
Regulatory Affairs Manager
5 days ago
Job Title: Senior Regulatory Manager – RoW Market
Department
: Regulatory Affairs
Job 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 regulatory requirements. The role involves coordination with internal teams, external partners, and regulatory authorities to ensure timely product approvals and lifecycle management.
Key Responsibilities:
- Thorough knowledge of - Dossier Preparation & Review: Prepare and review CTD/eCTD/non-CTD dossiers for new product registrations, renewals, and variations for RoW markets (e.g., Africa, Southeast Asia, CIS, LATAM).
- Ensure dossiers are in line with current regulatory guidelines and client expectations.
- Regulatory Submissions & Approvals: Coordinate with agents for regulatory submission and queries.
- Track and manage timelines for submissions and approvals to ensure compliance with project milestones.
- Regulatory Intelligence & Compliance: Monitor changes in regulatory guidelines and keep relevant stakeholders informed.
- Ensure all submissions and regulatory strategies align with applicable national and international regulations.
- Lifecycle Management: Manage regulatory documentation for product variations, renewals, packaging/labelling updates, and post-approval changes.
- Audit & Documentation: Maintain and update regulatory databases and trackers.
Required Qualifications & Experience:
- Must have experience handling RoW markets.
- Strong knowledge of CTD/non-CTD formats and regulatory requirements of RoW markets.
- Experience in dealing with distributors/agents for regulatory submissions.
Key Skills:
- In-depth understanding of pharmaceutical regulatory processes.
- Strong documentation and technical writing skills.
- Ability to interpret and apply regulatory guidelines effectively.
- Excellent communication, coordination, and project management skills.
- Proficiency in MS Office and regulatory databases.
-
Regulatory Affairs
2 days ago
Ahmedabad, Gujarat, India VITAL INTELLIGENCE TECHNOLOGY PRIVATE LIMITED Full time ₹ 6,00,000 - ₹ 12,00,000 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...
-
Manager- Drug Regulatory Affairs
7 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,...
-
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...
-
Regulatory Affairs Specialist
3 weeks ago
Ahmedabad, Gujarat, India Frisch Medical Devices PVT LTD Full timeJob Title: Regulatory Affairs Junior Manager Location: At Ahmedabad Office , Near Thaltej Crossroads Department: RA Reports To: RA Head and Regulatory Department at HO /Director Employment Type: Full Time Office hours : 9,30 AM to 6 PM Week of: Sunday and Saturday Half Day Preferred Gender : M/F Experience : Minimum 2 years Job Summary: We are...
-
Regulatory Affairs Specialist
3 weeks ago
Ahmedabad, Gujarat, India 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...
-
Regulatory Affairs Manager
2 weeks ago
Ahmedabad, Gujarat, India 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...
-
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...
-
Senior Regulatory Affairs Specialist
5 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...
-
Regulatory Affairs Specialist
2 weeks ago
Ahmedabad, Gujarat, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000Regulatory Document Specialist Role OverviewJob DescriptionPrepare and manage regulatory documents, such as DMF/ASMF/CEP dossiers, in compliance with ICH M4 CTD/eCTD guidelines. This involves reviewing and revising documentation to ensure accuracy and adherence to regulatory requirements.Key ResponsibilitiesPrepare responses to queries from regulatory...
-
Senior Regulatory Affairs Executive
2 days ago
Ahmedabad, Gujarat, India Medipharma Konnect Full time ₹ 15,00,000 - ₹ 25,00,000 per yearWe are hiring a highly experienced Senior Regulatory Affairs Executive for our pharma company in Ahmedabad. The role involves dossier preparation & submission (CTD/ACTD/eCTD), product registration, regulatory strategy, compliance with WHO-GMP/ICH/global guidelines, and handling ROW, LATAM, SEA, Africa, Pacific market approvals.The candidate will also...