Job Opportunities in Belgium


September 30, 2024

GSK

Wavre


Director, Regulatory Affairs - Specialty

Site Name: UK – London – New Oxford Street, Stevenage, Wavre
Posted Date: Sep 30 2024

Job Purpose
Ensure the development of appropriate regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy. This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data.

Key Responsibilities
Accountable to GRL and Global Regulatory TA Head for development of appropriate regional and/or global regulatory strategy(ies) and for delivery according to plans. The Regulatory Director may be the single point of contact on assigned asset(s), responsible for regional and global regulatory strategy(ies). In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with at least the local regulatory agency. Work closely with local / regional commercial team to secure best possible labelling commensurate with the available data. Lead interactions with local / regional regulatory authorities.

  • Ensure the regulatory strategy will deliver the needs of the local region(s), taking in to account the needs of other regions globally
  • Implement the regional strategy(s) in support of the project globally
  • Lead regulatory interactions and the review processes in local region
  • Ensure appropriate interaction with regional commercial teams in local region
  • Ensure compliance with regional requirements at all stages of product life from C2MD
  • Ideally able to advocate persuasively approaches to senior leaders in GSK and in Health Authorities
  • Capable of providing assessment of potential in license molecules

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor’s degree
  • Experience in Regulatory Affairs within a pharmaceutical organization
  • Experience working with Global Health Authorities and submissions for Phamaceutical products

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Ph D or Masters’ degree in life sciences or pharmacy
  • Strong technical knowledge required to be able to assess regulatory compliance of products
  • Ability to interact with regulatory officials and support advocacy initiatives

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.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@gsk.com or 0808 234 4391.

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Important notice to Employment businesses/ Agencies
GSK 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.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.

Latest Job Opportunities


October 28, 2024

KEA European Affairs
Research intern – 2024/2025

Bruxelles Ixelles

INTERN

View Details

October 28, 2024

Smals
Software Architect Java - Angular

Brussels

FULL TIME

View Details

October 28, 2024

Smals
IT Service Coordinator

Brussels

FULL TIME

View Details

October 28, 2024

Smals
Web Copywriter

Brussels

FULL TIME

View Details

October 28, 2024

Mutualité Chrétienne
Un Responsable régional ALTEO (H/F/X) pour sa régionale de Bruxelles

Brussels

OTHER

View Details

Similar Jobs


October 24, 2024

GSK
Director, Value Engineering and Program Management

Wavre

OTHER

View Details

October 17, 2024

Lilly
Associate Director, Clinical Drug Supply, Clinical Trial Commercial Product – Buyer Planner

Mont-Saint-Guibert

FULL TIME

View Details

October 24, 2024

GSK
Associate Director, Real World Analytics Oncology

Wavre

View Details

October 22, 2024

GSK
Associate Director, Pharmacovigilance Operations – ICSR Management

Wavre

View Details

October 11, 2024

GSK
Director, Global Real-World Evidence & Health Outcomes Research-Modelling Vaccines

Wavre

View Details

October 11, 2024

GSK
Director, Global Real-World Evidence & Health Outcomes Research Scientist-Neisseria

Wavre

View Details

New Jobs from This Company


October 27, 2024

GSK
Associate Scientist - Expression Proteins

Rixensart

INTERN

View Details

October 27, 2024

GSK
Associate Scientist Expression mRNA

Rixensart

INTERN

View Details

October 26, 2024

GSK
HR Business Partner Vaccines Manufacturing, Senior Manager

Wavre

View Details

October 25, 2024

GSK
Validation Lead

Wavre

OTHER

View Details

October 25, 2024

GSK
Early Talent Lead

Wavre

View Details