Manager or Associate Director CMC Regulatory Affairs (Small Molecule)
Site Name: USA - Pennsylvania - Upper Providence, USA - Massachusetts - Waltham Posted Date: Aug 26 2021 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 enabling them to Do More, Feel Better and Live Longer. This role can be based at our sites at Waltham, Massachusetts or Upper Providence, Pennsylvania, 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… o 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. o 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. o 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. o You will work in cross-functional matrix project teams, which include colleagues from regulatory, chemical and pharmaceutical development and manufacturing. o 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. Interested in joining the team? When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you provide in your cover letter and CV will be used to assess your application. Closing date for applications: 30 Sept 2021. 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. Thank you for your interest in this opportunity. Why you? Basic Qualifications: In this role you will require a bachelor degree (or equivalent) within a relevant subject such as pharmacy, chemistry or a related scientific discipline. You will also possess: o 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. o Four or more years experience in worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development. o Two or more years of experience roven ability to develop and implement complex regulatory strategies and evaluate the potential impact of them on overall project/product strategy. o Successfully influenced and negotiated issues at a senior level within your organisation and with regulatory agencies in a variety of settings. o Proven ability to manage and direct multiple projects/teams simuletaneously with excellent team working abilities and adjust to changing priorities. Preferred Qualifications: If you have the following characteristics, it would be a plus: o Experience of recent regulatory submissions for injectable products .o Small Molecule experience o Strong verbal and written communication skills with good attention to detail. o Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives. o Experience in corporate evaluation and provision of CMC regulatory advice to in-licensing and divestment projects. o Experience of being involved in/leading business critical initiatives within and external to the organisation. Why GSK? 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: o Supporting decision making using evidence and applying judgement to balance pace, rigour and risk. o Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. o Sustaining energy and well-being, contributing to building resilience in teams. o Continuously looking for opportunities to learn, build skills and share learning both internally and externally. o Translating strategy into action - a compelling narrative, setting objectives and motivating others. o Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. *This*LI-GSK is a job description to aide in the job posting, but does not include all job evaluation details. 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