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Associate Director, CMC Regulatory Affairs

Collegeville, Pennsylvania; Rockville, Maryland; Waltham, Massachusetts
Closing date
Oct 29, 2021

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Other, Legal/Regulatory Affairs
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Site Name: USA - Pennsylvania - Upper Providence, USA - Maryland - Rockville, USA - Massachusetts - Waltham Posted Date: Jul 26 2021 Are you an experienced regulatory affairs professional with CMC experience looking to further your career? If so, this Associate Director, CMC Regulatory Affairs role could be an ideal opportunity to explore! We're seeking a highly motivated, self-driven and enthusiastic Regulatory Affairs professional to join our CMC Regulatory Affairs Group supporting the GSK Strategic External Development (SED) organization. At GSK, our CMC regulatory affairs group is responsible for a portfolio of biopharmaceutical products as well as small molecule products. This role requires you to interact across all the functions 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 an R&D site, however this role will interact across our global network. Reporting to the Director of CMC Regulatory Affairs, this position will plan and coordinate regulatory strategies necessary to support clinical development submissions, new registrations, and post approval submissions that meet global regulatory requirements and company business goals. The position will include projects in clinical development to study and commercialize important new COVID-19 therapies. 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 assigned projects 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 (IND/IMPD) through to marketing applications (BLA/MAA) and lifecycle management 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 biopharmaceutical products, to expedite the submission, review and approval of global CMC applications. o You will work in cross-functional matrix project teams, which include colleagues from regulatory, biopharmaceutical development, quality 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. The information that you have provided in your cover letter and CV will be used to assess your application. 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 biology, pharmacy, chemistry or a related scientific discipline, and at least 7 years of pharmaceutical company experience. You will also possess: o Three or more years Chemistry, Manufacturing and Controls (CMC) regulatory affairs or biopharmaceutical development experience with direct involvement in regulatory submission preparation across all stages of development. o Three or more years worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.o Preferred Qualifications: If you have the following characteristics, it would be a plus: o Excellent verbal and written communication skills o Detailed knowledge of the drug development and manufacturing and supply processes o Understanding of FDA regulations and ICH guidance pertaining to pharmaceutical development of NMEs and marketed products o Good time management skills with the ability to effectively plan, prioritise and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines. o Ability to work independently with minimal supervision as well as in a team environment o The ability to successfully influence and negotiate issues at the appropriate level within your organisation and/or with regulatory agencies in a variety of settings. o Strong problem-solving skills to evaluate technical information and identify appropriate regulatory strategies and actions. o Proven ability to develop and implement regulatory strategies and evaluate the potential impact of them on overall project/product strategy. o Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives. o Experience of Agency interactions and/or submissions in US, EU, Japan and China. o Resourceful, creative, enthusiastic, and results-oriented o Self-motivated, assertive, self-confident and acts with a sense of urgency and passion o Proven ability to work with a high level of integrity, accuracy, and attention to detail o Strong interpersonal skills 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 Support decision making using evidence and applying judgement to balance pace, rigour and risk. o Be committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. o Sustain energy and well-being, contributing to building resilience in teams. o Continuously look for opportunities to learn, build skills and share learning both internally and externally. o Translate strategy into action - a compelling narrative, setting objectives and motivating others. o Build 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. 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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