RA Officer / Executive / Sr. Executive @ Swiss
Parenterals Ltd
Job description:
·
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 ACTD, CTD & country specific format according to guidelines of various
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.
Candidate profile:
Having experience
in latam and CIS regions
Will be reporting
to Director.
Experience: 1-6 yrs
Qualification:
B.Pharm / M.Pharm
Contact Person:
Anita Bhatt
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