Collaborates with client’s project team members and key decision makers to gain a complete understanding of a product and transforms that knowledge into an actionable regulatory strategy.
Responsible for implementing the strategy, which often entails engaging regulatory authorities, authoring submissions, and interacting with the authorities throughout the regulatory review.
Deliver full-service oversight and consultation to clients by providing strategic regulatory considerations and paths to market, combined with a commitment to getting products approved in various regions.
Collaborate with clients’ project team members and key decision makers to gain a complete understanding of the product and goals and transform that knowledge to a strategy that balances risk with potential regulatory outcomes of proposed paths in a way that clients can understand and apply in decision making.
Identify, propose, plan, and direct regulatory projects, transforming the regulatory strategy into executable project plans that achieve desired results and timelines.
Serve as a trusted intermediary with health authorities to build and maintain a positive relationship on behalf of clients.
Negotiate with health authorities during the development and review processes to ensure productive submission process.

Bachelor’s degree in scientific discipline; advanced degree preferred.
Minimum of 10 years of experience in Regulatory Affairs or Regulatory Consulting in the pharmaceutical industry.
Proven experience in providing strategic regulatory advice to clients.
Applied expertise within the product development life cycles.
Effective verbal and written communication skills with internal and external stakeholders; strong negotiation and influencing skills.
Ability to explain reasoning led to conclusions in both written and oral formats.
Strong project management skills; knowledge and implementation of process and planning best practice; ability to manage risk and communicate it effectively.
Ability to manage multiple projects, priorities, and deliverables in a timely fashion.
Prudent and practical decision-making abilities, a team player, and can work independently without direct supervision.
Self-motivation, good judgment, strong follow-up, organizational, analytical, and problem-solving skills.
Excellent leadership, communication, and interpersonal skills.

Director, Global Regulatory Affairs

Key skills