Manager, Cmc Vx Development Projects
il y a 1 semaine
Site Name:
Belgium-Wavre
Posted Date:
Mar
Are you seeking an opportunity where you can lead through influence using your expertise? If so, this Manager, CMC Vx Development Projects role could be an exciting opportunity to explore
This role will provide YOU the opportunity to progress YOUR career, these responsibilities include some of the following
Your responsibilities:
- Drives the CMC strategy, coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development and registration of new vaccines or lifecycle activities and maintenance of registered vaccines, in accordance with the applicable regulatory & scientific standards, taking into account the evolving regulatory requirements.
- Provides regulatory advice and guidance to the Technical Development Team and/or Technical Life-Cycle Team (TLCT), Implementation Committee, Specification Review Committee, Technical Review Board, CMC Expert Panel, and provides regulatory support to their partners in R&D, Quality Control, Manufacturing, QA and Supply.
- Ensures adequate interaction and partnership with the Global Regulatory Lead's team in order to define proper regulatory CMC filing strategy.
- Ensures adequate contribution during interactions with Worldwide regulatory authorities.
- Ensures, in a continuous improvement mindset, regulatory compliance is maintained and shares bestpractices and learnings within the CMC Regulatory teams and other impacted functions.
- Ensures, with management oversight, that all appropriate CMC regulatory aspects for clinical trials, product release and stability are in place, to avoid clinical holds, and to ensure continuity of market supply.
- Ensures all appropriate CMC regulatory aspects to support license maintenance and change control requests including transfer of supply within GSK or with a 3rd party are delivered to agreed timelines.
- Manages multiple projects and teams simultaneously and provides data assessment and conclusions within and across departments. Formulates novel approaches and influences people, systems and processes. Identifies risks associated with submission data and information packages. Contributes to, and leads (as required) the creation, maintenance and continuous improvement of CMC Regulatory processes, policies and systems.
Why you?:
Basic Qualifications:
- We are looking for professionals with these required skills to achieve our goals:_
- Bachelor's degree in Sciences or Medical Sciences
- Successfully managed multiple projects simultaneously.
- Sound knowledge of drug development and manufacturing and supply processes and may have a specialized area of expertise.
- Knowledge of CMC regulatory requirements.
- Demonstrated ability to handle global CMC issues through continuous change and improvement
Preferred Qualifications:
- If you have the following characteristics it would be a plus:_
- Master's degree or above in Chemistry, pharmacy, biological or closely related science advanced degree.
- Experience in Pharmaceutical industry or Research organizations, established in Regulatory Affairs and with demonstrated experience of leadership in a matrix environment.
- Sound knowledge of vaccines/biological products development, manufacturing and supply processes.
- Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.
_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
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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