Regulatory Affairs Project Lead

Roles and Responsibilities : -

• Collect and coordinate information and compile regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy.
• Preparation & compilation of dossier in CTD, ACTD, ECTD & country specific format according to guidelines of countries.
• Response to query / deficiency / Notice of Deficiency raised by Drug Regulatory Authority or technical representative.
• Coordination with Quality Control, Quality Assurance and Production department for regulatory documents.
• Timely compile documents for license renewals, update and re-registrations.
• Maintain regulatory files / database and chronologies in good order.
• Establish and maintain system for tracking drug product registration, samples submitted to agencies or partners.
• Compilation of Technical Dossier for Tender participation.
• Review changes to existing products and SOPs to define the requirements for regulatory submissions.
• Review of technical documents like BMR, Stability protocol & report, specification and method of analysis, process validation protocol and report required for dossier compilation.
• Initiation and review of drug product artworks like Package Insert, Summary of Product characteristics (SmPC), label, foil and carton for compliance with regulatory requirements.
• Must Have dossier submission exposure in ROW and EU market.
• Good exposure of Team handling & day to day report
• Sound knowledge of ICH and country specific guidelines
• Excellent skill in Deficiency response preparation.
• Excellent knowledge of Technical documents review.
• Other activities assign by RA Head.
• Must have experience in Parenterals Product

Note : - Only local candidate highly preferable.

Do not apply freshers.

Education : B.Pharm / M.Pharm

Experience : 2Years to 10 Years

Location :

Sindhu Bhavan, Ahmedabad

e-mail : hroffice1@swiss.in

Website

www.Swiss.In