Tirupati Medicare Limited - Openings in Regulatory Affairs(Pharma / Nutra / Ayurveda)
AGM / Sr. Manager - Regulatory Affairs(Pharma/Nutra/Ayurveda)
@ Tirupati Medicare Limited
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.
Required 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.
Send CV to careers@tirupatigroup.co.in
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