Swiss Parenterals Ltd Recruitment 2020. Swiss Parenterals Ltd Notification fulldetails Below. Swiss Parenterals Limited is company based in Bavla, Ahmedabad. Our product range includes Sterile Dry Powder Injectables, Liquid Injectables in Vial and Ampoule.
Important Vacancy details:
- Post Name: RA Officer / Executive / Sr. Executive
- Education : B.Pharma/ M.Pharma
- Experienced:01 to 6 years
- Location: Ahmedabad( Prahlad Nagar )
- Salary : NA
- Openings :NA
- Contact:Anita Bhatt-9978976432
- Email id: firstname.lastname@example.org
Note:If Intrested Candidates Can Submit the Resume Above Email id.
Job Description: We have requirement for the post of RA Officer / Executive / Sr. Executive in Swiss Parenterals Ltd !
- 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.
Selection Process: The selection will be on the basis of Interview.