AddressPosted Date: Mar 13 2024
We’re seeking a highly motivated, self-driven and enthusiastic Regulatory Affairs professional to join our Biopharm CMC Regulatory Affairs Group. At GSK, our Biopharm CMC Regulatory Affairs group is responsible for a portfolio of biopharmaceuticals products. This role requires you to interact across all the functions of Global Regulatory Affairs to ensure global approaches and strong connectivity. You will play a key part in GSK’s commitment to making a difference to patients’ lives enabling them to Do More, Feel Better and Live Longer.
As a Manager, Biopharm CMC Regulatory Affairs, you will direct the CMC regulatory activities of multiple projects and dosage forms
This role can be based at our sites at Ware, Hertfordshire, UK, GSK House, London, UK, Waltham, Massachusetts, USA or at Upper Providence, Pennsylvania, USA, however this role will interact across our global network.
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 webpage Life at GSK | GSK
In this role you will
- Manage the global CMC regulatory activities for multiple projects/teams simultaneously and respond readily to changing events and priorities.
- Be involved with strategy development and creation of CMC submission documents from early phase clinical submissions through to marketing applications and lifecycle activities.
- Understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new pharmaceutical products, to expedite submission, review and approval of global CMC applications.
- Represent Global CMC Regulatory, on Regulatory Networks and Matrix Teams providing strategic direction and guidance to Preclinical Development (PCD), Biopharm, Global Supply Chain (GSC), Clinical Supplies, Commercial, Quality Assurance, 3rd Party Contract Management and Global Regulatory and Quality (GRQ) on both global project and key strategic business initiatives.
- Maintain high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree in biotechnology, chemistry, pharmacy or closely related science
- Detailed knowledge of drug development and manufacturing and supply processes.
- Detailed working knowledge of worldwide CMC regulatory requirements.
- High ability to manage and direct multiple projects/teams.
- Demonstrated ability to handle complex global CMC issues through continuous change and improvement
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Demonstrated ability to manage late phase CMC clinical trial activities
- Successfully influenced and negotiated issues with regulatory agencies and GSK personnel in a variety of settings.
- Experienced in supervising and training junior staff and the ability to motivate and lead others.
- Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.
- Continued professional growth in global Regulatory Affairs including communication of evolving/emerging trends and policies.
Closing Date for Applications – 27th March 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.
Why Us?
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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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 Ukdiversity.recruitment@gsk.com 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 link and scroll to the Careers Section where you will find answers to multiple questions we receive
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