RESPONSIBILITIES:
- Provides leadership and management to the RA functions
- Oversees the establishment and maintenance of the RA programs, policies, and procedures
- Provides oversight and guidance to ensure compliance with all applicable regulations and guidelines
- Directs all regulatory activities to support development and commercialization of products and product candidates
- Represents the company to regulatory authorities
- Supports clinical studies including, clinical study design, data analysis, and data reporting
- Ensures appropriate regulatory representation and strategic regulatory input to cross-functional product development teams
- Responsible for keeping Executive Leadership Team informed of regulatory status of products and regulatory issues
- Ensures regulatory support of pharmaceutical development, manufacturing operations, conduct of clinical and nonclinical studies, and marketing and sales activities
- Oversees regulatory filings to ensure accuracy, quality and compliance
- Collaborates with cross-functional partners to ensure successful global development, registration planning and implementation
- Leads and develops RA staff to ensure ongoing professional development
- Communicates regulatory policies and provides clarity on regulatory expectations
- Responsible for regulatory review and approval of documents, as required
- Analyzes the global regulatory requirements and environment, and provides assessments of the impact of new and changing regulations
- Other duties as assigned
EDUCATION AND EXPERIENCE:
- Bachelor’s degree in life sciences or a related field required. Advanced degree preferred
- At least 10 years’ experience in the pharmaceutical/biotechnology industry within Regulatory Affairs function with meaningful oncology experience
- Experience with regulatory submissions including IND’s, CTAs, and marketing applications
- Strong knowledge of applicable regulatory requirements including but not limited to GXPs
- Previous experience interacting with FDA, EMA and other regulatory agencies
- Very strong written, verbal, and interpersonal communication skills
- Ability to work independently and in close collaboration in a cross-functional team setting