Director/Senior Director, Regulatory Policy

Alternative Resources Company

Director/Senior Director, Regulatory Policy

Director/Senior Director, Regulatory Policy
 
This role is a unique opportunity to shape policies that will help advance the use of real-world evidence for oncology medical product development and regulatory decision making through work with internal and external experts including life science partners, regulators, policy makers and other thought leaders. In this role, you will provide regulatory policy intelligence and knowledge to internal teams, drive the company’s advocacy agenda, including through alliances, and manage key external relationships to advance regulatory policies. A deep understanding of both medical product laws and regulations and the policy making process are critical for this role.
 
Responsibilities
  • Work collaboratively with internal and external stakeholders to influence the regulatory policy environment and advance FDA, EMA and PMDA guidelines for the use of real-world evidence
  • Evaluate and disseminate the latest regulatory policy intelligence to internal stakeholders and contextualize the impact on the business
  • Serve as a liaison for regulatory policy-focused projects and cross-functional initiatives
  • Develop a stakeholder strategy and manage relationships with patient advocates, academics, and others
  • Collaborate closely with life science partners and allied organizations on joint advocacy
  • Collaborate and reliably share feedback from regulatory bodies and clients with the team of product managers, engineers, business development leaders, and other cross-functional colleagues.
  • Help develop regulatory policy positions in collaboration with internal stakeholders and draft public comments in response to regulations and guidance issued by regulators and health authorities
  • Gather regulatory policy intelligence, analyze changes in the regulatory environment, and work closely with internal subject matter experts to assess the impact of regulatory policies on the business’ goals
  • Propose and respond to draft legislation, regulations, guidelines and policies related to the use of real-world evidence
  • Manage select meetings with FDA and other health authorities as assigned
  • Provide insights and advocate for positions on critical regulatory trends in support of a broader policy platform
  • Build influence through engagement in relevant trade associations, coalitions and alliances
 
Qualifications
  • Regulatory policy expert and leader with at least 5 years of federal policy experience within a relevant organization (e.g., life sciences industry, leading policy think tank, or regulatory agency such as FDA).
  • Solid track record of regulatory policy achievements within biopharma, a real-world data organization or a similar industry and ideally, an advanced scientific or medical degree (e.g., MS, PharmD, PhD, MD, NP)
  • Solid knowledge of laws, regulations and guidance related to medical product development and approval, preferably with both the US FDA and EMA
  • Fluent knowledge of drug development; experience with real-world evidence, oncology. An understanding of regulations pertaining to medical software and digital health highly desirable
  • Experience synthesizing input from cross-functional teams
  • Strong organizational, interpersonal and networking skills
  • Outstanding communication skills (written and verbal, both formal and informal)
  • Ability to manage multiple projects simultaneously in a fast-paced environment
  • Effective at driving collaboration, achieving results, influencing, and resolving conflicts across internal and external stakeholders
  • Ability to roll up sleeves to tackle meaningful problems every day, with a forward-looking mentality as it relates to regulatory policy strategies.
  • Collaborative problem solver who seeks and gives candid feedback and values the chance to make an important impact.
  • Deep knowledge of regulatory policy related to the use of real-world evidence for regulatory decision making preferred
  • Experience in policies related to personalized medicine and an understanding of the current oncology product landscape preferred
  • Experience with medical device regulations, including software as a medical device preferred
  • Working knowledge or expertise in policies related to the use of AI and machine learning preferred
  • Worked for a medical product regulatory or health authority preferred