Executive / Senior Executive - Regulatory Affairs (Domestic)

1 day ago


Mumbai, India Pharma Placements Full time
  • 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



  • Mumbai, Maharashtra, India CareerFit Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Designation: 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...


  • Mumbai, India CareerFit Full time

    Designation: 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 year

    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...

  • Regulatory Affairs

    2 weeks ago


    Mumbai, Maharashtra, India CliniLaunch Research Institute Full time

    Job 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...


  • Mumbai, Maharashtra, India Illusion Dental Laboratory Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Job 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 year

    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 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 year

    Position: 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 time

    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...

  • Regulatory Affairs

    1 day ago


    Mumbai, India Win in Life Academy Full time

    Position: 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....


  • Mumbai, Maharashtra, India Ipca Laboratories Limited Full time ₹ 15,00,000 - ₹ 20,00,000 per year

    Position : 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...