HomeRegulatory AffairsManager Regulatory Affairs (Nutraceuticals) | Tirupati Medicare Ltd | Paonta Sahib

Manager Regulatory Affairs (Nutraceuticals) | Tirupati Medicare Ltd | Paonta Sahib

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Tirupati Group is one of the largest and fastest-growing company, providing end-to-end solutions from research to product launch with multiple manufacturing facilities based out of Paonta Sahib, a serene town based on the foothills of Himachal Pradesh, India. The group was founded way back in 2005 and has already reached a significant size of Rs. 500 Cr (approx. 80 MN USD).

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The group is highly diversified, catering to a variety of broad segments like Pharmaceuticals, Nutraceuticals, Ayurveda, and a very niche segment like Sports Nutrition.

Tirupati Medicare Limited is a leading-edge science and technologically advanced formulation manufacturing facility that holds the potential for substantial enhancements to health and to the practice of healthcare. It is sustained by trained and highly experienced teams of professionals including production managers, dedicated quality units, and logistical support; working constantly towards the multidimensional growth of the company.

Position: Manager Regulatory Affairs (Nutraceuticals)

Location: Paonta Sahib Himachal Pradesh, India

Job Description:

Roles and Responsibilities

  • Licensing and communication regarding the Nutra & Sports Nutrition defined by FSSAI.
  • Review of application for product approval, endorsement, License modifications with the center and State FDA/ FSSAI.
  • Co-ordination / Liasoning and visit to regulatory Authorities FSSAI, State FDA/ Legal Metrology, etc. for various product/facility approval.
  • To extend Technical support in solving imposed legal cases, in association with the legal department.
  • Review & preparation of Dossier for Export & Domestic Nutraceuticals.
  • Handling of FDA/market complaints, follow up with Quality for Investigation & compliance submission.
  • To review artwork/label for regulatory compliance in order to reduce FDA & Market complaints.
  • Co-ordination and visit to regulatory Authorities FSSAI for licenses, DCGI for FSC.
  • Training Cross-functional Team on new regulations implemented by FSSAI.

Desired Candidate profile

    • Strategic mindset and problem-solving skills
    • Talent for communicating, influencing, problem-solving and analytical skills
    • Analytical thought process
    • Excellent organizational skills, with the ability to facilitate & lead the team
    • Excellent communication and interpersonal skills
    • Team leading approach.
    • Project management & data interpretation skills
    • Ability to make & deliver process training sessions
    • Knowledge of domestic and international markets
    • Proficient with use of the Internet, MS Outlook, MS Office – including word, excel, and PowerPoint.

Qualification: B.ScMS/M.Sc in Food Technology, B.Pharma, M.Pharma

Experience: 2-5 Years

Salary: Negotiable

Contact Details:

careers@tirupatigroup.co.in, sheetal.sharma@tirupatigroup.co.in, rahul.dev@tirupatigroup.co.in

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