SUMMARY:

Fortvita Biologics is seeking a Senior Manager/ Associate Director of Regulatory Affairs US Lead, supporting the department head for developing and implementing global strategies to secure and maintain market approval for product(s) globally (US, EMA, Japan, Australia, Canada). The incumbent is the US-Regulatory Leader. Serves as the primary regulatory interface with the product development team and supporting functions. Proactively anticipates and mitigates regulatory risks. Ensures compliance with US regulatory requirements. Demonstrates leadership behaviors to build a cohesive team environment. Must have a solid understanding of drug development, regulatory requirements, Develops and implements accelerated submission strategies.

DUTIES AND RESPONSIBILITIES:

• Primarily function as a US-Regulatory Leader and is responsible for ensuring the execution of regional regulatory strategy in line with the global registration strategy of a project in collaboration with the Global Regulatory Leader (GRL).
• Provide regulatory support from proof of concept (PoC), development, registration, and post-approval for projects within the company’s portfolio.
• Depending on the candidate’s skill-set, may also be assigned as a Global Regulatory Leader (GRL) with full regulatory responsibility for one or more earlier stage.
• Leads and coordinates local project team members in developing strategy for applicable documents/activities.
• Ensures quality and content of submissions to Health Authorities.
• Depending on skill-set and as deemed appropriate by the GRL, may lead regional Health Authority meetings and liaison with local Health Authority and company governance boards for assigned projects.
• Depending on the skill-set and as deemed appropriate by the GRL, may be the document owner of briefing books to Health Authorities.
• Assist with development of the global regulatory functional plan through the research, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling.
• Experience reviewing nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, Investigator Brochures, CMC information/data) and contribute to content as needed.
• This position has a moderate-high level of autonomy with growth opportunity. Able to work in a Fast-paced environment handling multiple demands is preferred.

QUALIFICATIONS:

Qualification Requirements:

• Advanced scientific degree (i.e., PhD, MD, PharmD) or master’s degree with at least 5 years of drug development experience. Experience in Oncology is a great plus.
• Global Experience is a plus.

Other Information/Additional Preferences:

• Travel expected (10%)
• Knowledge of Global regulatory procedures and practices and awareness of evolving regulatory reform initiatives desirable
• Demonstrated deep knowledge of the integrated drug development process and regulatory/business strategies
• Strong written, spoken and presentation communication
• Demonstrated attention to detail