CMC Regulatory Affairs Manager - Brentford, United Kingdom - GlaxoSmithKline

Description

Site Name: UK - London - Brentford, USA - North Carolina - Durham
Posted Date: May 9 2024
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.

As a CMC Regulatory Affairs Manager, you will be a member of the CMC Small Molecules, Mature Products management team. In this role you will direct project activities for multiple complex projects, providing strategic direction, data assessment and conclusions within and across departments. You will be an important part of the team responsible for lifecycle maintenance and network strategy activities for GSK's small molecules portfolio.

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

Y our Responsibilities:

This role will provide you the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.

• You will be accountable for the global CMC regulatory activities for multiple projects simultaneously and respond readily to changing events and priorities,
• You will be responsible for the strategy development and CMC project oversight to support uninterrupted supply of medicines through compliant Marketing Authorisations,
• You will deliver CMC regulatory strategy to support major inspections and quality incidents.
• You will represent Global CMC Regulatory in key strategic business initiatives/global projects,
• You will have dossier Approver responsibilities,
• You will work in cross-functional matrix project teams, which include colleagues from the wider regulatory organisation, quality and manufacturing. You will direct and communicate complex regulatory issues independently across GSK and with third parties, as necessary, to influence CMC project and policy issues that are aligned with GSK business needs ensuring optimum position for GSK.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals,

• BSc in Pharmacy, Chemistry or related scientific discipline or equivalent qualification
• Experience in authoring CMC dossier components,
• Detailed knowledge of drug development and/or manufacturing and supply processes,
• Detailed working knowledge of worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment,
• Successful track record of managing multiple projects/teams simultaneously,
• Experience of evaluation and provision of CMC regulatory advice to in-licensing and divestment projects.

Preferred Qualifications:

If you have the following characteristics, it would be a plus,

• Good time management skills with the ability to effectively plan, prioritise and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines,
• Demonstrated ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives,
• Demonstrated ability to lead cross-department initiatives with effective influencing skills,
• Commercially astute and politically sensitive and able to manage sensitive and confidential issues,

Closing Date for Applications - 23rd May 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:

Our approach to R&D .

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

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.