Senior Director Regulatory Affairs

The Senior Director of Regulatory Affairs will spearhead the regulatory strategy. This role involves close collaboration with cross-functional teams within the company and with external business partners to prepare, review, and finalize regulatory submissions. The Senior Director will also play a pivotal role in evolving and expanding the regulatory team to support the company's growth

Key Duties and Responsibilities

• Develop and lead regulatory strategies for complex projects from initial human trials to post-marketing stages, as detailed in Global Regulatory Strategy Documents. This includes overseeing regulatory submissions and Health Authority communications.
• Represent Global Regulatory Affairs (GRA) on core development and project teams, collaborating with regional leaders to ensure cohesive regulatory input into clinical programs and commercial strategies.
• Address complex regulatory issues by providing advanced solutions and guidance to cross-functional teams, ensuring alignment in communications with GRA leadership. Advise senior management on the status of global regulatory strategies, tactics, and practices.
• Oversee the creation and management of project plans and timelines, effectively assigning and managing resources to ensure timely achievement of key goals.
• Influence the regulatory environment through active involvement in industry conferences, regulatory meetings, committees, and trade associations. Stay current on evolving regulations, policies, and competitive issues affecting regulatory strategy.
• Lead continuous improvement efforts within the department, offering recommendations based on expertise.
• Manage GRA functional teams, including coaching, skill development, and performance feedback for team members.
• As a people manager, may have responsibilities for financial oversight and human resource management of assigned staff.

Knowledge and Skills

• Strategic thinker with a business-oriented approach, capable of proposing innovative solutions to regulatory challenges.
• Excellent communicator, able to impact and influence team decisions, interact effectively at all company levels, and serve as a liaison internally and externally. Proficient in verbal presentations and written documentation of regulatory strategies and submission documents.
• Strong regulatory leadership in a cross-functional and matrix environment.
• Deep technical expertise in regulatory affairs, including knowledge of global, regional, and local regulations, legislation, and guidance related to pharmaceutical development. Demonstrated understanding of research, development, preclinical, and clinical requirements for drug development and maintenance.
• Advanced skills in analyzing and interpreting data, protocols, safety reports, labeling, and other drug development activities.
• Expertise in creating and evaluating proposals to regulatory authorities and leading effective health authority interactions, including well-organized preparation of cross-functional teams.
• Skilled in assessing regulatory pathways and strategies, providing recommendations for adjustments based on ongoing outcomes.
• Ability to articulate the organization's strategic vision and core values, contributing to the enhancement of internal regulatory policies, programs, and initiatives.
• Strong leader with cultural sensitivity, commitment to diversity, and a focus on staff development through feedback, coaching, and mentoring.