Freshers Vacancies at GSK – Apply Online For Regulatory Specialist Role
Welcome to GSK, a global healthcare company that is committed to helping people do more, feel better, and live longer. With a diverse portfolio of innovative medicines, vaccines, and consumer healthcare products, we strive to make a meaningful difference in the lives of people around the world. Join us in our mission to improve the quality of human life by exploring the exciting opportunities available at GSK.
Regulatory Specialist – Submissions Assembly
Bengaluru, India
Regulatory
384715
Job Description:
Job Purpose:
The Regulatory Submission Assembly – Level 1 role is to co-ordinate between multiple stakeholders/LOC, to obtain regulatory submission documents for preparation of quality dossier in agreed timeline and submissions to respective agencies with high quality.
Key Responsibilities:
- Drive the submission and delivery process with the Global Publishing team to ensure timely dispatch and archival of submissions as per the agreed timelines.
- Delivery of submission packages to agreed schedule and technical specification.
- Advise and assist authors with the preparation of submission content and use of GSK document management systems and procedures.
- Works across the functions and can work with stakeholders in development functions in provision of advice interpretation of relevant guidance’s, researching topics and resolving issues.
- Understanding of regulations, guidelines and developing procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global regulatory applications.
Job-Related Experience:
- 0-6 years of experience in Regulatory Affairs or related responsibilities.
- Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.
- Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
- Excellent written and verbal communication skills and ability to present information in a clear and concise manner.
- Ability to build effective working relationships and work in a matrix environment effectively.
- Excellent computer knowledge (e.g. MS Word, MS Excel, Adobe PDF, SharePoint, Internet Explorer, etc.) and preferably experience with the use of complex IT tools in a large organization.
- Ability to think flexibly in order to meet constantly shifting priorities and timelines.
Other Job-Related Skills/Background:
- Can communicate effectively in English.
- Has a strong sense of urgency, able to effectively prioritize such that key issues or emerging high priority matters are handled in a timely and effective way.
- Service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment.
- Highly developed interpersonal, presentation and communication skills with established internal and external networks.
- Ability to work carefully/independently under time constraints.
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