Senior Regulatory Specialist
2 weeks ago
Accountable for development and execution of CMC regulatory strategies, marketing applicationsand Life Cycle Management for biosimilar products.Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolioCoordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar productsCollaboration with partners to develop and execute global regulatory activitiesPlan 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 requirementsProvide regulatory direction on global regulatory requirements to support product developmentEnsure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycleSupport development and execution of clinical/non-clinical strategiesProvide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registrationCollaborate 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 planningEnsure and lead regulatory compliance for biosimilar productsParticipation in regulatory meetings with Health AuthoritiesRegulatory Intelligence:Monitor, assess and implement global regulatory requirements, guidelines, and policies relating to biosimilar productsReview and assess impact of regulatory decisions for competitive productsGenerate and communicate biosimilar intelligence
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Regulatory Specialist
1 month ago
bangalore, India Tag Full timeREGULATORY SPECIALIST At Tag, we help brands stand out and sell more by delivering impactful content, at speed and scale and across channels & geographies. With over fifty years of production experience for some of the world’s biggest brands, we partner with our clients to create work that is efficient, effective and more importantly tells a story. We...
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Regulatory Specialist
1 month ago
bangalore, India Tag Full timeREGULATORY SPECIALIST At Tag, we help brands stand out and sell more by delivering impactful content, at speed and scale and across channels & geographies. With over fifty years of production experience for some of the world’s biggest brands, we partner with our clients to create work that is efficient, effective and more importantly tells a story.We...
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Regulatory Specialist
1 month ago
bangalore, India Tag Full timeREGULATORY SPECIALIST At Tag, we help brands stand out and sell more by delivering impactful content, at speed and scale and across channels & geographies. With over fifty years of production experience for some of the world’s biggest brands, we partner with our clients to create work that is efficient, effective and more importantly tells a story. We...
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Regulatory Specialist
1 month ago
Bangalore Urban, India Tag Full timeREGULATORY SPECIALIST At Tag, we help brands stand out and sell more by delivering impactful content, at speed and scale and across channels & geographies. With over fifty years of production experience for some of the world’s biggest brands, we partner with our clients to create work that is efficient, effective and more importantly tells a story.We...
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Senior regulatory specialist
2 weeks ago
Bangalore, India Biocon Biologics Full timeAccountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products. 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...
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Senior Regulatory Specialist
1 month ago
bangalore, India Biocon Biologics Full timeAccountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products. 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...
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Senior Regulatory Specialist
1 month ago
bangalore, India Biocon Biologics Full timeAccountable for development and execution of CMC regulatory strategies, marketing applicationsand Life Cycle Management for biosimilar products.Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolioCoordination of activities and deliverables provided by other cross-functional teams to...
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National head regulatory affairs
2 weeks ago
Bangalore, India Syngene International Limited Full timeThe Company Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398 R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene’s 4500+ scientists offer both the skills and capacity to...
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Senior Medical Writer
2 weeks ago
Bangalore Metropolitan Area, India Celegence Full timeJob Title: Senior Medical WriterAt Celegence, we are seeking a highly skilled Senior Medical Writer to join our team. As a Senior Medical Writer, you will be responsible for creating high-quality regulatory documents for medical devices across various therapeutic areas.Key Responsibilities:Develop and deliver high-quality regulatory documents compliant with...
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National Head Regulatory Affairs
2 weeks ago
bangalore, India Syngene International Limited Full timeThe CompanySyngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene’s 4500+ scientists offer both the skills and capacity to...
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UK Regulatory Reporting
1 month ago
Bangalore, India State Street Full timeFunctional Job Title                         : Senior Manager (10-12 years)Reports to                                           : Functional Lead for UK...
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Senior Data Engineering Specialist
1 week ago
Bangalore, India Rigel Networks Pvt Ltd Full timeJob Title: Senior Data Engineering SpecialistAbout the Role:We are seeking a highly skilled Senior Data Engineering Specialist to join our team at Rigel Networks Pvt Ltd. As a key member of our data engineering team, you will be responsible for designing, developing, and deploying scalable, real-time, and high-performance cloud data lake solutions.Key...
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Senior Quality Assurance Specialist
5 days ago
Bangalore, India Head pro Full timeJob RequirementsAt Head pro, we are seeking a Senior Quality Assurance Specialist to join our team. The ideal candidate will have 5+ years of experience in manual and automated testing, preferably on the Salesforce and SAP platforms.Key ResponsibilitiesDevelop and execute automation strategies for functional, integration, and regression tests.Collaborate...
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Regulatory Affairs Manager I
5 months ago
Bangalore, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager I Career Level - D Introduction to role: 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 deliverables, including delivery as an individual contributor, if required. The...
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Senior embryologist
2 weeks ago
Bangalore, India Aspire Fertility Center Full timeProfile Overview: We are looking for a Senior Level Embryologist, an enthusiastic individual to join our Embryology Team at Aspire Fertility Center. The successful candidate will have a passion for achieving success as an Embryologist along with a team of fertility and IVF specialists. Qualifications : Degree/Diploma in Clinical Embryology ...
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Senior Verification Specialist
5 days ago
Bangalore, India Excellence and Eminence LLP Full timeAbout the Role:We are seeking a highly skilled Senior Verification Specialist to join our team at Excellence and Eminence LLP. As a key member of our verification team, you will be responsible for owning the execution of verification tests, developing test methods, and ensuring compliance with international standards for medical devices.Key...
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Manager - Clinical Regulatory
4 months ago
Bangalore, India AstraZeneca Full timeJOB TITLE : - CLINICAL REGULATORY CAREER LEVEL: D Lead the way for a new breed of solutions-oriented Regulators Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping drug...
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Formulation Regulatory Affairs
2 weeks ago
bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada MarketLevel - Senior Executive/ Assistant Manager / Deputy Manager - US Market Required Education/Exp: Experience Req.: 3 - 10 yrs.Qualification: - M.Sc. / M. Pharma.ResponsibilitiesHands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.Experience and...
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Senior IT Automation Specialist
5 days ago
Bangalore, India SOA IT Solutions Pvt Ltd Full timeJob Title: Senior IT Automation SpecialistDescription:We are seeking a highly skilled Senior IT Automation Specialist to join our team at SOA IT Solutions Pvt Ltd.Key Responsibilities:Design and develop RPA solutions using UiPath tools, including Robots, Studio, and Orchestrator.Collaborate with business analysts to understand and interpret...
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Formulation Regulatory Affairs
2 weeks ago
Bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada Market Level - Senior Executive/ Assistant Manager / Deputy Manager - US Market Required Education/Exp: Experience Req.: 3 - 10 yrs. Qualification: - M.Sc. / M. Pharma. Responsibilities Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules. ...