RockvilleMDRecruiter Since 2001
the smart solution for Rockville jobs

Director, Nonclinical Regulatory (NCR

Company: GSK Poland
Location: Rockville
Posted on: February 22, 2021

Job Description:

  • Collegeville, Pennsylvania; Wavre, Belgium; Ware, United Kingdom; Rockville, Maryland
  • Regulatory
  • 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 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 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.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 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. This is our global website, intended for visitors seeking information on GSK's worldwide business. Our market sites can be reached by visiting our market selector .

Keywords: GSK Poland, Rockville , Director, Nonclinical Regulatory (NCR, Executive , Rockville, Maryland

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Management Analyst I
Description: Job AnnouncementWorks as a part of the Northern Virginia Regional Projects Office NVRPO to provide entry-level professional analytic and technical support for the Commonwealth of Virginia's, Department (more...)
Company: Fairfax County Government
Location: Annandale
Posted on: 03/5/2021

OB Women and Children Nursing Manager
Description: Seeking a Manager of Nursing Operations to oversee the Obstetrics department in a Critical Access Hospital Also affiliated with several other hospitals/outpatient sites in the area Within this health (more...)
Company: KA Recruiting, Inc.
Location: Leesburg
Posted on: 03/5/2021

Salon Manager - Chelsea Square
Description: Salon ManagerGot shears and a winning attitude Have a yearning to earn and a desire to hire and support other stylists Then let's talk Maybe you're a stylist who wants more responsibility,
Company: Great Clips
Location: Lancaster
Posted on: 03/5/2021


Capture Manager - Security Detection and Automation
Description: Description Job Description: Capture Manager - Business Development Strategy BD S , Capture Operations Excellence CO E , Security Detection Automation SD A Civil Job Description The Security (more...)
Company: Leidos
Location: Reston
Posted on: 03/5/2021

Senior Vice President, Cyber Risk
Description: Our professionals balance analytical skills, deep market insight and independence to deliver solid, defensible analysis and practical advice to our clients. As an organization, we value the diverse backgrounds (more...)
Company: Kroll
Location: Sterling
Posted on: 03/5/2021

On-Your-Lot Territory Manager
Description: Keystone Custom Homes is looking for a dynamic On Your Lot Territory Manager to join our innovative and agile team on our journey to unprecedented levels of success.
Company: Keystone Custom Homes
Location: Lancaster
Posted on: 03/5/2021

Director of Construction
Description: Comstock Holding Companies, Inc. Nasdaq: CHCI is a leading real estate development, asset management and real estate services company that has designed, developed, constructed and managed several thousand (more...)
Company: Comstock Companies
Location: Reston
Posted on: 03/5/2021

Solar Sales Manager
Description: Momentum Solar is a premier residential solar provider with offices throughout the U.S. Founded in 2009, Momentum has grown exponentially over the past decade. We implement the entire solar process to (more...)
Company: Momentum Solar
Location: Lancaster
Posted on: 03/5/2021

ServiceNow Platform Engineering Manager
Description: Job ID: br 213197 br Location: br RESTON br , br VA br , br US br Date Posted: 2021-03-02Category: Engineering and SciencesSubcategory: Solutions ArchtSchedule: Full-timeShift: Day JobTravel: (more...)
Company: SAIC
Location: Reston
Posted on: 03/5/2021

Configuration Manager
Description: Job Responsibilities Develop, execute, and manage configuration CRQs and apply and update baseline documentation for all devices on network utilizing adopted FERC government standards/security best practices. (more...)
Company: Dunhill Professional Search
Location: Chantilly
Posted on: 03/5/2021

Log In or Create An Account

Get the latest Maryland jobs by following @recnetMD on Twitter!

Rockville RSS job feeds