Tirupati Group is one of the Fastest Growing Pharma Company founded in 2005, has surpassed revenue of Rs 500 Crore. Tirupati Group is diversified in Pharma, Nutraceuticals, and Ayurvedic and a very niche segment of Sports Nutrition.

Tirupati Group is having 3 Openings for AGM/Sr Manager Regulatory Affairs in Pharma, Ayurveda, and Nutraceuticals

1. Position: Asst General Manager/Sr Manager – Pharma

  • Review of updates on DCGI, CDSCO, and submission of suggestions to the regulators for change.
  • Co-ordination and Liasoning to regulatory Authorities DCCGI/CDSCO/ State FDA/ Legal Metrology etc. for various product/facility approval.
  • Review and Preparation for Dossier for Export and Domestic (Pharma).
  • Preparation of response of ADR under Pharmacovigilance guidelines by PvPI
  • Co-ordination and Liasoning to regulatory Authorities DCCGI/CDSCO/ State FDA/ Legal Metrology etc. for various product/facility approval.

2. Position: Asst General Manager/Sr Manager – Ayurvedic

  • Review and preparation of the dossier for Export and Domestic of Ayurveda Products for ASEAN, CIS. ROW, LATAM, US, EU and UK market& its endorsement with “Embassy followed by product registration “
  • Having sound knowledge of Indian regulations( Ayush), API, Herbs and related references, legal metrology, EXIM policy ( Export-import policy of India), schedule -T, Schedule -M
  • To have interactive communication with Cross-Functional Team i.e. R&D, Legal, Quality, Production, Business Development
  • Day to day communication with the companies/ clients for their queries related to the various regulatory guidelines and product compliance as per the regulation.
  • To review artwork/Label for D&C Act -1940, compliances to reduce FDA and Market complaints on artwork-related issues.
  • Co-ordination / Liasoning and a visit to regulatory Authorities FSSAI/CDSCO/ Ayush/State FDA/ Legal Metrology etc. for various product/facility approval.

3. Position: Asst General Manager/Sr Manager – Nutraceuticals

  • Licensing and communication regarding the Food products, i.e. including 08 categories of nutraceutical food products 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 of imposed legal cases, in association with the legal department.

Desired Candidate Profile:

  • Capable of Developing Strategies and Resolve Problems
  • Communication, Analytical, Influencing Decisions, and Problem Identification and Solving Skills
  • Leadership and Organizational Skills, Good on IPR Skills
  • Ability to interpret and Manage Projects
  • Capable of Prepare and Deliver Training Sessions
  • In-Depth understanding of Domestic and International Markets and Trends
  • Well versed with Computer, MS Office and other related Applications

Location: Paonta Sahib, Himachal Pradesh

Qualification: B.Sc- Chemistry/Food Technology, B.Pharma, MS/M.Sc/M.Pharma, BAMS

Experience: 14-20 Yrs

Salary: Negotiable

Contact Details: 

HR

+91-9816700121

careers@tirupatigroup.co.in


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