VP, Regulatory Science
Provide strategic leadership to ensure the scientific credibility of the Company. Ensures the development and execution of scientific and regulatory strategies which enable the Company to meet all global regulatory requirements. Serves as the Company representative on scientific issues of product safety, risk assessment, and governmental regulatory activities
ESSENTIAL JOB ACCOUNTABILITIES
* Develop vision, strategies and tactics for Research advises management with respect to recommended strategies, tactics and positions on scientific and technical issues and communicates strategies to non-technical colleagues in the Company.
* Develops and maintains product stewardship guidelines and sets strategy for biological and toxicological testing protocol for current and future products.
* Develops and executes plans to build scientific expertise required to critically review scientific results and publications and present written and oral briefings to regulatory agencies and other external scientific and government agencies. Expertise in toxicology, epidemiology, biomarkers of harm, clinical trial methodology, cessation, and addiction and dependence must be maintained internally and through rPelationships with outside consultants.
* Coordinate effectively and collaboratively with other departmental leaders and senior management to solve problems and take competitive advantage deriving from dynamics of product provides ongoing assessment of scientific literature relating to technical issues.
* Develops sound scientific relationships with external groups; identifies and engages with external groups that could assist the Company agenda; represents the Company in trade associations and to government agencies.
* Consults with and assists senior management and Company legal counsel in responding to scientific issues and questions arising in litigation, and with respect to regulations and legislation.
* Manage and oversee financial and budgetary aspects related to the Product & Regulatory Affairs agenda/department, properly recommends and justifies needed capital expenditures
* Lead and develop direct reports (Regulatory Toxicologist / Regulatory Analyst) and actively participate to broader competency development agenda, to include training, performance reviews and mentoring
KNOWLEDGE AND SKILL REQUIREMENTS
* PhD in Physical or Biomedical Sciences with 10 years experience managing toxicological programs and/or regulatory issues. An equivalent combination of degree plus experience will also be considered.
* Direct experience creating and implementing the strategic direction of a company or business unit
* Demonstrated achievement in a management or leadership role.
* Ability to organize and prioritize tasks and reconcile conflicting demands.
* Proven successful program and project management skills.
* Experience in positions requiring budget understanding and resource forecasting and management
* History of technical accomplishments as evidenced by publications and/or patents.
* Broad scientific outlook and business perspective.
* Excellent influencing and negotiating skills.
* Ability to lead, motivate and coach in a diverse and collaborative work environment.
* Direct and articulate verbal and written communication skills and effective interpersonal skills
* Demonstrated effectiveness in providing compelling written submissions and oral presentations to regulatory or government agencies.
* Experience in protocol development and administration of external clinical studies.
* Experience in FDA regulated industry.