Regulatory Project Manager
il y a 1 semaine
Site Name:
Belgium-Wavre
Posted Date:
Mar 6 2023
You will be responsible for the CMC regulatory activities in the late phase development and/or commercial lifecycle management of GSK products.
Key responsibilities:
- Responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities.
- Responsible for CMC strategy development, with managerial support, for CMC submission documents to support marketed product lifecycle management activities in accordance with the applicable regulatory & scientific standards.
- Ensures all appropriate CMC regulatory aspects for product release are in place, to ensure continuity of market supply. Ensures information submitted lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality flexibility with mínimal unanticipated questions.
- Works in crossfunctional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy.
- Maintains high quality standards and seeks to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
- Ensures regulatory compliance is maintained and shares bestpractices and learnings within the CMC Regulatory teams and other impacted functions.
- Engages in CMC Subject Matter Expert activities internally (for increased compliance, harmonisation and efficiency).
- Will sometimes deliver CMC regulatory strategy to support major inspections (eg PAIs) with managerial support.
Why You?
Basic qualifications:
- Master's degree or above in Chemistry, pharmacy, biological or closely related science advanced degree.
- Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience with direct involvement in regulatory submission preparation in late phase development and/or marketed product life cycle submissions.
- Sound knowledge of drug development, manufacturing processes and supply chain and may have a specialized area of expertise.
- Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for marketed products.
- Good time management skills with the ability to effectively plan, prioritise and coordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
Preferred qualifications**:
- Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Has broadened own knowledge base across regulatory functions to understand wider implications of emerging issues across projects.
- Experience in influencing and negotiating with company personnel and with regulatory agencies in a variety of settings.
- Strong interpersonal, presentation and communication skills with established internal networks.
- Proactively seeks out and recommends process improvements
- Proven ability to develop and implement regulatory strategies and evaluate their potential impact on overall project/product strategy.
- Demonstrated ability to handle global CMC issues through continuous change and improvement
- Developing experience in major post approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management).
Why GSK?
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.
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.Li-GSK
VxRD*VaccinesRD
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.
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