Senior Manager of Regulatory Affairs

Senior Manager of Regulatory Affairs The Senior Manager of Regulatory Affairs will provide clinical study and project teams with regulatory advice and manage, coordinate, and track various Regulatory Affairs activities within and between departments and Clinical Research Organizations (CROs), to obtain and maintain National Health Authority clinical trial approvals for investigational products. The position may also undertake regulatory intelligence and research supporting company decision-making, and support regulatory department initiatives. Manage planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities. Correspond and collaborate with colleagues and departments to achieve alignment. Function as a Regulatory Affairs subject matter expert member on cross-functional teams, including study teams and submission teams. Perform regulatory research to inform business strategy. Assess and communicate risks. Assure that there are no significant interruptions to the business due to regulatory compliance issues. Collaborates across the organization at all levels, across functional groups, and with senior management. Develop regulatory strategies to inform associated budgets, tools and specialized support necessary for efficient operations. Establish collaborative and effective relationships with colleagues in Clinical, Clinical Operations and Clinical Research Organizations to ensure cross-functional alignment and team effectiveness.

Required Skills, Experience and Education:

Bachelor's Degree in a relevant field and at least 5 years of direct Regulatory experience. Strong working knowledge of US FDA Pharmaceutical regulations and guidance. Proven track record of successful submissions within a regulatory environment. Exceptionally strong team player with excellent interpersonal and communication skills. Detail-oriented with strong organizational skills and high-quality standards.

Preferred Skills:

Knowledge of EU EMA and Rest Of The World Pharmaceutical regulations and guidance preferred, specifically EU CTR and other clinical trial regulations. Direct experience with IND and Clinical Trial Applications filings.