Manager of Regulatory Affairs
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 company 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.
Bachelor's Degree in a relevant field and at least 3 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 Pharmaceutical regulations and guidance preferred.
Direct experience with IND/NDA filings.
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