Director, Nonclinical Regulatory (NCR
Company: GSK Poland
Posted on: February 22, 2021
- Collegeville, Pennsylvania; Wavre, Belgium; Ware, United
Kingdom; Rockville, Maryland
- 276020 Job description Site Name: Belgium-Wavre, UK -
Hertfordshire - Ware, USA - Maryland - Rockville, USA -
Pennsylvania - Upper Providence
Posted Date: Jan 13 2021
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
- Likely to have direct line management responsibility.
- May participate in corporate evaluation and provide nonclinical
regulatory support/advice to in-licensing and divestment
- Delivers nonclinical regulatory strategy to support audits or
- 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
- Experience and knowledge of drug development and may have a
specialized are of expertise, specifically Vaccines
- 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
- 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 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
- 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.Important notice to Employment businesses/ AgenciesGSK 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
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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
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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
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Keywords: GSK Poland, Rockville , Director, Nonclinical Regulatory (NCR, Executive , Rockville, Maryland
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