Senior Manager of Regulatory Affairs
The Opportunity: Senior Manager of Regulatory Affairs
- Manage planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities. Such submissions may include Clinical, Preclinical, or CMC content.
- Correspond and collaborate with RevMed colleagues and departments to achieve alignment.
- Function as a Regulatory Affairs subject matter expert member of 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 executive 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.
- 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.
- Knowledge of EU EMA and Rest Of The World Pharmaceutical regulations and guidance preferred.
- Direct experience with IND/NDA filings.
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