Director Vaccines Development Cmc
il y a 1 semaine
Site Name:
Belgium-Wavre, Italy
Posted Date:
Jan 9 2023
Director, Vaccine Development CMC:
We are looking for a highly skilled regulatory professional to provide leadership and guidance whilst working cross functionally to maximise opportunity within our vaccine development.
Job Purpose:
Key Responsibilities include, but are not limited to:
- Provide leadership and direction to CMC regulatory scientists within his/her team, including management of workload and priorities
- Together with line management, recruit, retain and develop CMC regulatory scientists (Senior Managers, Managers and/or Specialists) so to achieve quality output ("Right First Time"), accountability and recognition across the Organization
- Develop CMC Subject Matter Experts network and sharing of expertise across his/her team and together with other CMC regulatory units across GRA and beyond
- Accountable for CMC regulatory affairs representation to specific CMC development Teams (e.g. TDT, CMC expert panel, specification committee), thus ensuring CMC regulatory strategy, scientific and procedural input required for advancement of the Vaccine development program assigned to his/her team.
- Accountable for defining the CMC regulatory submission strategy for his/her specific development asset; to be done in partnership with Global Regulatory as required.
- Accountable for the preparation, authoring and timely submission of high quality CMC development dossiers (eg CTA, IMPD, IND), including interactions with and management of contributing departments within GRA (eg content delivery) or outside (TRD, Quality, manufacturing etc).
- May act as the point of contact for Regulatory Agencies for asset(s) (projectspecific)
- Provide support to the Global Regulatory Lead (GRL) for key CMC regulatory activities pertaining to a development product (eg attendance to VDT if required, CMC input for Global Regulatory Plan, etc) and to product registration to achieve ontime approvals of GSK Vaccines submissions for the asset(s).
- Delivers CMC regulatory strategy to support major inspections (eg PAI's) or quality incidents (PIRCs).
_ Why You?_
Required Qualifications:
- We are looking for professionals with these required skills to achieve our goals:_
- Bachelors degree, or equivalent, in life sciences
- Detailed knowledge of drug development and manufacturing and supply processes and may have a specialized area of expertise.
- Detailed working knowledge of complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.
- Proven project management and multitasking skills.
- Track record of effective influencing and negotiating with regulatory agencies, industry bodies, and personnel in a variety of settings.
- Demonstrated ability to handle complex global CMC issues through continuous change and improvement.
Preferred Qualifications:
- If you have the following characteristics, it would be a plus:_
- Masters degree.
- Regulatory affairs certification
- 8+ years in Pharmaceutical industry or Research organizations, with 5+ years in Regulatory Affairs and with demonstrated experience of team leadership
- Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.
- Has identified opportunities to further educate colleagues and formulate approaches to most effectively meet new requirements.
- Proven experience in supervising and training staff within an organisation.
_ 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.Find out more:
Annual Report 2021
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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