AGM / Sr. Manager – Regulatory Affairs

from 14 to 20 year(s) of Experience
Paonta Sahib

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.

Perks and Benefits 

Best In Industry

Salary: Not Disclosed by Recruiter

Industry:Pharma / Biotech / Clinical Research

Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category:Drug Regulatory Affairs/Documentation

Role:Regulatory Affairs Manager

Keyskills

Desired Candidate Profile

Please refer to the Job description above

Education-

UG:BAMS - Any Specialization, B.Pharma - Pharmacy, B.Sc - Food Technology, Chemistry

PG:M.Pharma - Pharmacy, MS/M.Sc(Science) - Any Specialization

Doctorate:Ph.D - Pharmacy, Chemistry, Dairy Technology, Food Technology

Company Profile

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).

The group is highly diversified, catering to a variety of broad segments like Pharmaceuticals, Nutraceuticals, Ayurveda and a very niche segment like Sports Nutrition.
View Contact Details+

Recruiter Name:Monika Taluja

Contact Company:Tirupati Medicare Limited

Telephone:9816700121

Email :careers@tirupatigroup.co.in

Address :Nahan Road, Surajpur,, Ponta Sahib, Sirmour,Himachal Pradesh, SIRMAUR, Himachal Pradesh - 173025,India

Website:https://tirupatigroup.co.in/

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