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Require AGM, Senior Manager at Tirupati Medicare Limited

Require AGM, Senior Manager at Tirupati Medicare Limited

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 :Paonta Sahib, HP
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th September, 2020

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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