Regulatory Affairs Associate Director

We’re excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we’re building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us, it’ll be one of the healthiest workplaces in the world, with best-in-class tech and bright, light spaces to help us thrive. We are looking for a talented Manager/Associate Director with strong global regulatory affairs knowledge/experience and interpersonal skills to join our GSK Specialty Therapeutic Group, Global Regulatory Affairs team.
As a valued member of the Regulatory Matrix team and the asset project teams, you will be empowered to develop appropriate regional regulatory strategy(s) and ensure their execution for assigned assets, consistent with the Medicines Development Strategy. With your strong regulatory expertise and communication/negotiation skills, you will provide regulatory strategic leadership and support for assigned asset(s) in the Pharmaceutical R&D portfolio and life cycle management, for regions outside US, with focus in EU, China, Japan and Emerging Markets.
You will ensure the development of appropriate regional regulatory strategy and its execution for assigned asset(s) consistent with the Medicines Development Strategy. This goal to be achieved as a component of an overall global regulatory approach, ensuring compliance with both internal GSK process/policy and with regional regulatory requirements.
We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Lead interactions with local/regional regulatory authorities.
Proactively develop regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globally.
Implement the regional strategy(s), and lead regulatory interactions and the review processes in the local region
Ensure appropriate interaction with global/regional counterparts and commercial teams in the local region
Ensure compliance with global/ regional requirements at all stages of product life
Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset
Work closely with the local/regional commercial team (s) to secure the best possible labelling commensurate with the available data.
Bachelor’s degree or preferably PhD in biological or healthcare science
Capable of leading regional development, submission and approval activities in local region(s)
Ability to make sound decisions and in doing so, the job holder will use a range of sources, and weigh benefits and risks, before making important decisions. Demonstrate a constant focus on improving performance and excellence in all tasks. Seeks to raise levels of performance by establishing or improving process
Capable of identifying project or team issues in advance and seeking necessary help and support to resolve. Ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Ability to recognise potential long-term issues for projects.
Experience of all phases of the drug development process in regulatory affairs
Good communication skills, especially in writing. Capable of identifying project or team issues in advance and seeking necessary help and support to resolve. Ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Ability to recognise potential long-term issues for projects.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. 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. 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).
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. 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. recruitment@gsk.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. 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.
#