GSK looking for Regulatory Specialist

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Post : Regulatory Specialist - Submissions Assembly

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. Supports Global Regulatory by producing appropriate components for global regulatory dossiers with minimal input from line manager.

Key Responsibilities
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
• 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.

Candidate Profile
• 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 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.

Additional Information
Experience : 0-6 years of experience
Location : Bengaluru
Req ID : 384715
Industry Type : Pharma / Healthcare/ Clinical research
End Date : 30th December, 2023