
Regulatory Affairs Manager
7 days ago
At Biocon Biologics, we are seeking a highly skilled and experienced Manager Global Regulatory Affairs to join our team.
Key Responsibilities:- Develop and execute global regulatory strategies for biosimilar products, ensuring compliance with regulatory requirements and approved filing plans.
- Collaborate with cross-functional teams to support product development, approval, and long-term planning.
- Provide regulatory direction on global regulatory requirements and ensure all filings are maintained per regulatory requirements.
- Support development and execution of clinical/non-clinical strategies and provide review, input, and regulatory advice into study concept CMC documents.
- Minimum 5 years of experience in regulatory affairs, with a focus on biosimilars or injectables.
- Strong knowledge of global regulatory requirements and experience with regulatory submissions.
- Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.
- A dynamic and challenging work environment with opportunities for growth and development.
- A competitive salary and benefits package.
- The chance to work with a leading biotechnology company and contribute to the development of innovative biosimilar products.
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Regulatory Affairs Manager
6 days ago
Bengaluru, Karnataka, India Biocon Biologics Full timeJob Title: Manager Global Regulatory AffairsAt Biocon Biologics, we are seeking a highly skilled and experienced Manager Global Regulatory Affairs to join our team.Key Responsibilities:Develop and execute global regulatory strategies for biosimilar products, ensuring compliance with regulatory requirements and industry standards.Collaborate with...
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Regulatory Affairs Director
7 days ago
Bengaluru, Karnataka, India Parexel Full timeRegulatory Affairs ManagerAt Parexel, we're committed to delivering exceptional results for our clients. As a Regulatory Affairs Manager, you'll play a critical role in ensuring the success of our clinical trials.Key Responsibilities:Regulatory Submissions: Lead the preparation and submission of regulatory documents for clinical trials, ensuring compliance...
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Regulatory Affairs Specialist
4 days ago
Bengaluru, Karnataka, India Parexel Full timeRegulatory Affairs SpecialistAt Parexel, we're seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for managing the regulatory life cycle of drug products, from pre-approval to post-approval. Your expertise will be essential in ensuring compliance with regional regulatory...
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Regulatory Affairs Specialist
7 days ago
Bengaluru, Karnataka, India Parexel Full timeUnlock Your Potential as a Regulatory Affairs ConsultantAbout the Role:We are seeking a highly skilled Regulatory Affairs Consultant to join our team at Parexel. As a key member of our regulatory team, you will be responsible for providing expert guidance on regulatory matters related to drug products, including pre and post-approval life cycle...
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Regulatory Affairs Specialist
7 days ago
Bengaluru, Karnataka, India Baxter Full timeTransforming Healthcare through Regulatory ExcellenceBaxter is a leading global healthcare company that has been pioneering medical innovations for over 85 years. Our mission is to save and sustain lives, and we're looking for talented individuals to join our team in Regulatory Affairs.As a Regulatory Affairs Specialist, you will play a critical role in...
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Regulatory Affairs Specialist
2 days ago
Bengaluru, Karnataka, India ResMed Full timeThe Regulatory Affairs function at ResMed plays a crucial role in ensuring compliance with regulatory frameworks and delivering optimal regulatory strategies for portfolio planning, active regulatory intelligence, and excellence in execution.Key Responsibilities:Support and maintain various internal and government databases relevant to ResMed's...
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Regulatory Affairs Specialist
7 days ago
Bengaluru, Karnataka, India Parexel Full timeJob Description:Unlock Your Potential in Regulatory AffairsParexel is seeking a highly skilled Regulatory Affairs Consultant to join our team. As a key member of our regulatory team, you will play a critical role in ensuring compliance with regulatory requirements for biologic products in various markets.Key Responsibilities:Develop and implement regulatory...
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Regulatory Affairs Specialist
6 days ago
Bengaluru, Karnataka, India Baxter Full timeAbout VantiveVantive is a new company built on the legacy of Baxter, a leading healthcare company. We are on a mission to revolutionize kidney care and other vital organ support.Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for supporting all regulatory activities...
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Regulatory Affairs Director
2 days ago
Bengaluru, Karnataka, India Parexel Full timeUnlock Your Potential in Regulatory AffairsAt Parexel, we're seeking a highly skilled Regulatory Affairs professional to join our team. As a Regulatory Affairs Director, you will play a critical role in ensuring the success of our clinical trials by providing expert guidance on regulatory submissions and compliance.10+ years of experience in Clinical Trial...
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Regulatory Affairs Manager
5 days ago
Bengaluru, Karnataka, India Biocon Biologics Full timeJob SummaryWe are seeking a highly experienced Regulatory Affairs Manager to lead our global biosimilar regulatory strategy and ensure compliance with regulatory requirements.The successful candidate will have a strong background in drug substance manufacturing, process characterization, and regulatory strategy development.Develop and execute global...
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National Regulatory Affairs Director
7 days ago
Bengaluru, Karnataka, India Syngene International Limited Full timeJob Title: National Head Regulatory AffairsAt Syngene International Limited, we are seeking a highly skilled and experienced National Head Regulatory Affairs to lead our regulatory affairs function. As a key member of our team, you will be responsible for ensuring compliance with all relevant pharmaceutical regulations in India.Key Responsibilities:Oversee...
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Regulatory Affairs Specialist
7 days ago
Bengaluru, Karnataka, India ResMed Full timeJob SummaryThe Regulatory Affairs function at ResMed plays a critical role in ensuring compliance with regulatory requirements and delivering optimal regulatory strategies for product planning, active regulatory intelligence, and execution excellence. As a key member of the team, you will be responsible for providing support and guidance on regulatory...
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Regulatory Affairs Specialist
2 days ago
Bengaluru, Karnataka, India Biocon Full timeJob Title: Regulatory Affairs SpecialistJob Summary: We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Biocon. The successful candidate will be responsible for preparing, reviewing, and submitting ANDA/ANDS in the US market, including modules.Key Responsibilities:Hands-on experience in preparation, review, and submission of...
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Regulatory Affairs Specialist
7 days ago
Bengaluru, Karnataka, India Parexel Full timeJob Title: Regulatory Affairs AssociateAbout the Role:Parexel is seeking a highly skilled Regulatory Affairs Associate to join our team. As a key member of our regulatory team, you will be responsible for handling the pre and post-approval life cycle management of Biologic products in various markets, including Regulated (EU/US/Canada) and Emerging...
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Regulatory Affairs Specialist
7 days ago
Bengaluru, Karnataka, India Baxter Full timeRegulatory Affairs SpecialistBaxter is a leading healthcare company that is on a journey to separate its ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve.We are seeking a highly skilled Regulatory Affairs...
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Regulatory Affairs Specialist
6 days ago
Bengaluru, Karnataka, India Biocon Full timeJob Title: Formulation Regulatory AffairsAt Biocon, we are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team. This role will be responsible for ensuring compliance with regulatory requirements for our formulation products in the US market.Key Responsibilities:Prepare, review, and submit ANDA/ANDS filings in the US...
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Regulatory Affairs Specialist
3 days ago
Bengaluru, Karnataka, India Baxter Full timeTransforming Healthcare through Regulatory ExcellenceBaxter is a leading global healthcare company that has pioneered significant medical innovations for over 85 years. As a Regulatory Affairs Specialist, you will play a critical role in ensuring the compliance and quality of our products and therapies.Your key responsibilities will include:Creating and...
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Regulatory Affairs Director
6 days ago
Bengaluru, Karnataka, India Parexel Full timeRegulatory Affairs ManagerAt Parexel, we're driven by a shared passion for delivering exceptional results. When our values align, there's no limit to what we can achieve.10+ years of relevant experience in Clinical Trial Regulatory SubmissionsExperience in managing clinical trial studies, playing Regulatory Leads for Global trials, and exposure to the...
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Regulatory Affairs Specialist
5 days ago
Bengaluru, Karnataka, India Philips Full timeJob Title: Principal Regulatory Affairs SpecialistJob Summary:We are seeking a highly experienced Principal Regulatory Affairs Specialist to join our team at Philips. The successful candidate will be responsible for developing and executing the regulatory strategy for new product development, design changes, and field safety corrections for US, EU, and...
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Regulatory Affairs Specialist
2 days ago
Bengaluru, Karnataka, India Philips Full timeJob Title: Principal Regulatory Affairs SpecialistJob Description:The Principal Regulatory Affairs Specialist will play a key role in developing and executing the regulatory strategy for new product development, design changes, and field safety corrections for the US, EU, and RoW. This includes authoring 510k submissions, leading pre-sub meetings, creating...