GSK

Manager, Regulatory Affairs (non clinical regulatory)

Employer
GSK
Location
Collegeville, Pennsylvania
Salary
Competitive
Posted
August 19 2021
Ref
301825
Organization Type
Pharma
Job Type
Manager
Site Name: Belgium-Wavre, UK - Hertfordshire - Ware RD, USA - Pennsylvania - Upper Providence Posted Date: Aug 19 2021 Are you interested in a highly-visible US regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, Manager Regulatory Affairs (non clinical) could be an ideal opportunity to explore. As a Manager, Regulatory Affairs (non clinical), you will be responsible directing the nonclinical regulatory activities of multiple projects for Pharma and/or Vaccines. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Represents NCR on Regulatory Networks and Matrix Teams providing strategic direction and guidance to In Vitro/In Vivo Translation (IVIVT), Discovery Performance Units (DPU), Preclinical Development (PCD), preclinical groups in Vaccines Research Development Centers (RDCs), Clinical, Quality Assurance, 3rd Party Contract Management and Office of the Chief Medical Officer (OCMO) on both global project and key strategic business initiatives. May participate in discussions with Regulatory Authorities worldwide in all matters pertaining to nonclinical regulatory May have direct line management responsibility. May participate in corporate evaluation and provide nonclinical regulatory support/advice to in-licensing and divestment projects. Delivers nonclinical regulatory strategy to support audits or inspections. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree. Five or more years of experience in regulatory affairs. One or more years experience in managing teams and leading in a matrix organization. One or more years experience working with worldwide nonclinical regulatory requirements Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced degree in Pharmacy, Chemistry, Biology, Medicine, or similar discipline. RAPS regulatory certification Experience at a large global pharmaceutical or vaccines company Identified as Nonclinical Regulatory expert in a specific subject area. Experienced in supervising and training junior staff and has the ability to motivate and lead others. 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. Budgeting and forecasting, commercial and financial acumen. *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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