Tirupati Medicare Limited - Openings in Regulatory Affairs(Pharma / Nutra / Ayurveda) - Apply Now

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