International Regulatory Affairs - Pharmaceutical Business
KK Consulting Services
Roles & 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 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.
- Preparation of regulatory documents like Declarations, manufacturer authorization for regulatory submission
- Co-ordinate for the sample requirement and dispatch for tender and drug product registration
- Preparation and updation of tracker system for dossier submission, product registration and samples
- Responsible for timely registration of the facility
- Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products
- Actively participate in evaluation of regulatory compliance of document /product/ process/test methods changes
- Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required.
- Product Permit
- Food & Drug Related work
- Renewal of licence
- WHO GMP work with CDSCO
- Product Permission
- Candidates should have experience in the Pharmaceutical industry as well.
- Prefer Candidates from Ahmadabad, Gujarat / proximity.
- NO flexibility on the given Experience and salary requirements.
- Person can be of taken as Asst. Manager or Sr. Executive, depending on the profile.
- Check for stability. Avoid frequent Job hoppers
- Recruitment Stages:1) CV Shortlisting 2) F2f with Hiring Manager 3) HR Discussion
- Candidate should be comfortable to work in a 2 year bond.
- ONLY Males candidates required
Many people view a job change as a way of promoting themselves to a better position. And in most cases, we at KK Consulting services would agree. However, you should always be sure that your new job offers you the means to satisfy your values. While there's no denying the strategic virtues of selective job changing for the purpose of career leverage, you want to make sure the path you take will lead you where you really want to go and want to achieve in your life.
At KK Consulting services, the "right" job is one in which your values are being satisfied most effectively. If career growth and advancement are your primary goals, and they're represented by how much you earn, then the job that pays the most money is the "better" job.
Telephonic Interview Available
- Telephonic interview are scheduled for this job opening.
- Interested Candidates are requested to apply and get recruiter contact number for telephonic interview.
- Candidates can call recruiter on given contact to start telephonic interview during working hours.
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