GSK

Director, Nonclinical Regulatory (NCR)

Employer
GSK
Location
Collegeville, Pennsylvania; Rockville, Maryland
Salary
Competitive
Posted
January 13 2021
Ref
276020
Organization Type
Pharma
Are you energized by facilitating and leading Nonclinical Regulatory strategy? If so, this Director, Nonclinical Regulatory (NCR) role could be an ideal opportunity to explore.

As the Director, Nonclinical Regulatory, you will be primarily responsible for driving strategic nonclinical regulatory activities for 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 and overseeing strategic direction and guidance to 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.
  • Lead and/or participate in discussions with Regulatory Authorities worldwide in all matters pertaining to Vaccines nonclinical regulatory.
  • Likely to 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.
  • Likely to be involved in and lead current, business critical activities across internal and external networks on behalf of GSK.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's degree specializing in life sciences, or equivalent
  • Experience and knowledge of drug development and may have a specialized are of expertise, specifically Vaccines experience.
  • Experience with complex worldwide nonclinical regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.
  • Project management experience and multi-tasking skills.
  • Experience in effective influencing and negotiating with regulatory agencies, industry bodies, and GSK personnel in a variety of settings.
  • Experience managing complex global nonclinical regulatory issues through continuous change and improvement.


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • M.Sc. or PhD, Life science or closely related science
  • Regulatory Affairs Certification (RAPS).
  • Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Has identified opportunities to further educate GSK colleagues and formulate GSK approaches to most effectively meet new requirements.
  • Identified as Nonclinical Regulatory expert in a Vaccines.
  • Proven experience in supervising and training staff within and across an organization.


Why GSK?

Our values and expectationsare 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.


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.

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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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