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CMC Global Regulatory Affairs Director, Small Molecule New


CMC Global Regulatory Affairs Director, Small Molecule New

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Industry sector

Pharmaceutical Industry

Job type

Permanent | Full Time


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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 will be based at our site 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 direct key, strategic global CMC regulatory activities from early phase clinical submissions through to marketing applications and early lifecycle activities and respond readily to changing events and priorities.You will 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 communicate strategic direction, data assessment and risk mitigation strategies to senior management.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. You are likely to have direct line management responsibility.Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Bachelor’s degree or equivalent within a relevant subject such as pharmacy, chemistry or a related scientific discipline.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.Global CMC regulatory submission experience including delivering dossiers that comply with theseNew Molecular Entity or New Chemical Entity small molecule experience Preferred Qualifications:If you have the following characteristics, it would be a plus:Highly motivated with experience of direct line management and proven ability to manage and direct multiple projects/matrix teams.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 recent regulatory submissions for injectable products.Experience of Agency interactions / submissions in China.Experience of being involved in/leading business critical initiatives within and external to the organisation.Ability to develop and implement complex regulatory strategies and evaluate the potential impact of them on overall project/product strategy.Proven track record of successfully influencing and negotiating issues at a senior level within your organisation and with regulatory agencies in a variety of settings.Proven track record of managing and directing multiple projects/teams simultaneously with excellent team working abilities and adjust to changing priorities.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: Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk.Managing individual and team performance.Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.Implementing change initiatives and leading change.Sustaining energy and well-being, building resilience in teams.Continuously looking for opportunities to learn, build skills and share learning both internally and externally.Developing people and building a talent pipeline.Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.*LI-GSKIf 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/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.Full time

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Ware, Ware, England, Hertfordshire, SG12, United Kingdom

  • Ad ID:  14900978
  • Ad Type:  Offered
  • Posted on:  04/07/2020, 02:53
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