Regulatory Affairs Manager - Strategic Labelling and Development
Job Description – Manager, Strategic Labelling & Development
Are you an enthusiastic regulatory professional with experience or an interest in developing patient and prescriber information while pursuing a career in a global pharmaceutical company? If so, GSK currently has opportunities in its Global Regulatory Affairs (GRA)- Labelling department, within research and development, and this Labelling role may be an ideal opportunity for you to explore.
At GSK, we’re constantly developing new products and maintaining our established medicines to improve the quality of human life. Ensuring these products are correctly prescribed and used is essential, and that’s where our labelling team is key. The Labelling team supports our portfolio of medicines by ensuring that the information relating to the safety and efficacy of our products reaches patients and prescribers. This is done through the creation and management of our Company Core Data Sheet, which contains information for prescribers and patients. As a Labelling Manager in the UK-based team, you will help us support our exciting pipeline of new products. As a global position, you will be providing labelling support to colleagues in markets worldwide. This may include work on the US PI; European SmPC, patient information leaflet and label; and prescribing/patient information for other major international markets, including Asia Pacific and key emerging markets.
Our labelling development team supports a product during development and throughout its early lifecycle, and we are the authors of Global Datasheets for GSK products. You will liaise with colleagues in clinical, safety and other regulatory functions to ensure that the Prescribing Information, Patient Leaflets and Packaging Components accurately reflect the Company's medical and scientific position regarding the safe and effective use of a GSK product.
In this role you will
- Lead the development of the Global Datasheet for new medicines or product line extensions.
- Manage core and local prescribing/patient information through development and for newly approved products.
- Work with colleagues in markets worldwide to ensure implementation of the global datasheet into local prescribing/patient information.
- Author responses to regulatory questions on prescribing/patient information from Regulatory Authorities.
- Author documentation to support Labelling Governance Committees.
- Interface with key labelling and governance stakeholders across GSK.
- Manage documentation to support global and country/regional product information (PI) development and early maintenance.
- Author and manage US PI for products registered in the US.
- Author and manage EU PI annexes for products registered via the EU centralised procedure.
- Management of GRA Labelling data in appropriate systems and databases (primarily Veeva vault).
- Mentor colleagues on Labelling processes
- Serve as back-up for manager at Governance meetings
- Represent GSK at external conferences
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- BSc in Pharmacy or Life Sciences related subject
- Proven leadership skills in a matrix environment
- Relevant Labelling experience such as pharmacy, regulatory affairs, medical affairs, clinical research, pharmacovigilance, or therapeutic area experience.
- An understanding of company priorities and responds appropriately with flexibility to ensure deadlines are met successfully.
- Specific experience with prescribing/patient information.
- Track record of authoring clear scientific labelling text for health professionals and patients
- Experience in managing senior stakeholders to meet internal and external deadlines
Preferred Qualifications & Skills:
Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:
- Ability to recognise and resolve conflicts
- Ability to work in complex matrix teams
- Demonstrated high attention to detail and accuracy.
- Excellent communication skills
- Shows a focus on improving performance and excellence in all tasks.
- Challenges ways of working to seek improved process.
- Ability to make sound decisions.
- Proactively seek information, guidance and insight from a broad range of sources and weigh benefits and risks before making important decisions.
Closing Date for Applications – 18th February 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.
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.firstname.lastname@example.org 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
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.
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.
We’re moving towards a more sustainable future with our new headquarters. With better public transport links and proximity to world-class science and technology institutions, we’re excited for our move to the vicinity of Earnshaw Street, London WC1A (“the New HQ”) by end H1 2024.