Global Regulatory Affairs Manager
見る: 150
更新日: 16-11-2025
場所: Wavre Walloon Brabant
カテゴリー: マーケティング/ PR
業界: Gezondheidszorg
仕事内容
Posted Date: Dec 13 2021
’Be You’ at GSK
Uniting science, talent, and technology to get ahead of disease together
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022:New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients– so we deliver what matters better and faster; accountable for impact– with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
Job Title
Global Regulatory Affairs Manager
In this role you will…
Provide input to/manage regulatory activities in order to obtain Marketing Authorisations for commercial products as rapidly as possible, with the best possible label, and to maintain these authorisations.
Determine from a strategic and scientific perspective the content of relevant sections (technical/non-clinical (NC), clinical/labelling or procedural) of project/product specific documents submitted to regulatory agencies worldwide (eg. MAA/BLA, variations/sBLA, Q&A, scientific consultations, Paediatric Investigational Plans, etc.) and ensure that these documents meet high scientific standards and regulatory requirements. Responsible for one specific (clinical/labelling or technical/NC or procedural) section.
Provide support in compiling/write briefing documents for internal governing bodies and other relevant internal documents (eg Global Regulatory Plan, KMS, etc.). Responsible for one specific section (clinical/labelling or t/NC or procedural).
Provide regulatory input for one (or more, in agreement with his/her manager) specific sections of certain/all development stages of the project/product within a given product portfolio.
Ensure, from an RA perspective, the execution of the product development regulatory strategy in order to ensure a complete and rapid development of the asset, for a specific section (clinical/labelling or technical/NC or procedural).
Support the Global Regulatory Lead in providing robust regulatory advice and plans to the various project teams and advisory bodies to ensure that the business needs are in compliance with regulations and/or regulatory advice received from the agencies.
The GRA Manager will be part of a global team working to define the world-wide regulatory strategy for key assets in the vaccine pipeline. We support Research and Development teams as well the commercial vaccine strategy by contributing with regulatory expertise, engagement, and patient focus to drive the lifecycle management and new marketing authorization opportunities.
This job opportunity is also open for relocation.
Why you?Qualifications & Skills:
Master’s Degree or PhD in scientific discipline
4+ years significant experience in regulatory affairs
English proficiency
Ability to coordinate and execute regulatory strategy for a given project/product.
Strategic thinker – ability to provide input into regulatory strategy and evaluate potential impact on overall project/product strategy.
Preferred Qualifications & Skills:
Good presentation skills to ensure that GSK Vaccines regulatory voice is clearly articulated and heard in the various cross functional teams.
Ability to identify and escalate issues to the GRL and to propose mitigation strategies, maximize opportunities, with proven ability to develop collaborative relationships and have high impact and influence
Good influencing skills.
Support the Global Regulatory Lead to ensure regulatory input is provided to other GSK divisions or to regulatory agencies, as appropriate.
Quality mindset
Inclusion & Diversity at GSK:
Inclusion and diversity at GSK are key for our success. Here, you will thrive through bringing your unique experiences to both our company and the recruitment process. We want you to be you, feel good and keep growing your career.
GSK is an Equal Opportunity and Affirmative Action Employer. Applicants will travel through a transparent recruitment journey that adheres to all required employment standards and regulations. Beyond this, we commit to our values of integrity and respect towards every applicant.
We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team (contact email) to further discuss this today.
We will request equal opportunities information from you and whilst disclosure is optional, we encourage you to be open, enabling us to monitor the inclusivity of our recruitment practices for the benefit of everyone. Your data will remain confidential, is never shared with our Hiring Managers and never affects the status of your application.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.
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.
締切: 31-12-2025
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