New York or Remote
This is an exciting and unique opportunity for a Director/Sr. Director of Regulatory Policy to take on a new challenge within a company that focuses on changing and enhancing drug development opportunities by capturing real world data to accelerate and generate evidence.
In this role you will lead, develop and implement regulatory policy and advocacy strategy to support and advance product development and regulatory decision making.
· Work with stakeholders to influence the regulatory policy environment and advance FDA, EMA & PMDA guidelines.
· Evaluate and circulate the latest regulatory policy intelligence to internal shareholders and advise on business impact.
· Operate as a liaison on regulatory focused projects and cross functional initiatives.
· Develop stakeholder strategy and manage relationships with patient advocates and academics etc.
· Collaborate with life science partners and allied organization on joint advocacy.
· Provide feedback from regulatory bodies and clients to internal teams including engineers, business development leaders and product managers.
· Gather regulatory policy intelligence, analyses changes in the regulatory environment and works closely with internal subject matter experts to assess impact of regulatory polies on business goals.
· Propose and respond to draft legislation, regulations, guidelines and policies.
· Manages meetings with FDA and health authorities as required.
· You will be a regulatory policy expert with at least 5-years’ experience of federal policy gained within the biotechnology or regulatory agency setting.
· Able to demonstrate a track record of regulatory policy achievements within Biopharma.
· Hold an advanced scientific or medical degree (MS, PharmD, PhD, MD or NP)
· Excellent knowledge of laws, regulations and guidance in relation to product development and approval.
· You’ll need to be a kind, passionate and collaborative problem solver
· Knowledge of drug development and ideally experience of medical software.
· Able to manage multiple, simultaneous projects within a fast paced environment.
· Experience within the Oncology therapeutic area is an advantage.
To be considered for this position or to find out further information on the role please e-you’re your resume to Gary.Crawley@cpl.com.