Regulatory Submission Lead

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Job Purpose:

The Regulatory Submission Lead independently supports regulatory registration requirements, such as Certificates (like but not limited to certificate of Pharmaceutical Product (CPP), Good Manufacturing Practice certificates (GMPc), Seen letters, legalisation and, regulatory samples, …),for submission activities. This includes authoring, reviewing, providing registration requirements and compiling dossiers for assigned deliverables in line with health authority regulations and GSK policies and processes. The position holder works with the Submission teams, Local Operating Company contacts, Global Regulatory Strategy or Functional Teams (or equivalent) to coordinate and prepare submission packages within the Veeva Vault system.

The position holder will also include mentoring and training new team members.

Key Responsibilities:

• Responsible for independently delivering regulatory registration requirements (CPP, GMP, Seen, legalisation, regulatory samples…), for assigned submissions as per agreed dossier strategy to the Submission teams, Local Operating Company contacts, Global Regulatory Strategy or Functional Teams (or equivalent), by working collaboratively with functional teams (e.g., CMC, Clinical, Nonclinical, etc.) & ensuring adherence to established timelines in assigned markets.
• Manage complex regulatory registration requirements, including those requested directly from regulatory agencies, manufacturing sites or third-party service providers. This includes providing manufacturing site support to meet regulatory expectations.
• Independently prepare, coordinate and ensure timely delivery of documents requested from health authorities , legalisation providers, manufacturing sites or third parties.
• Collaborates with staff across various functions and demonstrates the ability to engage with senior-level process development teams by providing advice, interpreting relevant guidelines, conducting research, and resolving complex issues. Possesses comprehensive knowledge of GSK processes and workflows, offering training, consultation, and tailored solutions both within and beyond the department.
• Serve as a reviewer for peers deliverables and propose improvements to regulatory processes, policies, and systems, thereby driving efficiency & innovation.
• Engage with Regulatory Agencies to address and resolve issues within their areas of responsibility.

Why You?

Basic Qualifications:

• Education: Bachelor’s degree or higher in biological or healthcare science.
• Preferably 5 years of experience with a strong understanding of industry, drug development, and R&D processes.
• Excellent organizational, communication, and interpersonal skills, with a focus on delivering high-quality results under tight deadlines.
• Communicate effectively with internal and external GSK stakeholders on project- and policy-related matters with minimal managerial supervision, ensuring the best outcomes for the organization.
• Demonstrates a strong understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications.

• Experience interacting with Health Authorities, particularly Belgium Health authority

Preferred Qualifications:

• In-depth knowledge of regulations, guidelines, and policies for pharmaceutical and vaccine registration and manufacturing.
• Proficient in using digital tools including AI, Veeva Vault systems to ensure efficient and compliant submission deliverables.
• Skilled in interpreting global regulatory requirements and providing expert guidance based on recent GSK experience.
• Adaptable and proactive in managing workloads, priorities, and timelines while effectively collaborating in a matrix environment.

#LI-GSK

Skills

Agile Planning, Business Acumen, Change Management, Digital Fluency, Learning Agility, Problem Solving, Regulatory Strategies

Belgium Salary Range / Fourchette salariale – Belgique: EUR 57,900 to EUR 96,500The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.Le salaire de base mensuel brut minimum pour les nouvelles recrues à ce poste est indiqué ci dessus pour chaque lieu applicable. Ce salaire de base mensuel brut minimum tient compte de plusieurs facteurs, notamment les compétences, l’expérience et le niveau de formation du/de la candidat(e), ainsi que le taux du marché pour le poste. En outre, ce poste peut donner droit à un bonus annuel ainsi qu'une éligibilité pour participer à notre programme de long term incentive basé sur des actions, en fonction du niveau du rôle. Des informations plus détaillées sur l’ensemble du package salarial seront fournies au cours du processus de recrutement. Ce poste étant ouvert à des candidat(e)s basé(e)s dans plusieurs pays, des fourchettes de salaire sont également indiquées pour certains lieux. Les fourchettes salariales pour d'autres localisations sont mentionnées parce que certains marchés ont des lois en matière de transparence salariale qui imposent que les informations sur les salaires soient affichées dans les offres d’emploi, et que ces pays sont des lieux potentiels pour ce poste. Si aucune fourchette salariale n’est indiquée dans l’offre d’emploi pour un lieu ou un pays spécifique, la rémunération correspondante sera discutée au cours du processus de recrutement. Veuillez noter que les salaires varient selon le pays en fonction des compétences, de l'expérience, du niveau de formation du/de la candidat(e) et du taux du marché pour le poste. Les offres sont généralement faites dans la fourchette annoncée en fonction des compétences, de l'expérience et des qualifications du/de la candidat(e), la partie haute de la fourchette étant généralement réservée aux profils très expérimentés ou à des circonstances exceptionnelles répondant à ces critères.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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