Nonclinical Regulatory Project Manager, Open to flexible working
Responsible for the nonclinical regulatory activities of multiple projects for Pharma and/or Vaccines.
- 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.
- 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
- 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.
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