We're seeking a highly motivated, self-driven and enthusiastic Regulatory Affairs professional to join our CMC Regulatory Affairs Group. At GSK, our Development Projects CMC regulatory affairs group is responsible for a portfolio of new small molecule and oligonucleotide 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.
This role can be based at our sites at USA - Upper Providence, Pennsylvania, or UK - Hertfordshire - Ware, 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:
Why you? Basic Qualifications:
- 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 from early phase clinical submissions through to marketing applications and early lifecycle activities.
- You will need to 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.
- You will work in cross-functional matrix project teams, which include colleagues from regulatory, chemical and pharmaceutical development and manufacturing.
- 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.
In this role you will require a bachelor's degree (or equivalent) within a relevant subject such as pharmacy, chemistry, or a related scientific discipline.
You will also possess:
- Chemistry, Manufacturing and Controls (CMC) regulatory affairs or chemical and pharmaceutical development experience gained with direct involvement in regulatory submission preparation across all stages of development, through to early life cycle submissions.
- Four or more years of experience in worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.
- Two or more years of experience, proven ability to develop and implement complex regulatory strategies and evaluate the potential impact of them on overall project/product strategy.
- Experience with development and regulatory CMC aspects of Small Molecules.
- Experience of recent regulatory submissions for injectable products.
- Experience in managing and directing multiple projects/teams simultaneously.
If you have the following characteristics, it would be a plus:
- Successfully influenced and negotiated issues at a senior level within your organization and with regulatory agencies in a variety of settings.
- Strong verbal and written communication skills with good attention to detail.
- Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.
- Experience in corporate evaluation and provision of CMC regulatory advice to in-licensing and divestment projects.
- Experience of being involved in/leading business critical initiatives within and external to the organization.
Our values and expectationsare 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, rigor, 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.
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