RA Officers/ Executives /Team leader @ Ciron
Drugs and Pharmaceuticals Pvt. Ltd
Job location: Jogeshwari
Designation: Officer / Sr. Officer /
Executive
Experience: 3years and above
Job Responsibilities:
- Compilation,
review and timely submission of error free registration dossiers under
CTD/ACTD/Country Specific for International market (CIS, LATAM, AFRICA &
ASEAN market).
- Co-ordinate with
various cross functional team members as well with various functions within
F&D, ADL and manufacturing locations for collecting technical data required
towards registrations / MOH / customer deficiencies.
- Keeping up to
date with changes in regulatory legislations and guidelines.
- Ensuring
compliance with regulations set by the regulatory agencies.
- Ensuring that
quality standards are met and submissions meet within stipulated timelines.
- Review of
Normative Documents (NDs) of products required towards registration in CIS
countries.
- Knowledge about
CMC section required for dossier compilation.
- Responsible for
compilation & review of quality documents like MMF, RM/FP SPCN, STP,
Stability Protocols & Report, Process Validation protocols & reports,
Analytical method validations.
- Liaise with
marketing for the finalizing the product pipelines and providing required
dossiers for submissions.
- Liasioning with
customers for contract manufacturing/loan licensing towards registrations of the
products.
- Responsible for
preparation of FDA documents for registration of new product, license for new
products (proforma), COPP data compilation & verification.
Interested Candidate can send their resumes
at hr.ho@cironpharma.com
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