API Regulatory Affairs

4 weeks ago

New Delhi, India Biocon Ltd Full time

Role -API Regulatory Affairs - DMF Filing/ Compilation (Global market) Level - Assistant Manager/Deputy Manager /Associate Manager Level:-Required Education/Exp :-Experience Req.: 7 yrs. - 15 yrs. Qualification: - M.Sc. / M.Pharma Responsibilities 1. Hands on Regulatory Affairs-API /DMF Filing/ DMF Compilation/ Submission/ Customer Communication etc. 2. Compilation and submission of DMFs globally for small molecule APIs in eCTD format and in-line with ICH and region specific (EU, US, Canada, Japan, Australia, Brazil, China, South Korea etc.) regulatory guidelines. 3. Should have good knowledge of all the regulatory guidelines and API Regulatory processes. 4. Compilation of response to queries received from Regulatory Agencies & customers globally and submission of response within the stipulated timeline. 5. Review and submission of new DMFs, deficiency responses, amendments, updations to various regulatory agencies. 6. Evaluation of change controls and updating to agencies by considering change categories. 7. Should have hands-on experience in eCTD softwareCandidates with relevant exp.,kindly share CVs to apply on : - rashmi.gupta@biocon.comKindly mention below details whilesharing CV :-Total Exp? Current CTC? Total number of DMF filings? Handling which major markets globally ? Notice Period? Ready to work in Bangalore (onsite) ? (5 Days working)

  • GM – Quality

    5 days ago

    New Delhi, India LOXIM Industries Limited Full time

    Title:GM – Quality & Regulatory Affairs (Pharmaceutical API & Intermediate) Location:Ahmedabad, Gujarat Experience:> 15 years in API Quality & Regulatory roles, including leadership positions Education:M. Pharm / M.Sc. (Chemistry or Pharmaceutical Sciences); Ph.D preferredAbout LOXIMSince its inception in 1977,LOXIM INDUSTRIES LIMITEDhas grown to become...

  • Regulatory Affairs Manager

    1 day ago

    New Delhi, India Ixoreal Biomed Full time

    About the Company : Shri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts.Title: Manager/Senior Manager- Global Regulatory Affairs Experience: 8–12+ yearsof Regulatory Affairs experience in Nutraceuticals, Dietary Supplements,...

  • Regulatory Affairs Associate

    2 weeks ago

    New Delhi, India HCLTech Full time

    Experience: 2 to 5 yearsEducation: Bachelor's degree in Biomedical, Mechanical, or B.PharmWe are looking for talented professionals for roles in Quality Assurance, Regulatory Affairs, and Documentation in the Medical Devices domain.Skills & Requirements:Minimum 3 years of experience in Medical Devices Regulatory Affairs, Quality Assurance, or Documentation-...

  • Regulatory Affairs Associate

    3 weeks ago

    New Delhi, India HCLTech Full time

    Experience:2 to 5 years Education:Bachelor's degree in Biomedical, Mechanical, or B.PharmWe are looking for talented professionals for roles inQuality Assurance ,Regulatory Affairs , andDocumentationin theMedical Devicesdomain.Skills & Requirements: Minimum 3 years of experience in Medical DevicesRegulatory Affairs ,Quality Assurance , orDocumentation Strong...

  • Executive - Regulatory Affairs

    10 hours ago

    Delhi, Delhi, India Domnic Lewis Pvt. Ltd Full time

    **Executive - Regulatory Affairs - Delhi**: **Domnic Lewis has been mandated to hire for Executive - Regulatory Affairs - Delhi** **Position Title**: Executive - Regulatory Affairs **Grade**: C **Reports to**: Lead/Manager - Regulatory Affairs **Position Purpose**: - Monitor and report the status of all product licenses in a timely and accurate manner -...

  • Regulatory Affairs Analyst

    3 days ago

    New Delhi, India Varex Imaging Corporation Full time

    Varex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the...

  • Regulatory Affairs Specialist

    1 week ago

    New Delhi, India Gentell Full time

    Gentell is one of the largest vertically integrated wound care companies in the world. Based in Yardley, PA and with offices, distribution centers and manufacturing plants around the world, our purpose is to make a positive difference in the quality of life for the injured, the chronically ill and those near the end of life.Our success is a result of the...

  • Regulatory Affairs Executive

    6 days ago

    Delhi, Delhi, India SAVVI SALES AND SERVICE PVT.LTD. Full time

    Job 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,...

  • Drug Regulatory Affairs

    1 week ago

    New Delhi, India Curiza Life Sciences Full time

    **Job Role: International Regulatory Affairs** Responsible for compilation & submission of Dossier of a generic drug. Hand on experience in Filing dossiers to regulated, emerging and ROW markets. Experienced in CTD/ACTD and Regional Module. Experience in Filing in EU, ASEAN, MIDDLE EAST AND LATAM regions. To obtain approvals for relevant product...

  • Regulatory Affairs Manager

    2 weeks ago

    New Delhi, India Chemill Pharma Ltd. Full time

    Purpose of the Role:Chemill Pharma is seeking a seasoned and detail-oriented Regulatory Affairs Manager to lead and oversee all regulatory activities across ASEAN markets and Hong Kong, while providing regional support for other territories as needed. The ideal candidate will have strong experience in managing end-to-end product registrations, leading teams,...