Regulatory Submission Lead

GSK; Belgique; Sur place; EUR 58 000 - 97 000; Plein temps

Résumé du poste

GSK in Belgium seeks a Regulatory Submission Lead to independently support regulatory registration requirements and coordinate submission packages within the Veeva Vault system. The role includes mentoring new team members and collaborating with global and local teams to meet health authority deadlines.

You will review documents for CPP, GMP certificates, legalisation and regulatory samples, working with cross-functional teams to ensure compliant, timely submissions across markets.

Qualifications

• Bachelor's degree or higher in biological or healthcare science.
• Minimum several years of experience in regulatory submissions and health authority interactions.
• Strong understanding of registration procedures, guidelines and timelines.
• Experience interacting with Health Authorities, particularly Belgium Health authority.
• Ability to coordinate cross-functional teams and mentor colleagues.

Responsabilités

• Deliver regulatory registration requirements for assigned submissions per dossier strategy.
• Coordinate preparation and timely delivery of documents requested by health authorities and third parties.
• Collaborate with cross-functional teams (CMC, Clinical, Nonclinical) to meet regulatory expectations.
• Mentor and train new team members within the submission group.
• Review peers' deliverables and propose process improvements to regulatory workflows.
• Engage with regulatory agencies to address issues and ensure compliance.

Connaissances

Agile Planning

Business Acumen

Change Management

Digital Fluency

Learning Agility

Problem Solving

Regulatory Strategies

Formation

Bachelor's degree or higher in biological or healthcare science

Outils

Veeva Vault

Description du poste

Please note that this is a 'internal job posting' link, intended for GSK/ViiV employees only. Contingent Workers should check with the recruiter of the Job Requisition to confirm whether the job is open to contingent workers and to obtain the correct job posting hyperlink.

Please note it is your responsibility to notify your manager if you are interested in applying to an open position prior to the interview taking place. Please refer to your local policy for more information and guidelines.

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 packa