Senior Regulatory Affairs Officer
2 weeks ago
Dossier Preparation & Compilation:
Lead the preparation, review, and submission of regulatory dossiers in CTD, ACTD, and eCTD formats for global markets, ensuring adherence to country-specific regulations.
Regulatory Strategy & Market Compliance:
Develop and implement regulatory strategies for product approvals across ROW, LATAM, SEA, Africa, and Pacific regions.
Bioequivalence Studies & Compliance:
Coordinate with CROs to ensure compliance and timely approval of bioequivalence studies for international submissions.
Product Lifecycle Management:
Oversee regulatory activities throughout the product lifecycle including renewals, variations, and post-marketing compliance.
Product Registration & Market Expansion:
Handle product registration processes, liaise with authorities, and ensure smooth approvals in targeted regions.
Technical File Review:
Review technical documentation to ensure accuracy and completeness for regulatory filings.
Regulatory Compliance & Audits:
Ensure compliance with country-specific guidelines including WHO-GMP, ICH, and other global standards.
Regulatory Documentation & Reporting:
Maintain accurate and updated regulatory records and provide timely reports to senior leadership.
Stakeholder Management:
Act as the key liaison between regulatory bodies, internal departments, and external partners.
Process Improvement & Team Leadership:
Mentor junior team memb
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Regulatory Affairs Officer
2 weeks 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
2 days ago
Ahmedabad, Gujarat, India VITAL INTELLIGENCE TECHNOLOGY PRIVATE LIMITED Full time ₹ 2,50,000 - ₹ 7,50,000 per year**Vivanza Biosciences Limited** is seeking a highly motivated and detail-oriented professional to join our team as a **Regulatory Affairs Executive** in Ahmedabad, Gujarat. This role is ideal for an individual with foundational experience in the pharmaceutical industry who is keen to grow their career in regulatory compliance and submissions for global...
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regulatory affairs
2 hours ago
Ahmedabad, Gujarat, India Sunrise Remedies Full time ₹ 15,00,000 - ₹ 28,00,000 per yearSunrise Remedies Job Opening for Regulatory Affairs (RA) officer.Experience: 1 YearIndustries: Pharmaceutical CompanyEducation: B.Sc. | M.Sc | B.Pharm | M.PharmJob Location: Santej Ahmedabad.Facilities Provided:– Transportation Facility Available (As Per Circumference Of Sunrise Remedies)*– Mediclaim and Food Facility provide By Company.*Key...
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Regulatory Affairs Manager
6 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 Specialist
6 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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Regulatory Affairs Executive
2 days ago
Ahmedabad, Gujarat, India Vital Group Full time ₹ 12,000 - ₹ 14,90,645 per yearJob Opening: Regulatory Affairs Executive | Vital GroupLocation: SG Highway, AhmedabadExperience: 1–3 years (Pharma Industry)Key Responsibilities:Preparation and submission of dossiers, CTD/ACTD, and regulatory documents.Handling regulatory queries and compliance requirements.Coordination with internal teams to ensure timely submissions.Support in product...
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International regulatory Affairs
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 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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Regulatory Affairs Specialist
2 weeks ago
Ahmedabad, Gujarat, India, Gujarat Frisch Medical Devices PVT LTD Full timeJob Title: Regulatory Affairs Junior ManagerLocation: At Ahmedabad Office , Near Thaltej Crossroads Department: RA Reports To: RA Head and Regulatory Department at HO /Director Employment Type: Full TimeOffice hours : 9,30 AM to 6 PMWeek of: Sunday and Saturday Half Day Preferred Gender : M/FExperience: Minimum 2 years Job Summary:We are seeking a...
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Sr Regulatory Affairs Officer/ Executive
2 days ago
Ahmedabad, Gujarat, India Winston Hr Services Full time ₹ 9,00,000 - ₹ 12,00,000 per yearJob Title:Sr. International Regulatory Affairs Executive/OfficerCompanies: PharmaLocation: Ahmedabad BodakdevExp: 4-6 Yrsemail: Whatsapp: Openings: 02 Required Candidate profilePreparing & review Dossiers for registration of products in various ROW marketsLegalization of FDCA documents for respective country registrationPreparing, managing FSC & COPP...
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Regulatory Affairs Manager
2 weeks ago
Ahmedabad, Gujarat, India, Gujarat Red Envelope Consultants Full timeJob 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 for Rest of the World (RoW) markets, ensuring compliance with country-specific...