Regulatory Specialist, MSR Coordination-Senior
Site Name: India - Karnataka - Bangalore R&D
Posted Date: Sep 23 2019
Job Related Experience:
- 5 -7 years of experience inRegulatory Submission- Initial submissions, Variations, Renewals, for Europe, Rest of the World & US region markets
- Understanding and hands on experience on Product registration dossier/ overall CTD modules, extensive experience onModul-1, Module-2.3, Module-3
- Hands on experience in different types of certificates, declarations and Legalised documents - both QA & RA documents for Pharmaceutical product.
- Exposure in dealing various on-site stake holders.
- Experience in dealing with finished product manufacturing sites, stake holders for arranging technical documents required for regulatory submission.
- High attention to detail.
- Highly developed interpersonal, presentation and communication skills.
- Service-oriented attitude and ability to be a team player and interact effectively with all levels of personnel in an interdisciplinary and matrix environment.
- Computer proficiency, IT skills, the expertise and ability to work with web-based applications
- High level of flexibility and ability to prioritize work
- 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.
- 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.
- Liaise with market specific requirements suppliers (manufacturing sites, External Supply QA, LOCs) to obtain documentation in a timely manner.
- Update tracking systems & Ensure appropriate archival of MSR data package
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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