GlaxoSmithKline is looking to hire Regulatory Specialist MSR coordination Senior .Interested and eligible candidates can send their resume .GlaxoSmithKline plc is a British multinational pharmaceutical company headquartered in Brentford, England..The eligibility criteria as follows.
Vacancy details :
| Company Name | : GlaxoSmithKline |
| Department | :Regulatory Affairs |
| Designation | : Regulatory Specialist MSR coordination Senior |
| No. of Vacancies : | :NA |
| Location | :Hyderabad |
| Qualification | :Graduate |
| Experience | :05-07+ |
| Salary | :NA |
Job description:-.
- With minimal input from manager, executes agreed dossier strategy & manages multiple project assignments simultaneously; dossiers will range in complexity.
- Drive and lead assigned set projects/product portfolios.
- completes data assessment to ensure dossier is fit for purpose.
- Developing an understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global regulatory applications.Â
- Author, prepare, compile, finalise & coordinate as applicable – Module-1, Module-3 (as applicable signed Module-3 documents) Market Specific Requirements (MSRS)  package for regulatory submissions & Organise dispatch of MSRs. Identifies risks associated with submission data and information packages. Arrange samples for various regulatory submissions
- Coordinate and arrange clinical and non- clinical documents (Module-2, Module-4 & Module-5 documents) in liaison with Clinical & non-Clinical stakeholders for regulatory submission
- Identify issues that have business impact with relevant escalation process.
How to Apply :Â Click here for full details and Apply
