
Biosimilar Product Regulatory Lead
1 week ago
The Regulatory Affairs Specialist plays a pivotal role in ensuring compliance with regional regulations, driving the lifecycle management of biosimilar products, and spearheading submissions for primary filings and variations.
This role requires a high degree of expertise in regulatory affairs, strategic planning, and stakeholder engagement. The incumbent will work closely with cross-functional teams to develop and implement regulatory strategies, prepare and submit dossiers, and evaluate and implement regulatory changes impacting product lifecycle.
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Biosimilar Product Regulatory Specialist
2 weeks ago
Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 1,00,00,000 - ₹ 1,80,00,000**Regulatory Affairs Specialist: Emerging Markets Role**We are seeking a skilled Regulatory Affairs Specialist to join our team in managing regulatory activities for biosimilar products in the emerging market, with a strong focus on LATAM region.This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and...
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Biosimilar Product Compliance Expert
3 days ago
Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 18,00,000 - ₹ 24,00,000Job Summary:The Regulatory Affairs Specialist role is a critical position within the pharmaceutical industry, responsible for ensuring compliance with regional regulations and managing regulatory activities for biosimilar products in emerging markets.This includes developing and implementing regulatory strategies, preparing and submitting dossiers for...
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Bengaluru, Karnataka, India beBeeBiosimilar Full time ₹ 6,00,000 - ₹ 8,00,000Cost Optimization and Biosimilar Development ExpertWe are seeking a highly skilled professional to join our team as a Cost Optimization and Biosimilar Development Expert. This individual will be responsible for leading successful cost reduction initiatives and developing expertise in biosimilar development, manufacturing processes, and regulatory...
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Regulatory Affairs Specialist
2 days ago
Bengaluru, Karnataka, India Biocon Biologics Limited Full time ₹ 5,00,000 - ₹ 8,00,000 per yearJob 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•...
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Chief Regulatory Compliance Officer
6 days ago
Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 8,00,000 - ₹ 12,00,000**Job Summary:**We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to join our Global Regulatory team.In this role, you will be responsible for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products.Plan and manage development of high quality regulatory...
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Senior Regulatory Affairs Manager
1 week ago
Bengaluru, Karnataka, India Biocon Biologics Limited Full time US$ 90,000 - US$ 1,20,000 per yearJOB DESCRIPTIONWe are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Global Regulatory team. In this role, you will be responsible for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products.RESPONSIBILITIES:• Plan and manage development of high...
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Senior Regulatory Affairs Specialist
1 week ago
Bengaluru, Karnataka, India Biocon Biologics Full time US$ 80,000 - US$ 1,20,000 per yearWe are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Global Regulatory team. In this role, you will be responsible for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products.RESPONSIBILITIES:• Plan and manage development of high quality regulatory...
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Senior Regulatory Affairs Specialist
6 days ago
Bengaluru, Karnataka, India Biocon Biologics Full timeWe are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Global Regulatory team. In this role, you will be responsible for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products. RESPONSIBILITIES: • Plan and manage development of high quality...
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Strategic Regulatory Compliance Specialist
1 week ago
Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 90,00,000 - ₹ 1,20,00,000We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our team.Key ResponsibilitiesPlan 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...
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Senior Regulatory Affairs Expert
6 days ago
Bengaluru, Karnataka, India beBeeExpert Full time ₹ 1,20,00,000 - ₹ 2,50,00,000Regulatory Affairs SpecialistWe are seeking a skilled professional to lead our regulatory efforts. In this role, you will be responsible for developing and implementing regulatory strategies to support product development.Key Responsibilities:Plan and manage the development of high-quality regulatory documents, including briefing documents, CTAs, IND/IMPD,...