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 :
[Confidential Information]
Website
www.swiss.in
