CMC Regulatory Project Manager
Site Name: USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Upper Providence Posted Date: Aug 19 2021 Are you a leader in CMC Regulatory Affairs in search of a role that will be responsible for CMC regulatory activities in the late phase development and/or commercial lifecycle management of GSK products? If so, this CMC Regulatory Project Manager role may be an ideal opportunity to explore! As a CMC Regulatory Project Manager, you will responsible for a portfolio of mature post approval 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 will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities. Responsible for CMC strategy development, with managerial support, for CMC submission documents to support marketed product lifecycle management activities in accordance with the applicable regulatory & scientific standards. Understands, interprets and will sometimes advise teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, review and approval of global CMC applications. Ensures all appropriate CMC regulatory aspects for product release are in place, to ensure continuity of market supply. Ensures information submitted lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions. Works in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy. Maintains high quality standards and seeks to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment. Ensures regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions. Engages in CMC Subject Matter Expert activities internally (for increased compliance, harmonisation and efficiency). Will sometimes deliver CMC regulatory strategy to support major inspections (eg PAIs) with managerial support. 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 Two or more years of Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience with direct involvement in regulatory submission preparation in late phase development and/or marketed product life cycle submissions. Two or more years experience in drug development, manufacturing processes and supply chain, and may have a specialized area of expertise. One or more years of experience working on worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for marketed products. Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced degree RAPS Certification Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Has broadened own knowledge base across regulatory functions to understand wider implications of emerging issues across projects. Experience in influencing and negotiating with company personnel and with regulatory agencies in a variety of settings. Strong interpersonal, presentation and communication skills with established internal networks. May be identified as CMC Regulatory expert in a specific subject area. Proactively seeks out and recommends process improvements Proven ability to develop and implement regulatory strategies and evaluate their potential impact on overall project/product strategy. Demonstrated ability to handle global CMC issues through continuous change and improvement Developing experience in major post approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management). 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. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. 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