Require AGM, Senior Manager at Tirupati Medicare Limited
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).
Post : AGM / Sr. Manager - Regulatory Affairs
Job description
Person in-charge will lead the Regulatory affairs team responsible for managing and upkeep of all Regulatory requirements for Pharma/Nuta/Ayurveda products being manufactured in Tirupati Group.
KRAs for Pharma Section :
• Review of updates on DCGI, CDSCO and submission of suggestion 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.
KRAs for Nutra Section :
• 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 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 legal department.
KRAs for Ayurveda Section :
• Review and preparation of 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 visit to regulatory Authorities FSSAI/CDSCO/ Ayush/State FDA/ Legal Metrology etc. for various product/facility approval.
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 power point.
Additional Information
Experience : 14 to 20 year(s) of Experience
Qualification : B.Pharm / M.Pharm / MSc / Ph.D / BSc
Location :
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th September, 2020
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