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Manager or Associate Director, CMC Regulatory Affairs

Collegeville, Pennsylvania; Waltham, Massachusetts
Closing date
Jul 28, 2021

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Site Name: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: Jul 20 2021 Are you a professional with CMC Regulatory Affairs experience looking to expand and grow in your career? We're seeking a highly motivated, self-driven and enthusiastic Regulatory Affairs professional to join our Biopharm CMC Regulatory Affairs Group. At GSK, our Biopharm CMC regulatory affairs group is responsible for a portfolio of biopharmaceuticals and Cell & Gene Therapy 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. If this sounds exciting, this Manager, CMC RA could be an ideal role to pursue. As a Manager, Biopharm CMC Regulatory Affairs, you will direct the CMC regulatory activities of multiple projects and dosage forms. As an example of current projects in the team include working on marketing authorisations for Oncology and COVID-19 products. 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… Manage the global CMC regulatory activities for multiple projects/teams simultaneously and respond readily to changing events and priorities. Strategy development and creation of CMC submission documents from early phase clinical submissions through to marketing applications and lifecycle activities. 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. Represent Global CMC Regulatory, on Regulatory Networks and Matrix Teams providing strategic direction and guidance to Preclinical Development (PCD), Biopharm, Pharma Supply Chain (PSC), Clinical Supplies, Commercial, Quality Assurance, 3rd Party Contract Management and Global Regulatory and Quality (GRQ) on both global project and key strategic business initiatives. 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: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in biotechnology, chemistry, pharmacy or closely related science Experience with drug development and manufacturing and supply processes. Experience and working knowledge of worldwide CMC regulatory requirements. Experience managing and directing multiple projects/teams. Preferred Qualifications: If you have the following characteristics, it would be a plus: Successfully influenced and negotiated issues with regulatory agencies and GSK personnel in a variety of settings. Experienced in supervising and training junior staff and the ability to motivate and lead others. Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives. Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Demonstrated ability to handle complex global CMC issues through continuous change and improvement Biologics experience CMC Marketing experience 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. 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. If this role is not for you, we are sure that you know great talent and so we ask that you please share this vacancy with your external network. If you successfully refer someone to GSK you may be eligible to receive a cash bonus as a reward. To do this please click the “Refer” button to share with specific individuals who you think would be a great fit, or the “Share” button to publish to your social networks. Thank you! 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, rigor 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. 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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