Biosimilar Product Compliance Expert

Cost 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...

Job DescriptionThe 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....

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where...

**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...

About the CompanyBiocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar...

**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...

We 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...

**Job Title:** Senior Regulatory ManagerAs a seasoned professional in the field of Regulatory Affairs, we are seeking an individual with extensive experience in biologics/biosimilars registration across Emerging Markets. This role is responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with...

Regulatory 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,...

Regulatory Affairs ProfessionalWe are seeking a highly skilled and experienced Regulatory Affairs professional to join our team in Bengaluru, India.The ideal candidate will have hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions.Prepare, review, and submit regulatory dossiers...