Regulatory Affairs Manager

Hybrid - 3 days onsite

6 month initial contract (likely exetnsion and convert to FTE)

Responsibilities :

• 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.

Required Skills, Experience and Education:

• 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.
• Experience within Oncology
• Direct experience with IND/NDA filings.

Preferred Skills:

• Knowledge of EU EMA Pharmaceutical regulations and guidance preferred.
• Small molecules experience preferred.