Regulatory Affairs Specialist(CDSCO, SUGAM,DGCI-Domestic Only)-Mumbai

3 days ago

Mumbai India CliniLaunch Research Institute Full time

Job Description Position: 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 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. 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.

  • Regulatory Affairs Associate

    3 weeks ago

    Surat, India Concept Medical Full time

    Job Description About Us: Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are...

  • Medical Affairs Manager

    6 days ago

    Mumbai, India Ipca Laboratories Limited Full time

    Designation : Asst Manager/Manager – Medicoregulatory Affairs Department : Medicoregulatory Affairs Job location : Kandivali-West, Mumbai Responsibilities I To independently review following applications online through Sugam Portal to CDSCO: Import license of reference product for BE studies BE study NOC for export purpose Manufacture of new drugs to be...

  • Regulatory Affairs Associate

    2 weeks ago

    Surat, Gujarat, India, Gujarat Concept Medical Full time

    About Us:Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the...

  • Medical Affairs Manager

    4 weeks ago

    Mumbai, India Ipca Laboratories Limited Full time

    Designation : Asst Manager/Manager – Medicoregulatory Affairs Department : Medicoregulatory Affairs Job location : Kandivali-West, Mumbai Responsibilities I To independently review following applications online through Sugam Portal to CDSCO: - Import license of reference product for BE studies - BE study NOC for export purpose - Manufacture of new...

  • Medical Affairs Manager

    4 weeks ago

    Mumbai, India Ipca Laboratories Limited Full time

    Designation : Asst Manager/Manager – Medicoregulatory AffairsDepartment : Medicoregulatory AffairsJob location : Kandivali-West, MumbaiResponsibilitiesI To independently review following applications online through Sugam Portal to CDSCO:Import license of reference product for BE studiesBE study NOC for export purposeManufacture of new drugs to be...

  • [23/09/2025] Medical Affairs Manager

    4 weeks ago

    Mumbai, India Ipca Laboratories Limited Full time

    Designation : Asst Manager/Manager – Medicoregulatory Affairs Department : Medicoregulatory Affairs Job location : Kandivali-West, Mumbai Responsibilities I To independently review following applications online through Sugam Portal to CDSCO: 1. Import license of reference product for BE studies 2. BE study NOC for export purpose 3. Manufacture of new...

  • Regulatory Affairs Specialist

    7 days ago

    Mumbai, India OrbiTouch HR (orbiTouch outsourcing pvt ltd) Full time

    Job Description Designation : Regulatory Affairs Specialist Qualifications: Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry Experience : Minimum 4 years of experience in regulatory affairs Salary : good hike on current salary Location : Sandhurst Road Mumbai - Head office Essential Duties and Responsibilities: -...

  • Medical Affairs Manager

    2 weeks ago

    Mumbai, Maharashtra, India, Maharashtra Ipca Laboratories Limited Full time

    Designation : Asst Manager/Manager – Medicoregulatory Affairs Department : Medicoregulatory AffairsJob location : Kandivali-West, MumbaiResponsibilities I To independently review following applications online through Sugam Portal to CDSCO:Import license of reference product for BE studiesBE study NOC for export purpose Manufacture of new drugs to be...

  • Regulatory Affairs Specialist

    2 weeks ago

    Ahmedabad, Gujarat, India, Gujarat Frisch Medical Devices PVT LTD Full time

    Job 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...

  • Head- Regulatory Affairs

    4 weeks ago

    Bengaluru, India Michael Page Full time

    Job Description - Drive regulatory strategy with global impact at a leading healthtech innovator - Leadership role with strong visibility and growth potential Job Description 1. Regulatory Strategy Development- Define and drive the regulatory vision and strategy for CRM products, aligning with company's business goals. 2. Leadership and Team Management-...