Regulatory Affairs Manager

24 hours ago

Pune, 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 AffairsExperience:8–12+ years of Regulatory Affairs experience in Nutraceuticals, Dietary Supplements, Herbal Extracts, Functional Foods, or Pharma (with strong exposure to nutraceutical regulations).Strong background in compiling and reviewing Technical Dossiers:Ingredient dossiersRegulatory compliance documentsSafety and toxicology dataStability dataLabel claim substantiationSalary: As per the Market StandardsLocation: Shri Kartikeya Pharma, 3rd Floor, PBN Centre, Road No:45, Jubilee Hills, Hyderabad-500033Purpose of the Role:The Global Regulatory Affairs Manager will oversee all regulatory compliance activities related to the company’s nutraceutical products, ensuring that all the marketing practices meet applicable global standards (e.g., FDA (U.S.), EFSA (EU), FSSAI (India).Key Deliverables:Regulatory Strategy& Compliance.Develop and implement regulatory strategies for product launches and market expansions.Ensure the certifications are renewed on time and also apply for new certifications in new geographies.Interpret and apply country-specific regulations (FDA/DSHEA, EFSA, FSSAI, etc.) to ensure compliance.Dossier & Documentation Management.Prepare and maintain regulatory submissions, including product dossiers, GRAS documentation, and ingredient justifications.Ensure technical files and records (safety data, clinical support for claims, specifications) are audit-ready.Labelling, Claims & Marketing Review.Review and approve labels, packaging, and marketing materials for regulatory compliance.Evaluate substantiation for health and structure/function claims to ensure legal acceptability.Cross-functional CollaborationCollaborate with R&D, Quality ,Marketing, and Legal teams to align product development with regulatory requirements.Provide regulatory support during product lifecycle management and reformulations.Regulatory LiaisonAct as the point of contact with national and international regulatory agencies (e.g., FDA, EFSA, FSSAI, TGA).Lead the response to agency inquiries, inspections, or compliance reviewsTraining & Risk ManagementProvide internal training on new regulations and compliance procedures.Identify and mitigate regulatory risks associated with ingredients, claims, or labelling.Required Qualifications:Bachelor's or Master’s degree in Pharmacy, Food Science, Chemistry, Life Sciences, or a related discipline.5+ years of experience in regulatory affairs in the nutraceutical, dietary supplement, or functional foods sector.Strong knowledge of international regulatory frameworks: FDA/DSHEA (U.S.), EFSA (EU), FSSAI (India).Familiarity with Codex Alimentarius and GMP guidelines preferred.Excellent written and verbal communication skills.Attention to detail and experience handling complex documentation.

  • Regulatory Affairs Manager

    1 week ago

    Pune, India Whatjobs IN C2 Full time

    Dear Candidate, We are hiring for the Regulatory Affairs role-handling the below job responsibilities, Job Title: Regulatory Affairs Manager Company: Brinton Pharmaceuticals Ltd. Location: Kharadi, Pune Salary: Best in Industry Joining: Immediately Job Description: Regulatory Affairs Manager Position Overview: We are seeking an experienced and resourceful...

  • Regulatory Affairs Manager

    2 weeks ago

    Pune, Maharashtra, India Batavia Pharma Pvt Ltd Full time

    Role & responsibilitiesRole Overview:The Regulatory Affairs Manager will be responsible for overseeing all regulatory aspects of projects, ensuring compliance with global guidelines, and leading regulatory submission. Responsible for preparing, reviewing, and compiling high-quality CMC (Chemistry, Manufacturing, and Controls) documentation for regulatory...

  • Regulatory Affairs Specialist

    7 days ago

    Pune, Maharashtra, India Philips Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Job TitleRegulatory Affairs SpecialistJob DescriptionJob title:Regulatory Affairs SpecialistYour role:Be recognized as a key talent in International Regulatory filings and procedures.Be considered a key regulatory point person in Centralization of Regulatory Operations and enable the regulatory compliance in Markets where Philips products are...

  • Manager Regulatory Affairs

    6 days ago

    Pune, Maharashtra, India Emcure Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Role: Regulatory Affairs ManagerJob Location: PuneExp: 8-14 YearsQualification: B.Pharm/M.PharmJob Responsibilities:Dossier preparation, Submission, Compilation, Query Response, Variation fillingResponsible for pre and post approval activities.Handling Europe Market.Strong knowledge of EU regulatory frameworks and guidelines (e.g., EMA, ICH, eCTD).Experience...

  • Regulatory Affairs Analyst

    1 week ago

    Pune, Maharashtra, India Varex Imaging Corporation Full time ₹ 4,00,000 - ₹ 12,00,000 per year

    To apply to a Varex Imaging position, please create an account and sign-in.CURRENT VAREX IMAGING EMPLOYEES: Please apply by logging into your internal Workday Account.SummaryVarex Imaging Regulatory Affairs Analyst participates in the compliance of medical and industrial x-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional...

  • Regulatory affairs analyst

    3 days ago

    Pune, 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 Analyst

    2 days ago

    Pune, 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 Analyst

    3 days ago

    Pune, 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 Analyst

    3 days ago

    Pune, 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 Analyst

    3 days ago

    Pune, 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...