
Senior Biosimilar Development Specialist
7 days ago
Our organization seeks a seasoned professional to develop and implement biosimilar clinical development strategies, oversee clinical trial design and management, and author biosimilar dossiers.
The ideal candidate will be responsible for:
- Designing and implementing comprehensive clinical development plans for biosimilars in the EU and US markets
- Developing and managing clinical protocols for biosimilar products in the EU and US markets
- Overseeing the preparation and submission of clinical trial applications and reports to regulatory authorities in the EU and US
- Authoring and reviewing biologics/biosimilar dossiers for eCTD submissions in the EU and US markets
- Providing RA support for quality management system activities
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Senior Biosimilar Development Specialist
2 days ago
Navi Mumbai, Maharashtra, India beBeeProcess Full time ₹ 8,00,000 - ₹ 12,00,000Job DescriptionWe are seeking a highly skilled and experienced Senior Scientist to join our team.The ideal candidate will have a strong background in biosimilar process development, with expertise in CHO and other mammalian cell lines. They will be responsible for strategizing the development of non-infringing upstream processes, understanding cell lines,...
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Mammalian Biosimilars Program Manager
1 week ago
Mumbai, Maharashtra, India beBeeDevelopment Full time ₹ 15,00,000 - ₹ 20,00,000Mammalian Biosimilars Development LeadWe are seeking a highly experienced professional to lead our Mammalian Biosimilars development program. As a Senior leader in Biotechnology, you will be responsible for developing and implementing long-term strategies for mammalian process development.
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Senior Biosimilar Development Scientist
2 days ago
Mumbai, Maharashtra, India beBeeBioscientist Full time ₹ 1,50,00,000 - ₹ 2,50,00,000Our ideal candidate will play a key role in advancing our biosimilar process development capabilities by leveraging their expertise in Upstream Process Development and Cell Culture.About the RoleWe are seeking a highly skilled Senior Scientist to lead our efforts in developing non-infringing Upstream processes for recombinant molecules using CHO and other...
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Navi Mumbai, Maharashtra, India beBeeDevelopment Full time ₹ 1,50,00,000 - ₹ 2,00,00,000Job SummarySenior Process Development Scientist OpportunityWe are seeking a highly skilled Senior Process Development Scientist to join our team. As a key member of our process development group, you will be responsible for developing non-infringing upstream processes for biosimilar development using CHO and other mammalian cell lines.Key...
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Regulatory Affairs Specialist
12 hours ago
Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000Our organization is seeking a highly skilled professional to fill the role of Regulatory Affairs Specialist - Clinical Trials. This position involves developing strategic plans for biosimilar clinical development, designing and implementing protocols for clinical trials, reviewing and finalizing applications, and preparing regulatory submissions.The ideal...
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Biologics Regulatory Affairs Specialist
4 days ago
Mumbai, Maharashtra, India beBeeBiologics Full time ₹ 1,50,00,000 - ₹ 2,00,00,000Job Title:Biologics Regulatory Affairs Specialist (Clinical Trials)About the Role:We are seeking a skilled Biologics Regulatory Affairs Specialist to oversee the regulatory aspects of our clinical trials for EU and US markets.The ideal candidate will have hands-on experience in developing biosimilar clinical development strategies, clinical trials, and...
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Senior Clinical Development Strategist
18 hours ago
Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000About our organization:We excel in the diabetes and cardio sectors with a presence in over 65 countries.Key Responsibilities:Develop biosimilar clinical development strategies for global markets.Design and review clinical trials for injectables in international markets.Author and review biologics/biosimilar dossiers for regulatory submissions.Provide...
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Regulatory Affairs Specialist
3 days ago
Mumbai, Maharashtra, India beBeeBiologics Full time ₹ 18,00,000 - ₹ 24,50,000Job SummaryWe are seeking an experienced Regulatory Affairs Specialist to join our team in the Biologics department. This role involves developing and executing clinical trials strategies for EU and US markets, with a focus on biosimilars.
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Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 8,00,000 - ₹ 12,00,000Biologics Regulatory Affairs Job OverviewThis role involves strategic planning, execution and delivery of biologics clinical trials across EU and US markets. The ideal candidate will possess expertise in biosimilar clinical development, regulatory affairs, and eCTD submissions.About the RoleThe successful candidate will be responsible for developing and...
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Sr DGM
1 week ago
Mumbai, Maharashtra, India USV PRIVATE LIMITED Full timeUSV Biologics is hiringWe are a 63 year old healthcare company recognized for our leadership in the oral antidiabetic & cardiovascular disease therapeutic segments in India. Our Biologics Program comprises molecular biology, upstream and downstream, analytical and bioanalytical teams and biologics regulatory affairs operating out of Govandi, Mumbai. USV's...