Regulatory Manager/Associate Director – Therapeutic Groups

Job title:

Regulatory Manager/Associate Director – Therapeutic Groups

Company

GlaxoSmithKline

Job description

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 create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.Discover more about our company wide benefits and life at GSK on our webpageIn this role you will

• 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.

Why you?Basic Qualifications & Skills:We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree or preferably PhD in biological or healthcare science
• Capable of leading regional development, submission and approval activities in local region(s)
• Knowledge of clinical trial and licensing requirements in all major countries in the region and ideally knowledge of other key Agency processes globally.
• 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. Challenges and questions ways of working to seek improved process. 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.

Preferred Qualifications & Skills:Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Experience of all phases of the drug development process in regulatory affairs
• Good communication skills, especially in writing. Capable of delivering key communications with clarity, impact, and passion
• Knowledge of relevant therapy area, and ability to further develop necessary specialist knowledge for the product or area of medicine
• Ideally good listening and comprehension skills; proactive in identifying potential issues and escalating them accordingly
• Ability to foster strong matrix working. Facilitates dialogue between team and matrix members to contribute their ideas. Capable of developing and recommending strategies for change.
• 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.

Closing Date for Applications – 21 June 2024 (COB)Please take a copy of the Job Description, as this will not be available post closure of the advert.
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. The information that you have provided in your cover letter and CV will be used to assess your application.At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. 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. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together.Find out more:.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 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 and scroll to the Careers Section where you will find answers to multiple questions we receiveAs 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/ AgenciesGSK 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. 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Expected salary

Location

Brentford, Greater London – London

Job date

Sun, 09 Jun 2024 07:21:45 GMT

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