Senior Manager, Regulatory Affairs
About The Position
The Senior Manager of Regulatory Affairs will provide project teams with regulatory advice, manage and coordinate various Regulatory Affairs activities and deliverables within and between departments, and obtain and maintain National Health Authority approvals for investigational products. The position may also undertake regulatory intelligence and research supporting company decision-making as well as regulatory project management to support RA deliverables. 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.
Requirements
- Bachelor's Degree in a relevant field and at least 10 years of Regulatory experience
- Strong working knowledge of US FDA Pharmaceutical regulations and guidance
- Previous experience in oncology
- Proven track record of successful management of 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
Nice To Haves
- Knowledge of global regulations and guidance preferred.
- Experience with supporting the preparation and submission of large complex regulatory submissions, including NDA’s.
- Excellent written and verbal communication skills.
Responsibilities
- Provide project teams with regulatory advice
- Manage and coordinate various Regulatory Affairs activities and deliverables within and between departments
- Obtain and maintain National Health Authority approvals for investigational products
- Undertake regulatory intelligence and research supporting company decision-making
- Regulatory project management to support RA deliverables
- Manage planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
