Associate Director, Global Regulatory Affairs - Speciality Therapeutic Group - Flexible working
Are you a Regulatory Affairs expert looking for an exciting opportunity to develop your career and advance your personal development journey within an innovative, collaborative, inclusive and diverse Research and Development organisation? If so, then this role could be for you!
We have a fantastic opportunity for a talented Associate Director with strong global regulatory affairs knowledge/experience and interpersonal skills to join our GSK Speciality Therapeutic Group, Global Regulatory Affairs team in West London, UK
We are open to remote working for this role with some travel to GSK House preferred.
As a valued member of the Regulatory Matrix team(s) and the asset project team(s), you will be empowered to develop appropriate global regulatory strategy(s) and ensure their execution for assigned asset(s), consistent with the Medicines Development Strategy. With your innovative approach, strong regulatory expertise and communication/negotiation skills, you will provide global regulatory strategic leadership and support for assigned asset(s) in the Pharmaceutical R&D portfolio and life cycle management.
This role will be accountable to the Global Regulatory Lead and Global Regulatory Therapeutic Area Head for the development of appropriate global regulatory strategy(s) and for delivery according to plans. In conducting this role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with regulatory agencies.
‘Be You’ at GSK
At GSK, we're a company with a purpose to help people do more, feel better and live longer. We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process.
We will be delighted to hear from talented individuals that align to our values. These are at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.
When you set out on your adventure at GSK, we make a deal. You commit to living our values and expectations and performing against our Innovation, Performance and Trust priorities. In return, GSK commits to providing the right environment for you to thrive. Together, we build an environment where we can all thrive and focus on what matters most to each of us.
As a modern employer, we empower you to be yourself, share ideas and work collaboratively.
In this role you will
- Work with the Medicine Development Team (MDT), LOC teams and GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile.
- Work closely with the central/local / regional commercial teams to secure best possible labeling commensurate with the available data. Lead interactions with local / regional regulatory authorities.
- Proactively develop innovative global regulatory strategy(s) for allocated asset that will deliver the global needs taking in to account the needs of key regions Implementation of the strategy(s) in support of the project globally.
- Lead preparations and delivery of health authority interactions with the cross functional central team and the development and regulatory teams in the local regions.
- Prepare and/or co-ordinate regulatory documentation to support early phase development which may include briefing documents, orphan drug applications, clinical trial applications, amendments, and paediatric investigation plans. Ensuring appropriate interactions with global/regional counterparts and commercial teams in local region in these activities.
- Ensure compliance with global/ regional requirements at all stages of product life from Commit to Medicine Development to Life Cycle Management.
- 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.
Closing Date for Applications: 12th June 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.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
Qualifications & Skills:
- Bachelor’s degree or preferably PhD in biological or healthcare science
- Knowledge and experience in all phases of the drug development process and life cycle management in regulatory affairs preferred including developing and implementing regulatory strategy
- Ability to integrate regulatory science with scientific/clinical knowledge. Capable of leading global development, submission and approval activities including regulatory interactions and negotiations
- Extensive knowledge of clinical trial and licensing requirements in all major countries including US, EU, China, Japan and Emerging Markets and ideally knowledge of other key Agency processes in these regions
- Knowledge of relevant therapy area, experience with biologics, and ability to further develop necessary specialist knowledge for the asset or area of medicine
In addition to your regulatory expertise, the successful candidate will demonstrate competencies of strategic thinking, strategic influencing, innovation, initiative and leadership.
- Being ambitious for patients, accountable for impact and doing the right thing always.
- Innovative mindset; challenges the status quo.
- Strong oral and written communication skills. Capable of delivering key communications with clarity, impact and passion, tailored to the audience.
- Excellent planning, organisational and time management skills with the ability to work simultaneously on multiple projects.
- Ideally good listening and comprehension skills; proactive in identifying potential issues and escalating them accordingly.
- Ability to foster strong matrix working. Involve people in issues that affect them. Facilitate dialogue between team and matrix members so they understand links between their different ideas and perspectives. Capable of developing and recommending strategies for change. Developing personal networks within GSK and capable of using them to secure appropriate support and outcome for a project.
- Capable of identifying project or team issues in advance and seeking necessary help and support to resolve.
- Ability to derive innovative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions.
- Recognise potential long-term issues for projects.
- 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. Show a constant focus on improving performance and excellence in all tasks. Challenge and question ways of working to seek improved process. Seek to raise levels of performance by establishing or improving process
- Develop personal networks, within GSK and capable of using them to secure appropriate support and outcome for a project.
- Highly motivated and able to work independently with limited supervision.
GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. This special purpose – along with our goal of being one of the world’s most innovative, best performing and trusted healthcare companies – helps us attract some of the best and brightest minds in the world.
We take pride in providing access to all and continually focus on our opportunity and obligation to do more to improve inclusion and diversity: for our people inside GSK; in the way we do business; and in the communities where we operate.
We want our company to be a place where diversity of people and thought is valued everywhere and where we’re all able to be ourselves and feel a sense of belonging. An inclusive organization where we all feel valued, engaged and supported, knowing that our work makes an important contribution to our mission. Reinforced by our clear values and expectations, it is part of our DNA. Together we achieve extraordinary things for our patients and consumers, who rely on us each and every day.
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.
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