CMC Regulatory Manager, Open to flexible working
1 day left
- Contract Type
We're seeking a highly motivated, self-driven and enthusiastic Regulatory Affairs professional to join our CMC Regulatory Affairs Group. At GSK, our Mature Products CMC regulatory affairs group is responsible for a portfolio of small molecule products. This role requires you to interact across different functions at GSK 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.
This role can be based at our sites at GSK House, UK, RTP, USA, or Upper Providence, USA, however this role will interact across our global network.
This role will provide you the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
- 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.
- You will be responsible for the strategy development and creation of CMC submission documents to support lifecycle activities.
- Deliver CMC Regulatory Strategy to support major inspections or quality incidents
- You will need to understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to lifecycle changes and variations in relation to the manufacture of pharmaceutical products, to expedite submission, review and approval of global CMC applications.
- You will work in cross-functional matrix project teams, which include colleagues from regulatory, quality and manufacturing (compliance and technical).
- You will 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.
- BSc in Pharmacy, Chemistry or related scientific discipline or equivalent qualification
- Detailed knowledge of drug development and/or manufacturing and supply processes
- CMC authoring experience
- 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
- Excellent team working abilities and effective influencing skills
- 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 and
- Commercially astute and politically sensitive and able to manage sensitive and confidential issues
If you have the following characteristics, it would be a plus:
- Experience of evaluation and provision of CMC regulatory advice to in-licensing and divestment projects
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Supporting decision making using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Sustaining energy and well-being, contributing to building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Translating strategy into action - a compelling narrative, setting objectives and motivating others.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
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.
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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