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Regulatory Project Manager

Employer
GSK
Location
Collegeville, Pennsylvania
Salary
Competitive
Closing date
May 22, 2022

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Discipline
Other, Legal/Regulatory Affairs
Job Type
Project Manager
Organization Type
Pharma
Site Name: USA - Pennsylvania - Upper Providence, UK - London - Brentford Posted Date: Apr 28 2022 Are you looking to lead CMC regulatory activities in the post approval space for Biopharm products? As a Regulatory Project Manager, you Will be responsible for the CMC regulatory activities in the late phase development and/or commercial lifecycle management of GSK products. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Lead the regulatory process redesign using lean and six sigma methodologies with cross-functional teams resulting in improved process efficiency and quality. Work directly with customers to establish goals and objectives related to lean, process design, including quality targets. Work with subject matter experts to map current and future processes, seek efficiencies, and integrate written standards and training requirements. Prioritize projects to ensure internal resources are appropriately applied to achieve established goals. Establish and monitor metrics relative to process redesigns and implementation. Conduct periodic progress reviews and update senior leadership on the changes and planned deployment. Audit closed projects to ensure results are maintained. 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: B.Sc. in Life Sciences or related scientific disciplines - To ensure a good understanding of the science behind physical product manufacture, and the associated regulatory challenges with maintaining a compliant supply chain. 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. Sound knowledge of drug development, manufacturing processes and supply chain and may have a specialized area of expertise. Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for marketed products. 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. Preferred Qualifications: Masters degree in Life Sciences or related scientific disciplines 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? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. *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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