Overview:
We are seeking an accomplished and visionary Executive Director of Regulatory Affairs to lead our regulatory strategy and compliance efforts. This strategic leadership role involves overseeing regulatory affairs, shaping global regulatory strategies, and ensuring compliance with applicable regulations in the life sciences industry.
Responsibilities:
Develop and execute global regulatory strategies, ensuring alignment with corporate objectives and industry best practices.
Provide strategic leadership in regulatory affairs, overseeing regulatory submissions, approvals, and compliance activities for all products or initiatives.
Directly interact with regulatory agencies, fostering positive relationships and representing the organization in regulatory matters.
Lead and mentor a team of regulatory professionals, providing guidance, mentorship, and fostering a culture of excellence and compliance.
Collaborate cross-functionally with R&D, clinical, marketing, and legal teams to ensure regulatory considerations are integrated into product development and commercialization strategies.
Monitor changes in regulatory requirements and industry trends, providing guidance and proactive solutions to mitigate risks and capitalize on opportunities.
Requirements:
Advanced degree in a relevant scientific discipline, life sciences, or a related field.
7+ years of extensive leadership experience in regulatory affairs within the life sciences industry, preferably in progressively senior roles.
Proven track record of developing and implementing successful global regulatory strategies resulting in successful product approvals.
In-depth knowledge of FDA, EMA, and other global regulatory requirements and procedures.
Strong leadership, decision-making, and problem-solving abilities.
Exceptional communication, negotiation, and interpersonal skills.
Benefits:
Competitive executive compensation package with comprehensive benefits.
Opportunities for professional growth and career advancement in a leading organization.
Collaborative and innovative work environment.
Health and wellness programs.