HomeHead/VP/CEO/President/GMAsst General Manager/Sr Manager - Regulatory Affairs - Tirupati Medicare - Paonta...

Asst General Manager/Sr Manager – Regulatory Affairs – Tirupati Medicare – Paonta Sahib, HP


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: 




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