project manager Stevenage, England
Job description
Posted Date: Jul 14 2023
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.
In this role you will
- Manage, or be responsible for, the global CMC regulatory activities for multiple projects/teams simultaneously and respond readily to changing events and priorities.
- Be responsible for the strategy development and creation of CMC submission documents from early phase clinical submissions (IND/IMPD/CTA) through to marketing applications (BLA/MAA) and post approval activities.
- Understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new biopharmaceutical products, to expedite submission, review and approval of global CMC applications.
- Ensure that all appropriate CMC regulatory aspects for clinical trials/product release are in place, to avoid clinical holds and/or to ensure continuity of market supply. Also, ensure that information submitted in clinical/marketing applications meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.
- Work in cross-functional matrix project teams, which include colleagues from regulatory, biopharmaceutical development and manufacturing.
- 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.
- Engage in CMC Subject Matter Expert activities internally (for increased compliance, harmonisation and efficiency).
- Sometimes deliver CMC regulatory strategy to support major inspections (eg PAIs) with managerial support.
Closing Date for Applications: 30th July 2023 (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.
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Why you?
Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- Bachelors degree (or equivalent) within a relevant subject such as pharmacy, biotechnology, chemistry or a related scientific discipline, or demonstrable industry experience.
- Chemistry, Manufacturing and Controls (CMC) regulatory affairs or biopharmaceutical development experience gained with direct involvement in regulatory submission preparation across all stages of development, through to early life cycle submissions.
- Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.
- Proven ability to develop and implement regulatory strategies and evaluate the potential impact of them on overall project/product strategy.
- The ability to successfully influence and negotiate issues at a senior level within your organisation and with regulatory agencies in a variety of settings.
Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:
- Strong verbal and written communication skills with good attention to detail.
- Excellent team working abilities and effective influencing skills.
- Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.
- 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.
- Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.
- Experience of Agency interactions and/or submissions in US, EU, Japan and China.
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. 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 [email protected] or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels
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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