
Executive / Senior Executive - Regulatory Affairs (Domestic)
1 day ago
- JOB DESCRIPTION Regulatory Affairs (Domestic)
The role will involve expertise in D & C Act and Rules as well as FSSAI regulations with experience in FDA related activities. This profile will ensure timely and robust functional/cross functional coordination (R&D, QC, Marketing, Legal, Production, etc.), transparent execution and implementation of regulatory affairs and safety processes.
- Local Regulatory Function (Licensing):
- Prepare registration dossier for procuring certificates/license from local FDA, DCGI and FSSAI. This would entail thorough familiarity with FDA, Sugam & FSSAI online portal, Drugs & Cosmetics Act and its various Schedules e.g. Sch Y, M, etc.
- Confirm product formula and label acceptability, as well as the receipt of necessary licenses, prior to the release of product.
- Co-ordinate with QC and R&D departments for technical documents (manufacturing documents like batch records, specifications, analytical methods, validation reports, and stability data) required to be incorporated in the registration dossiers.
- Ensure timely renewal of drug and food licenses maintained by head office and also branch offices based at various states in the country.
- Online application for obtaining test license for import purpose.
- Maintain archival of all regulatory permissions. o Keep abreast of the updates pertaining to regulatory requirements and accordingly implement them.
- Prepare responses to the legal & technical queries raised by the Regulatory authorities. Compliance of Packaging Modules:
- Formulate and implement statutory requirements pertaining to the artworks of the products (label, carton, package insert, patient information leaflet, etc.).
- Review the artwork of all packaging material.
- Prepare package insert as per New Drugs and Clinical Trials Rules 2019.
- Pharmacovigilance :
- Provide high quality medical writing from planning and coordination of literature research.
- Draft and review PSURs with focus on medical aspects of the products and safety sections.
- Review of Risk Management Plans as per Regulatory requirement.
- Good knowledge in assessing the risk-benefit of a product and identify any gaps in the aggregate documents.
- Perform scientific review of aggregate reports / ICSRs produced by PV Associates.
- Educational Qualification: B. Pharma / M. Pharma / Pharm D.
- Experience: 1 - 4 years of similar role in a leading Pharma Company.
Those of you whose profile matches the above mentioned description and would like to apply for this job shall forward their updated resume to
-
Senior Regulatory Affairs Executive
5 days ago
Mumbai, Maharashtra, India CareerFit Full time ₹ 15,00,000 - ₹ 25,00,000 per yearDesignation: Senior Executive Regulatory Affairs & QAJob Profile:Responsible for registration of Pharmaceutical, Nutraceutical, Cosmetic products especially in international markets like ROW, MENA, SEA, LATAM etc.Compile, Review & Submit the Dossiers to the Distributors as per the MOH guidelines.Coordinating & follow-up up with the suppliers and distributors...
-
Senior Regulatory Affairs Executive
1 day ago
Mumbai, India CareerFit Full timeDesignation: Senior Executive Regulatory Affairs & QA Job Profile: Responsible for registration of Pharmaceutical, Nutraceutical, Cosmetic products especially in international markets like ROW, MENA, SEA, LATAM etc. Compile, Review & Submit the Dossiers to the Distributors as per the MOH guidelines. Coordinating & follow-up up with the suppliers and...
-
Mumbai, Maharashtra, India Pharma Placements Full time ₹ 8,00,000 - ₹ 12,00,000 per yearJOB DESCRIPTION Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations with experience in FDA related activities. This profile will ensure timely and robust functional/cross functional coordination (R&D, QC, Marketing, Legal, Production, etc.), transparent execution and implementation of regulatory...
-
Regulatory Affairs
2 weeks ago
Mumbai, Maharashtra, India CliniLaunch Research Institute Full timeJob DescriptionPosition: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).JOB DESCRIPTION Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This profile...
-
Regulatory Affairs Executive
2 weeks ago
Mumbai, Maharashtra, India Illusion Dental Laboratory Full time ₹ 9,00,000 - ₹ 12,00,000 per yearJob Title: Regulatory AffairsNo of Vacancy: 1Job Location: Andheri WestYears of Experience: 1-4 yearsWorking Days: Monday to SaturdayJob Summary:We are seeking a motivated and detail-orientedRegulatory Affairs Executiveto join our team. The ideal candidate will be responsible for preparing and maintaining regulatory documentation to ensure compliance with...
-
Regulatory Affairs
2 weeks ago
Mumbai, Maharashtra, India CliniLaunch Research Institute Full time ₹ 9,00,000 - ₹ 12,00,000 per yearPosition: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).JOB DESCRIPTION – Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This profile will ensure...
-
Regulatory Affairs
2 weeks ago
Mumbai, Maharashtra, India Win in Life Academy Full time ₹ 6,00,000 - ₹ 12,00,000 per yearPosition: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).Experience- 1-5 YearsJOB DESCRIPTION – Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This...
-
Regulatory Affairs
1 day ago
Mumbai, India CliniLaunch Research Institute Full timePosition: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic). Location: Andheri, Mumbai. Qualification: M. Pharm. (Experienced preferred). JOB DESCRIPTION – Regulatory Affairs (Domestic) The role will involve expertise in D & C Act and Rules as well as FSSAI regulations with experience in FDA related activities. This profile will...
-
Regulatory Affairs
1 day ago
Mumbai, India Win in Life Academy Full timePosition: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic). Location: Andheri, Mumbai. Qualification: M. Pharm. (Experienced preferred). Experience- 1-5 Years JOB DESCRIPTION – Regulatory Affairs (Domestic) The role will involve expertise in D & C Act and Rules as well as FSSAI regulations with experience in FDA related activities....
-
Regulatory Affairs Executive
2 weeks ago
Mumbai, Maharashtra, India Ipca Laboratories Limited Full time ₹ 15,00,000 - ₹ 20,00,000 per yearPosition : Executive - Regulatory affairs formulation for USA market. Qualification : B.Pharm/M.Pharm Experience : 4 - 7 years experience of working in regulated markets like USA/ Europe/Australia with experience of ANDA, USA market preferred. Role:Preparation of registration dossiers as per the US Regulatory guidelines Preparation of renewal application as...