The Regulatory Specialist, Submission Technical Support is a regulatory operations specialist who provides submission technical support to regulatory authors. The team’s accountabilities include editing and format-checking regulatory documents, ensuring that all documents are prepared as specified by GSK delivery teams (time and content) and are compliant with appropriate submission standards. The group is also responsible for timely delivery of CMC compliant regulatory submission packages to Regulatory Authorities by supporting the end-to-end processes in place for clinical applications and major submissions, providing expert guidance on technical requirements to R&D Project Teams, and planning and directing of submission support tasks in collaboration with other Submission Production team members.
Key responsibilities:
Deliver complex submission packages independently, to agreed schedule and technical specification
Support creation and management of content plans - system structures holding documents for a submission
Assemble, link and publish submission packages that meet Regulatory Authority technical standards and GSK requirements and schedules
Check the format of the MS Word documents ensuring GSK requirements and standards are met
Identify and resolve issues with source documents, working with authors and requestors as necessary to rectify any problems that prevent completion of the publishing job
Advise and assist authors with the preparation of submission content and use of GSK document management systems and procedures, including more complex or non-routine ones
Maintain knowledge of relevant Regulatory Authority rules and GSK standards associated with submission format
Participate in implementation of publishing working practices and procedures aimed at simplifying processes and increasing quality
Regularly interact with publishing staff globally
Why you?
Basic Qualifications:
Minimum Bachelor’s Degree – Preferably in a scientific or technical field
Fluency in English, both written and spoken communication
Experience in Document Preparation and Formatting using MS Word and associated tools
Technical Proficiency – Strong knowledge of common computer applications (e.g., MS Office, Adobe Reader) and, ideally, experience with complex IT tools in large organizational settings
Effective Interpersonal and Communication Skills – Strong focus on customer service and collaboration
Organizational and Prioritization Skills - Proficient in managing a broad spectrum of tasks and effectively setting priorities to meet deadlines
Quick Learner - Proven ability to rapidly acquire and integrate new knowledge
System Adaptability - Proficient in quickly adopting and navigating new tools and technologies
Adaptability to Change - Agile in adjusting to shifting priorities and dynamic environments
Detail-Oriented Under Pressure - Ability to maintain accuracy and attention to detail in time-sensitive situations
Collaborative in Matrixed Environments - Effective team player who thrives in cross-functional organizational structures
Preferred Qualifications:
Data Analytics Proficiency in MS Excel
Process Improvement Mindset – Strong critical thinking skills to enhance efficiency
Background in Publishing Electronic Submissions for Regulatory Authorities
Hands-on experience with tools such as Veeva Vault, Adobe Acrobat Professional, SharePoint, Documentum, Citrix, and Remote Desktop
Professional experience in Regulatory Affairs or related fields
Why GSK?
At GSK we offer a wide range of additional benefits:
Career at one of the leading global healthcare companies
Hybrid work (2/3 days per week from the office)
Contract of employment
Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
Life insurance and pension plan
Private medical package with additional preventive healthcare services for employees and their eligible
Sports cards (Multisport)
Possibilities of development within the role and company’s structure
Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
Supportive community and integration events
Modern office with creative rooms, fresh fruits every day
Inclusion at GSK:
As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at [email protected] to discuss your needs.
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Why GSK?
Uniting science, technology and talent to get ahead of disease together.
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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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