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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