Submission Lead, Submission Delivery Excellence Investigational
- Wavre, Brabant Wallon
- CDI
- Temps-plein
Find out more:Position summaryThis role offers an exciting opportunity to lead the preparation and delivery of regulatory submissions for investigational products. You will collaborate with global teams, ensuring submissions meet regulatory requirements and timelines. We value candidates who are detail-oriented, proactive, and skilled at working in a matrix environment. Your contributions will directly support the development of innovative solutions that improve health outcomes worldwide.Responsibilities- Coordinate and deliver regulatory submissions for investigational products across global markets.
- Implement submission strategies, ensuring compliance with regulatory guidelines.
- Collaborate with cross-functional teams to create and maintain detailed submission plans.
- Monitor submission progress, identify risks, and resolve issues to ensure timely delivery.
- Provide guidance on regulatory processes and requirements to internal teams.
- Maintain high-quality standards and ensure submissions are accurate and complete.Qualifications & SkillsBasic Qualifications
- Bachelor’s degree in life sciences, pharmacy, or a related field.
- At least 1 year of experience in regulatory affairs, including investigational product submissions.
- Strong organizational skills and attention to detail.
- Excellent written and verbal communication skills in English.
- Ability to work effectively in a matrix environment and manage multiple priorities.Preferred Qualifications
- Master’s degree in life sciences or pharmacy.
- Experience with global regulatory submissions and knowledge of international guidelines.
- Familiarity with clinical trial applications and investigational product lifecycle management.
- Proficiency in project management and stakeholder collaboration.
- Knowledge of regulatory systems and tools.#LI-GSK#GSKVaccinesIf 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 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.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.