Regulatory Affairs Manager

Job content

Site Name: UK - London - Brentford

Posted Date: Jun 20 2022

Regulatory Manager

We have a great new opportunity for a Regulatory Manager in UK & Ireland Regulatory leading a team responsible for a portfolio of products across both markets. It’s an exciting time to be joining the team, especially with a new Regulatory Framework in the UK, and this position offers an excellent opportunity to be part of a motivated and collaborative team - optimising regulatory strategies to achieve product launch and supply and resolving product related issues as well as maintaining the highest standards of Regulatory Compliance and Quality.

Leadership Responsibilities

• Leadership of a team supporting a product portfolio including objective setting and coaching and development
• Delivery of regulatory strategy and activities for a portfolio of products across UK and Ireland enabling the delivery of business critical activities and maintaining the highest standards of regulatory compliance and quality.
• Member of Regulatory Leadership team, providing leadership in planning and coordination of Dept strategy, governance, driving & measuring performance and development and implementation of department procedures, KPIs and training
• Regulatory compliance and governance including risk management, process governance audit readiness activities and issue management in association with Head of Regulatory.
  

Functional Responsibilities

• Regulatory management of a product portfolio for Ireland and UK
• Primary interface with the regulatory authorities.
• Effective planning of regulatory activities for portfolio.
• Ensures compliant management of marketing authorisations and clinical trial applications.
• Ensure regulatory documentation are managed and maintained according to internal procedure.
• Ensure local responsibilities relating to regulatory conformance are adhered to, including MAH review of Periodic Quality Reviews.
• Takes a proactive lead and shows an ability to focus and identify key issues early and contribute fully to the development of solutions.
• Define and implement the annual UK & Ireland regulatory self inspection plan, in conjunction with UK/Ireland regulatory management team
• Provides considered regulatory advice, leadership and expertise to brand teams and to other regulatory and cross functional groups.
• Develop and maintain strong relationships with all key personnel within the MHRA and HPRA
• Builds and maintains effective relationships with key internal internal regulatory, commercial, supply chain and clinical groups including those at a senior level in Global Regulatory, Safety and Medical.
• Co-ordinates meetings with regulatory authorities and plays a key role in these interactions.
  

About You

Required Qualifications and experience:

• Degree in life sciences or equivalent
• Experience in the pharmaceutical industry
• Comprehensive understanding of regulatory requirements, policies, processes and environment (preferably Local (UK & Ireland) and European).
• Broad experience and comprehensive knowledge of drug development process, regulatory affairs, manufacturing and compliance - preferably with Local Operating Company Experience
• Capable of defining regulatory strategy or policy position.
• Capable of building and maintaining relationships with regulatory agencies
• Capable of running cross-functional teams and credibly representing GSK Local Company in external meetings with the regulatory agencies and other pharma companies.
• Proven ability to build, lead and motivate a small regulatory or matrix team.
• Good Interpersonal, communication and influencing skills
• Ability to work in a complex environment
• Capable of recruiting and leading staff
  

Closing Date for Applications: 11th July 2022 (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.

in R&D At GSK, we want to find new medicines and vaccines in ways that are faster, more effective and more predictable.

We start with what matters most, the science. Our approach to R&D focuses on science related to the immune system, the use of human genetics, and advanced technologies. Our pipeline currently comprises of more than 60 vaccines and medicines across four core therapeutic areas including oncology, infectious diseases, immunology / respiratory and HIV. We have pivotal study starts in 2021 for our RSV vaccine in older adults, COVID-19 assets, long-acting anti-IL-5 antagonist, daprodustat, and dostarlimab. In oncology, momentum is building with 15 potential medicines in trials, including nine immuno-oncology and three cell therapies.

We give our scientists the freedom to own the process. Our scientists often use genetic data to help us understand the root cause of disease. We steer the research where the data shows we can do most good. If a project doesn’t pan out, we take what we’ve learned and apply it elsewhere.

Technology can help us find patterns in genetic data better and faster. We’re using machine learning to unlock the potential of complex genetic data with new levels of speed, precision, and scale. And we’re one of the first biopharmaceutical companies to have created an in-house AI lab dedicated to drug development.

Even with the knowledge, tools, and resources within GSK, there’s always a benefit to new perspectives. That’s why we’re increasingly partnering with and hiring outstanding people from cutting edge fields like tech, data-science and academia. In 2018, GSK formed an exclusive, highly innovative collaboration with 23andMe, the world’s leading consumer genetics and research company. Other partners include: the Altius Institute; the UK Biobank, which is generating anonymized genetic sequence data from 500,000 volunteers; and the Open Targets Consortium, the mindset and approach of smaller, more agile startups.

Find out more: Our approach to R&D.

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we’re making the biggest 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.

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.

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 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.

Please don’t hesitate to contact us if you’d like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email ukdiversity.recruitment@gsk.com

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.

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