CMC Regulatory Project Manager (Biologics and Vaccines)
Site Name: UK - Hertfordshire - Ware, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: Mar 23 2021 Are you a leader in CMC Regulatory Affairs in search of a role that will enable you to interact across all the functions of Global Regulatory Affairs, while ensuring global approaches and strong connectivity? If so, we are seeking a highly motivated, self-driven and enthusiastic Regulatory Affairs professional to join our Biopharm CMC Regulatory Affairs Group and this could be an ideal opportunity to explore. As a CMC Regulatory Project Manager, you will responsible for a portfolio of biopharmaceuticals and Cell & Gene Therapy products. 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 Ware, Hertfordshire or at Upper Providence, Pennsylvania, 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 from early phase clinical submissions through to marketing applications and post approval activities. You will need to 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. You will work in cross-functional matrix project teams, which include colleagues from regulatory, biopharmaceutical 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. 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. 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. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: In this role you will require a bachelor's degree (or equivalent) within a relevant subject such as pharmacy, biotechnology, chemistry or a related scientific discipline Chemistry, Manufacturing and Controls (CMC) regulatory affairs or biopharmaceutical development experience gained with direct involvement in regulatory submission preparation across all stages of development. Preferred Qualifications: If you have the following characteristics, it would be a plus: Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development Good time management skills with the ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines. The ability to successfully influence and negotiate issues at a senior level within your organization and/or with regulatory agencies in a variety of settings. 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. Proven ability to develop and implement regulatory strategies and evaluate the potential impact of them on overall project/product strategy. 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. 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: Operating at pace and agile 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. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. 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