Nonclinical Regulatory Project Manager, Open to flexible working

Location
Ware, Hertfordshire
Salary
£Competitive
Posted
23 Apr 2021
Closes
23 May 2021
Ref
287544
Contract Type
Permanent

Responsible for the nonclinical regulatory activities of multiple projects for Pharma and/or Vaccines.

Key Responsibilities

  • Represents NCR on Regulatory Networks and Matrix Teams providing regulatory advice and guidance to In Vitro/In Vivo Translation (IVIVT), Reseach Units (RUs), 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) to produce appropriate nonclinical components for global regulatory dossiers with appropriate guidance from supervisor, as necessary.
  • May coach or train staff.
  • May participate in corporate evaluation and provide nonclinical regulatory support/advice to in-licensing and divestment projects.
  • May deliver nonclinical regulatory strategy to support audits.
  • Understands and advises on regulations, guidelines, procedures and policies relating to development, registration and lifecycle management of pharmaceutical and/or vaccine products, to expedite submission, review and approval of global regulatory applications.
  • Thereby, with management oversight, as necessary, ensuring all appropriate nonclinical regulatory aspects for clinical trials are in place, to avoid clinical holds. Ensuring information submitted in marketing applications meets regional requirements, allowing maximum flexibility with minimal unanticipated questions.
  • Ensure all appropriate nonclinical regulatory aspects to support license maintenance are delivered to agreed timelines.
  • Manages multiple projects and teams simultaneously and provides data assessment and conclusions within and across departments.
  • Formulates alternative approaches and influences people, systems and processes.
  • Independently identifies risks associated with submission data and information packages.
  • Contributes to, and leads (as required), the creation, maintenance and continuous improvement of nonclinical regulatory processes, policies and systems.
  • Leads and motivates staff within and across departments on assigned tasks.
  • May contribute to efforts to influence the internal/external Nonclinical Regulatory environment.
  • Has established organisational networks.
  • Communicates across GSK as necessary, to influence nonclinical project and policy issues that are aligned with GSK business needs ensuring optimum position for GSK.
  • Able to demonstrate the following key high performance behaviours, customer driven, flexible thinking, and continuous improvement.
  • May operate with independence, recognizes matters that affect corporate or agency policies and makes management aware of any nonclinical issues with high business impact.
  • Commercially astute and able to deal with sensitive and confidential issues.

Basic Qualifications

  • Bachelors degree, Life science or closely related science.
  • Sound knowledge of drug development processes.
  • Detailed knowledge of worldwide nonclinical regulatory requirements.
  • Successfully managed multiple projects/teams simultaneously

Preferred Qualifications

  • Higher degree, 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 broadened own knowledge base across regulatory functions to understand wider implications of emerging issues across projects.
  • Experience in influencing and negotiating with GSK personnel in a variety of settings.
  • Highly developed interpersonal, presentation and communication skills with established internal and external networks.

Company Details:

At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best.

When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it's about you being motivated to do your best work, in a place where you can be you, feel good and keep growing.

Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers.

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Important notice to Employment businesses/ Agencies

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