
Regulatory Affairs-Manager
4 days ago
Job Description JOB Responsibility - Preparation, review & submission of ectd/ctd dossier as per requirement of regulated market authorities i.e. Europe, Brazil, Canada, RoW for pharmaceutical products - Preparation, review & submission of dossier as per DCGI requirement for submission in CDSCO - Preparation, review & submission of techpack as per requirement of regulated market authorities i.e. Europe, Brazil, Canada, RoW for Nutraceutical products - Query response raised by (MoH/Customer) to EU, Regulated, and Emerging & ROW of Pharma & Nutra products - Documents review QQF, Change control, specifications, Commercial specifications, artworks - Process Validation Protocols & Report, Hold time study protocol & report, NDMA reports, Photo stability reports, Elemental reports, Risk assessment, Out of Specification. - Co-ordination with external & internal clients. - Updation and maintenance of database of dossier status. - Fulfil requirement for site registration and GMP clearance/approvals
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Regulatory Affairs
3 weeks ago
Nagpur, India Select Source International Full timeRegulatory Affairs Assistant Manager professional: Core Keywords Regulatory Affairs (RA) Assistant Manager Regulatory Affairs Dossier & Submission Expertise CTD / ACTD / eCTD dossier preparation Module 3, Module 5 Lifecycle management (PLCM) Post-approval variations / renewals Regulatory submissions & query responses Client due diligence Ministry of Health...
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Regulatory Affairs
5 days ago
Nagpur, Maharashtra, India Select Source International Full time ₹ 9,00,000 - ₹ 12,00,000 per yearRegulatory Affairs Assistant Manager professional:Core KeywordsRegulatory Affairs (RA)Assistant Manager Regulatory AffairsDossier & Submission ExpertiseCTD / ACTD / eCTD dossier preparationModule 3, Module 5Lifecycle management (PLCM)Post-approval variations / renewalsRegulatory submissions & query responsesClient due diligenceMinistry of Health (MOH)...
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Regulatory Affairs
1 week ago
India Sunrise Remedies Full timeSunrise Remedies Job Opening for Regulatory Affairs (RA). **Experience**: Minimum 2 Years **Industries**: Pharmaceutical Company **Education**: B.Sc. / M.Sc / B.Pharm / M.Pharm **Job Location**: Santej Ahmedabad. **Key Responsibilities**: - Regulatory Affairs Specialists assist in obtaining and maintaining government approval for drugs, medical devices,...
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Regulatory Affairs Specialist
3 weeks ago
india Frisch Medical Devices PVT LTD Full timeJob Title: Regulatory Affairs Junior ManagerLocation: At Ahmedabad Office , Near Thaltej CrossroadsDepartment: RAReports To: RA Head and Regulatory Department at HO /DirectorEmployment Type: Full TimeOffice hours : 9,30 AM to 6 PMWeek of: Sunday and Saturday Half DayPreferred Gender : M/FExperience: Minimum 2 yearsJob Summary:We are seeking a proactive and...
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Regulatory Affairs Manager
2 weeks ago
Delhi, India Wembrace Biopharma Private Limited Full timeJob Description Job Profile The Regulatory Affairs Manager (RAM) for Africa, MENA, and LATAM will lead regulatory strategy, submissions, approvals, and life-cycle management of pharmaceutical, biotech, and nutraceutical products across these diverse regions. The role requires a strong understanding of local health authority requirements, WHO guidance, and...
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Regulatory Affairs Specialist
3 weeks ago
Bengaluru, India Biocon Biologics Full timeJob Description Position Summary The Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings...
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Head- Regulatory Affairs
3 weeks ago
Bengaluru, India Michael Page Full timeJob Description - Drive regulatory strategy with global impact at a leading healthtech innovator - Leadership role with strong visibility and growth potential Job Description 1. Regulatory Strategy Development- Define and drive the regulatory vision and strategy for CRM products, aligning with company's business goals. 2. Leadership and Team Management-...
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Regulatory Affairs Specialist
3 weeks ago
Mumbai, India Tek Support Full timeJob Description Job Title: Regulatory Affairs Specialist Med/Pharma (Female) Location: Remote Position Overview: We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health...
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Regulatory Affairs Associate
2 weeks ago
Surat, India Concept Medical Full timeJob Description About Us: Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are...
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Senior Manager Regulatory Affairs
4 days ago
New Delhi, Delhi, India, Delhi Panacea Biotec Full timePosition: Sr. Manager / AGM – Regulatory AffairsQualification: M.Sc. / Ph.D. (Life Sciences, Biotechnology, or related discipline) Experience: 13–16 years in Regulatory Affairs (vaccines/biologicals)Role:The role is responsible for global product registrations (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and regulatory...