Regulatory Affairs Professional
1 week ago
Piramal Group seeks a highly skilled Regulatory Affairs Professional to support the development and commercialization of medical products. This individual will play a key role in ensuring compliance with regulatory requirements and providing scientific input for new product claims.
Responsibilities:- Prepare Red Books for key therapeutic targets
- Provide scientific understanding and training to relevant stakeholders
- Evaluate claims as per regulations and technical requirements
- Conduct research studies to support claims
- Handle consumer and medical queries received through consumer care
The successful candidate will have excellent communication and analytical skills, with the ability to critically review documents for scientific and regulatory compliance. A strong understanding of regulations such as the D&C Act, DMR Act, and UCPMP is essential.
Key Qualifications:
- - years of experience in preparing Red Books and training teams
- Previous regulatory experience in OTC drugs
- Good understanding of operational process of PV Reporting
- Critical review and validation skills
Working Arrangements:
- This role will be based at our office location
- We offer a competitive salary of $120,000 per annum
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Regulatory Affairs Professional
2 weeks ago
Mumbai, Maharashtra, India Chemill Pharma Ltd. Full timeAt Chemill Pharma Ltd., we are seeking an experienced Regulatory Affairs Manager to join our dynamic team. This pivotal role involves ensuring timely regulatory submissions, close coordination with manufacturers, and meticulous document management.Detailed Responsibilities:Review and evaluate assigned dossiers from manufacturers according to country-specific...
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Regulatory Affairs Professional
2 days ago
Mumbai, Maharashtra, India Lifelancer Full timeJob OverviewWe are seeking an experienced Regulatory Affairs Manager to join our team at Lifelancer. This role will be responsible for ensuring the timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
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Regulatory Affairs Professional
2 weeks ago
Mumbai, Maharashtra, India Lifelancer Full timeCompany OverviewLifelancer is a talent-hiring platform connecting professionals with opportunities in Life Sciences, Pharma, and IT.Job SummaryWe are seeking an experienced Regulatory Affairs Trainee to join our team. This role will involve preparation of dossiers for the ROW market under the guidance of a Senior Officer.ResponsibilitiesPreparing and...
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Regulatory Affairs Specialist
2 weeks ago
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Mumbai, Maharashtra, India G&L Healthcare Advisors Full timeKey Job DetailsJob Title: Regulatory Affairs Professional for Medical DevicesLocation: Flexible working arrangements (remote/hybrid)Estimated Salary: £85,000 - £105,000 per annumAbout the RoleWe are seeking a highly experienced Regulatory Affairs professional to join our international team at G&L Healthcare Advisors. As a key member of our team, you will...
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Regulatory Affairs Director
4 days ago
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Regulatory Affairs Professional
3 weeks ago
Mumbai, Maharashtra, India Ashish Life Science Pvt Limited Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Ashish Life Science Pvt. Limited.Key ResponsibilitiesEnsure timely submission of regulatory dossiers, including ANDAs, NDAs, CTDs, and other product approvals.Coordinate with R&D, Quality Assurance, and Manufacturing teams to gather necessary documentation for...
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Regulatory Affairs Specialist
2 days ago
Mumbai, Maharashtra, India Lifelancer Full timeEstablished in Vikhroli West, Lifelancer is a leading talent-hiring platform connecting professionals with opportunities in pharma, biotech, health sciences, and IT domains.We are seeking a highly motivated Regulatory Affairs Trainee to join our team. As a Regulatory Affairs Trainee, you will be responsible for preparing, compiling, and coordinating...
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Regulatory Affairs Associate
4 weeks ago
Mumbai, Maharashtra, India Colgate-Palmolive Company Full timeColgate-Palmolive is seeking a skilled Regulatory Affairs Associate to join our team. In this role, you will be responsible for handling and maintaining product compliance during the entire product life-cycle.Key Responsibilities:Work closely with the Regional Regulatory Affairs Department to ensure compliance with regulatory requirements.Support the...
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Regulatory Affairs Specialist
1 week ago
Mumbai, Maharashtra, India Chemill Pharma Ltd. Full timeChemill Pharma Ltd. is a dynamic organization seeking a seasoned Regulatory Affairs Manager to oversee the regulatory submission process. This role requires strong organizational skills and the ability to manage multiple tasks under tight deadlines.Job Summary:We are seeking an experienced Regulatory Affairs Manager to join our team in ensuring timely...
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Mumbai, Maharashtra, India OMC Medical Limited Full timeCompany OverviewOMC Medical Limited is a healthcare company based in the UK, specializing in UK MHRA Registration, European Authorized Representation, global product registrations, and other regulatory services.Salary £40,000 - £60,000 per annum, depending on experience.Job DescriptionThis is a full-time, remote-based role for a Regulatory Affairs Human...
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Regulatory Affairs Specialist
1 month ago
Mumbai, Maharashtra, India SUN PHARMA Full timeJob Title: Regulatory Affairs SpecialistKey Responsibilities:Ensure compliance with regulatory requirements for API Plant operations.Manage DMF compilation and lifecycle management.Coordinate change control and related submissions.Develop and maintain quality standards.Requirements:Qualifications:Minimum 2 years of experience in regulatory affairs or quality...
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Regulatory Affairs Lead
2 weeks ago
Mumbai, Maharashtra, India Lifelancer Full timeAbout the Role:As a key member of our Regulatory Affairs team, you will provide strategic and operational support to project management on new divestment projects, technical transfer, CMOs, quality assurance, and commercial departments.We are seeking an experienced regulatory affairs professional with expertise in global regulatory intelligence, compliance,...
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Regulatory Affairs Specialist
1 month ago
Mumbai, Maharashtra, India Parexel Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Consultant to join our team at Parexel.As a Regulatory Affairs Consultant, you will be responsible for handling the life cycle management of approved drug products, including tablets, syrups, and parenterals.You will lead and contribute to the planning, preparation, and delivery of regulatory...
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Senior Regulatory Affairs Specialist
1 week ago
Mumbai, Maharashtra, India Vision Achievement Full timeVision AchievementWe are seeking a highly experienced and skilled Senior Regulatory Affairs Specialist to join our team at Vision Achievement. This is an exciting opportunity for professionals who have a passion for patient safety and population health improvement.About the Role:As a Senior Regulatory Affairs Specialist, you will be responsible for planning...
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Regulatory Affairs Strategist
2 weeks ago
Mumbai, Maharashtra, India Abbott Full timeJob Summary">We are seeking an Experienced Regulatory Affairs Manager to join our team at Abbott.About the Role">This is an individual contributor role that works under limited supervision and applies subject matter knowledge in the area of Regulatory Affairs.The ideal candidate will possess well-developed skills in directing development of product...
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Regulatory Affairs Specialist
1 month ago
Mumbai, Maharashtra, India Piramal Group Full timeBusiness: Piramal Pharma Solutions Department: Corporate Regulatory Affairs Job OverviewWe are seeking a skilled Regulatory Affairs Specialist to join our Corporate Regulatory Affairs team at Piramal Pharma Solutions. In this role, you will be responsible for submitting regulatory dossiers for targeted markets as per business needs to support CDMO and Agile...
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Regulatory Affairs Executive Position
2 weeks ago
Mumbai, Maharashtra, India SUN PHARMA Full timeJob Overview:Sun Pharma is seeking a skilled Regulatory Affairs Executive to join our team in Mumbai. This role will be responsible for ensuring compliance with regulatory guidelines and standards.About the Role:The ideal candidate will have minimum 2-4 years of experience in regulatory affairs or quality assurance of API plants or corporate settings. A good...
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Regulatory Affairs Specialist
2 weeks ago
Mumbai, Maharashtra, India Ipca Laboratories Limited Full timeIpca Laboratories Limited is seeking a skilled Regulatory Affairs Executive to join our team. This role will focus on regulatory affairs formulation for the USA market.The ideal candidate will have a strong background in pharmacy and 4-7 years of experience working in regulated markets such as the USA, Europe, and Australia.This position requires:Preparation...
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Regulatory Affairs Director for Medical Devices
2 weeks ago
Mumbai, Maharashtra, India G&L Healthcare Advisors Full timeWe are seeking a highly skilled Regulatory Affairs professional to lead our medical device regulatory strategy and submission processes.Job OverviewG&L Healthcare Advisors is a leading consulting firm in the medical device industry, providing expert guidance and support to clients worldwide.Estimated Salary: $120,000 - $180,000 per yearAbout the RoleThis...