The Global Regulatory Affairs Project Director works directly with Global Regulatory Affairs (GRA), Product Development, and Market Access Leadership, GRA personnel, as well as nonclinical and clinical operations, and Finance in managing complex projects and leading the regulatory project management team.
This includes the project review process, raising issues for resolution, ensuring action items are completed, and communicating the health of both project and the portfolio to GRA Leadership.
Candidate will work with key leaders to manage the overall performance of the portfolio by interpreting metric and project review information resulting in actionable plans to improve delivery efficiencies to our clients.
Candidate will assume responsibility for GRA business development activities intended to increase business for regulatory services.
Additional responsibilities include leading cross-project and financial processes improvements, mentoring teams on improving project performance and taking on special projects as deemed appropriate by GRA Leadership.
What to Expect
Lead a team of Regulatory Project Managers providing a range of regulatory services to clients, both as standalone regulatory projects and as components of a broader engagement such as a clinical study.
Manage larger or more complex regulatory projects, providing training and mentoring opportunities for staff.
Manage project management metrics, project tracking, resource requirements, contracting, and revenue tracking
Identify, promote and implement best practices for regulatory affairs driving for sustainable competitive advantage
Assist with the development of proposals, including the development of proposal templates and associated costing tools
Assist with the identification and selection of, and alignment and operations with partners
Perform other duties as assigned by business unit leadership.
Education / Qualifications
University / college degree (life science preferred), business, project management or certification in a related allied health profession ( nursing, medical or laboratory technology) from an appropriately accredited institution.
Knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
A good understanding of the drug development process.
At least 10 years experience in the pharmaceutical industry with 7 years preferably in Regulatory Affairs or in Drug Development.
Demonstrated skills and competency in project management tasks
Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
Broad knowledge of drug development process and client needs.
Comprehensive understanding of processes associated with Global Regulatory Affairs activities
Skilled in trouble-shooting and issue resolution
Strong interpretation and analytical skills within and across projects / portfolios leading to documented efficiency improvements
Ability to lead diverse cross-functional teams and deliver measurable results
Experience in managing a project budget with documented cost containment strategies.
Ability to work with minimal supervision.
Excellent communication, facilitation and presentation skills
Good conflict management skills
Good computer skills with a working knowledge of a range of computer applications.
Excellent planning, time management and organization skills.
Ability to work efficiently and effectively in a matrix environment.
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