professionals in the medical device industry. The ideal candidate will...
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Regulatory Affairs Specialist
1 week ago
bangalore district, India Biocon Full timeRole - Formulation Regulatory Affairs - for Peptide products or Injectables Level - Deputy Manager/ Associate Manager Required Education/Ex p: Experience Req.: 8 - 12 yrs. Qualification: - M. Pharma / M.Sc. Key Role- Formulation Regulatory Affairs for Peptide products or Injectables Responsibiliti es: Drafting controlled correspondences, pre-development...
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Regulatory Affairs Specialist –
2 days ago
bangalore, India vueverse. Full timeKey Responsibilities:Regulatory Submissions & ComplianceAuthor, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and others.Conduct dossier gap analysis to identify document and data gaps across all CTD modules (1–5).Convert and prepare dossiers in...
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Regulatory Affairs Specialist
4 days ago
bangalore, India Concept Medical Full timeAbout Us:Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the...
