Officer/Executive - Regulatory Affairs

2 weeks ago


Mumbai, Maharashtra, India NMS Consultant Full time ₹ 1,50,000 - ₹ 28,00,000 per year

Role & responsibilities

  • Responsible for activities related to US/EU market.
  • Prepare the registration dossiers as per regulatory guidelines.
  • Submitting GCC dossiers, variations, and query responses through eCTD software.
  • Ensure timely preparation of the agency's query responses to expedite approvals.
  • Prepare and submit post-registration variations application,  Involved in the renewal process of drug registration.
  • Review technical documents on receipt from various departments before inclusion in various applications  and dossiers.
  • Maintenance of the regulatory database for the US market.
  • Product Lifecycle Management .
  • Discuss and coordinate with cross-functional teams like QA, QC, R&D, Analytical, marketing,
  • manufacturing plant, administrative dept., etc. for finalization of documents and with API vendor for getting  DMF, LOA, CEP, and other API-related documents .
  • Responsible for getting the FDA-approved documents legalized such as Notary, Chamber, Apostille,  Embassy, etc.
  • Responsible for sending the hard copies of documents, samples, columns, impurities, placebo, etc. to respective countries of evaluation
  • Being updated with relevant regulatory guidelines.

  • Regulatory Affairs

    3 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...

  • Regulatory Affairs

    2 weeks ago


    Navi Mumbai, Maharashtra, India Peoplefy Full time

    &## ; We're Hiring: Regulatory Affairs – CMC Associate &## ; Location: Navi Mumbai &## ; Years of Experience:4+ years &## ; Work from Office &## ; Notice Period: Looking for immediate joiners Skills Required: &## ; Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field. &## ; 4+ years of experience in Regulatory Affairs...


  • Mumbai, Maharashtra, India Chemical Manufacturing Full time

    Job Title: Senior Executive / Assistant Manager – Regulatory Affairs Location: Mumbai, India (On-site) Employment Type: Full-time | Permanent Experience Required: 3 to 8 years Industry: Chemicals | Pharmaceuticals | Food & Beverages Job Function: Legal | Quality Assurance | Regulatory Affairs Salary: up to 9 LPA About the Role: We are hiring for...


  • Navi Mumbai, Maharashtra, India METSL Full time ₹ 3,00,000 - ₹ 4,00,000 per year

    Dear Candidates,We have job opportunity for the position of Regulatory Affairs Executive & QMR in our leading manufacturing Medical Devices companies.Position:-Regulatory Affairs Executive & Quality Management RepresentativeExperience:-2 to 4 yrsGender:-Male/FemaleThe JD as follows:-· Maintain regulatory files. Maintain and update regulatory authorizations,...


  • Navi Mumbai, Maharashtra, India Peoplefy Infosolutions Full time ₹ 15,00,000 - ₹ 28,00,000 per year

    We're Hiring: Regulatory Affairs CMC Associate Location: Navi Mumbai Years of Experience:4+ years Work from Office Notice Period: Looking for immediate joiners Skills Required: Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field. 4+ years of experience in Regulatory Affairs (CMC), preferably in a pharmaceutical or...


  • Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 4,00,000 - ₹ 9,00,000

    Regulatory Affairs SpecialistOur ideal candidate will manage regulatory registrations, oversee certification renewal documents, and conduct internal audits.Job Description:Lead the management of REACH registrations across EU, Korea, Turkey, and UK, including tonnage upgrades and compliance letters.Handle customer inquiries and provide necessary declarations...


  • Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000

    Job Title: Regulatory Affairs Specialist Objective:The ideal candidate will prepare, review, and maintain regulatory documents to ensure compliance with international guidelines and country-specific requirements.Key Responsibilities:Screen and analyze documents received for product registration requests as per country-specific guidelines.Prepare, compile,...


  • Navi Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 6,00,000 - ₹ 8,00,000

    Regulatory Affairs SpecialistOur organization is seeking an experienced Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong understanding of US FDA regulations and ICH guidelines.Key Responsibilities:• Develop and implement regulatory strategies for new and existing products• Collaborate with cross-functional teams to...


  • Mumbai, Maharashtra, India NOVO Medi Sciences Pvt ltd Full time ₹ 7,00,000 - ₹ 9,00,000 per year

    Required Regulatory Affairs | Chembur Salary: Job Title: Regulatory Affairs Location: Chembur Key Responsibilities: Regulatory Expertise: Manage the regulatory process for Pharmaceutical Finished Formulations across CIS, LATAM, and Africa. Dossier Management: Compile and review ACTD and CTD dossiers to ensure accuracy and compliance. MOH Query Response:...


  • Mumbai, Maharashtra, India Ztek Consulting Full time

    Job Description – Regulatory Affairs CMC Associate (US Market) We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities. Key Responsibilities: Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format....