Regulatory Affairs Lead
3 days ago
Role & responsibilities
Need sound knowledge of domestic regulatory functions with ref to DBT-RCGM, CDSCO and state FDA regulations.
Will prepare and submit dossier to RCGM for approval of PCT application to dept of
Biotechnology
Review and timebound submission of application for MAA, PAC, CT (Phase I, II and Phase III
applications),
Responsible for IBSC meeting conduction and related regulatory activities.
Preferred candidate profile
Perks and benefits
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Regulatory Affairs
5 days ago
Ahmedabad, Gujarat, India Medipharma Konnect Full time ₹ 12,00,000 - ₹ 36,00,000 per yearWe are hiring Regulatory Affairs (RA) Executive / Manager for a leading Pharma company in Ahmedabad. The candidate will be responsible for dossier preparation, product registration, regulatory submissions, and maintaining compliance with international guidelines (ROW / LATAM / Africa). Must have hands-on experience in RA documentation for pharma...
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Regulatory Affairs Officer
1 week ago
Ahmedabad, Gujarat, India CLAPS Industries Private Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per yearCompany DescriptionCLAPS Industries Pvt Ltd. is a global pharmaceutical company founded by a team of visionary and successful individuals in the pharmaceuticals field. With a focus on delivering top-quality healthcare products and services worldwide, CLAPS is rapidly growing through product diversification, strategic manufacturing expansions, and strong...
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Regulatory Affairs Executive
6 days ago
Ahmedabad, Gujarat, India nutralike formulation Pvt Ltd Full time ₹ 4,00,000 - ₹ 8,00,000 per yearNutralike is a leading nutraceutical manufacturer offering premium-quality products across tablets, capsules, powders, and syrups. With global compliance standards and presence across ROW, Middle East, EU, CIS, and GCC markets, Nutralike focuses on innovation, safety, and quality. Learn more at Job Summary:The Regulatory Affairs Executive will be...
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International regulatory Affairs
5 days ago
Ahmedabad, Gujarat, India CLAPS Industries Private Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per yearCompany DescriptionCLAPS Industries Pvt Ltd. is a global pharmaceutical company that was founded by a visionary team of highly successful individuals in the field of pharmaceuticals. The company is dedicated to providing high-quality healthcare products and services globally. CLAPS is expanding rapidly through product diversification, strategic...
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Manager- Drug Regulatory Affairs
4 days ago
Ahmedabad, Gujarat, India Lezivia Lifesciences Full time ₹ 15,00,000 - ₹ 25,00,000 per yearCompany DescriptionLezivia Lifesciences is a reputed company known for its quality pharmaceutical products. Most of our products are manufactured at WHO-approved facilities, ensuring the highest quality standards for patient care. We are dedicated to delivering the best products to improve patient outcomes and well-being.Role DescriptionThis is a full-time,...
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Deputy Regulatory Affairs Manager
5 days ago
Ahmedabad, Gujarat, India Opes Healthcare Full time ₹ 4,00,000 - ₹ 12,00,000 per yearRole & responsibilitiesTo lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats.Responsible for final review of dossier before submission.Reviewing artwork for products as per relevant regulatory authority requirements.Coordination with F&D, QA, QC & Store for documentationIn-depth knowledge of pharmaceutical documentation &...
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Senior Regulatory Affairs Specialist
2 days ago
Ahmedabad, Gujarat, India Jain Soap & Jain Lifecare Pvt Ltd Full time ₹ 32,00,000 - ₹ 48,00,000 per yearJob Title:Sr. Regulatory ExecutiveLocation:Vadsar, GandhinagarCTC:₹4.0 LPA – ₹6 LPAExperience Required:2–4 years in Regulatory Affairs (Pharma or Cosmetics)Educational Qualification:B.Pharm / M.Pharm – Drug Regulatory Affairs, Quality Assurance, Pharmacology, or Pharmaceutical AnalysisRoles & Responsibilities:Prepare and review dossiers in...
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Officer - Plant Regulatory Affair Department
5 days ago
Ahmedabad, Gujarat, India Emcure Full time ₹ 9,00,000 - ₹ 12,00,000 per yearRoles and ResponsibilitiesPrepare dossiers for US FDA, including CTD format.Ensure regulatory compliance with RA requirements.Manage parenteral products' dossier preparation and submission to regulatory authorities.Coordinate with cross-functional teams for injectable product development and registration.Track regulatory updates and maintain records in...
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Regulatory Affairs Manager
2 days ago
Ahmedabad, Gujarat, India Red Envelope Consultants Full time ₹ 15,00,000 - ₹ 25,00,000 per yearJob Title: Senior Regulatory Manager – RoW MarketDepartment: Regulatory AffairsJob Summary:The Senior Regulatory Manager will be responsible for the preparation, review, and submission of high-quality regulatory dossiers and documents for pharmaceutical products intended forRest of the World (RoW) markets, ensuring compliance with country-specific...
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Senior Regulatory Affairs Executive
2 weeks ago
Ahmedabad, Gujarat, India Synerxia Healthcare Full time ₹ 5,00,000 - ₹ 12,00,000 per yearJob descriptionSYNERXIA Healthcare Pvt Ltd is engaged into Manufacturing & Exports of Nutraceuticals-Health/Dietary Supplements along with Pharmaceutical Products, is one of the Upstart organization is looking for position in Regulatory Affairs - Emerging / ROW Market for pre-submission and post-submission.Role and responsibilities Responsible for...