Regulatory Affairs Executive
1 week ago
Role Objective Key objective of this role is to prepare, review, and maintain regulatory documents to ensure compliance with international guidelines and country-specific requirements. The role involves coordination with internal teams and external stakeholders to support product registrations, timely dossier submissions, query responses, and compliance with regulatory standards.Desired Candidate Profile Graduate/Postgraduate in Pharmacy, Life Sciences, Biotechnology, or a related discipline. 3–6 years of relevant experience in regulatory affairs, preferably in pharmaceuticals, biotechnology, or healthcare. Strong understanding of global regulatory guidelines and dossier preparation. Detail-oriented, with excellent organizational and analytical skills. Proficiency in MS Office (Word, Excel, PowerPoint) and document management systems. Good written and verbal communication skills.Roles & Responsibilities Screen and analyze documents received for product registration requests as per country-specific guidelines. Prepare, compile, and review product dossiers in compliance with customer and regulatory requirements. Prioritize dossiers to meet defined timelines and ensure timely submission to the regulatory authorities. Draft and coordinate responses to regulatory queries with appropriate documentation and justifications. Arrange supportive batch-related documents (e.g., DOC, COA) for registration samples. Manage legalization or apostillation of registration documents, including coordination with agencies, tracking timelines, and processing payments/invoices. Support the Compliance team by providing updated documents required for technical file preparation. Periodically review and update Technical Master Files to ensure consistency across product categories. Coordinate with cross-functional teams (Quality, Production, R&D, and Compliance) to fulfill regulatory requirements and address audit queries. Ensure timely preparation and submission of documents related to audit findings. Adhere to departmental priorities and provide support for additional tasks as assigned.Functional Skills Required Knowledge of international regulatory requirements and guidelines. Expertise in dossier compilation, review, and submission processes. Ability to prepare and analyze technical and compliance-related documentation. Familiarity with audit documentation and regulatory query management. Document management and record-keeping skills.Behavioral Skills Required Strong attention to detail and accuracy. Ability to work effectively under pressure and meet strict deadlines. Team player with strong collaboration and coordination skills. Proactive, adaptable, and willing to take initiative. Professional communication and interpersonal skills.Team Size to be Handled: Individual contributor role, reporting to the Assistant Manager - RA.Important Links: Website:https://biotechhealthcare.com/ LinkedIn:https://www.linkedin.com/company/biotechhealthcare/ Instagram:Biotech Vision CareBiotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.
-
Regulatory affairs manager
4 weeks ago
New Delhi, India Self-employed Full timeCompany Description Founded in the commercial operations year of , Next Gen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
-
Regulatory Affairs Manager
4 weeks ago
New Delhi, India Self-employed Full timeCompany DescriptionFounded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
-
Regulatory Affairs Manager
4 weeks ago
New Delhi, India Self-employed Full timeCompany Description Founded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
-
Regulatory Affairs Manager
3 weeks ago
New Delhi, India Self-employed Full timeCompany Description Founded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
-
Regulatory Affairs Manager
2 weeks ago
New Delhi, India Self-employed Full timeCompany Description Founded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
-
Regulatory Affairs Executive
4 weeks ago
Delhi, India Oswal Crop Protection Pvt. Ltd. Full timeCompany Description Oswal Crop Protection Pvt. Ltd. is an ISO 9001:2015 certified company, established by Mr. Ramesh Bansal, who has over 30 years of experience in the pesticides industry. As one of the leading agrochemical companies in India, Oswal Crop Protection is committed to strengthening agriculture with sustainable products and services. Our...
-
Regulatory Affairs Executive
4 weeks ago
Delhi, India Savvi Sales & Services Full timeJob Title: Regulatory Affairs Executive Location: Rohini, Delhi Industry: Pharmaceuticals / Nutraceuticals Salary Package: 25,000 50,000 per month Gender Preference: Male Experience Required: 2–3 years in Pharma or Nutra Industry (Regulatory Affairs) Key Responsibilities: Prepare and submit regulatory dossiers such as INDs, NDAs, ANDAs, MAAs. Ensure proper...
-
Regulatory Affairs Specialist
5 days ago
New Delhi, 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 Time Office hours : 9,30 AM to 6 PM Week of: Sunday andSaturday Half Day Preferred Gender: M/F Experience : Minimum 2 yearsJob Summary: We are seeking a proactive...
-
Senior Manager Regulatory Affairs
3 days ago
New Delhi, India Panacea Biotec Full timePosition: Sr. Manager / AGM – Regulatory Affairs Qualification: 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...
-
Senior manager regulatory affairs
1 week ago
New Delhi, India Panacea Biotec Full timePosition: Sr. Manager / AGM – Regulatory Affairs Qualification: 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 (Lat Am, Africa, GCC etc.), WHO Prequalification, Product lifecycle...
