GSK

Manager or Associate Director CMC Regulatory Affairs (Small Molecule)

Employer
GSK
Location
Waltham, Massachusetts; Collegeville, Pennsylvania
Salary
Competitive
Posted
October 14 2021
Ref
302878
Organization Type
Pharma
Site Name: USA - Massachusetts - Waltham, UK - Hertfordshire - Ware RD, USA - Pennsylvania - Upper Providence Posted Date: Oct 14 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. 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* is a job description to aide in the job posting, but does not include all job evaluation details. *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. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. 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. 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.

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