Director, Regulatory Affairs

Role Summary

Director, Regulatory Affairs. Responsible for developing, implementing, and advising on North America regulatory strategies for development programs to secure and maintain market access in NA, in coordination with the global regulatory leader and internal stakeholders. Manages NA regulatory aspects through all development phases, post-approval, and life cycle; provides leadership and regulatory oversight from a NA perspective; interfaces with regulatory agencies (FDA, Health Canada) and business partners; provides line management and supports department policy development.

Responsibilities

• Provides high level regulatory strategic and operational direction for NA and mentorship on projects, including regulatory strategies, regulatory requirements for clinical studies and marketing approval, regulatory strategic development plans and risk assessments, issue management, and FDA/Health Canada interactions.
• Applies extensive knowledge of US regulatory requirements to development projects and marketed product regulatory issues to support corporate goals.
• Oversees preparation and submission of documentation to support investigational and marketing registration packages in the US and Canada, ensuring timelines align with global strategy.
• Reviews sections of documents for clinical trials and marketing applications to conform with local regulatory requirements.
• Liaises and negotiates with the FDA and Health Canada for drug development, issue resolution, and expediting approvals of product and labeling changes.
• Maintains awareness of the global regulatory environment and assesses impact on business; facilitates policy and interpretation of global regulation.
• Integrates functional expertise with business knowledge to solve problems and make decisions for the business.
• Trains, develops, and manages an effective regional regulatory team; manages direct and indirect reporting.
• Builds partnerships with senior stakeholders from other functions to meet strategic business goals through knowledge sharing.
• Manages critical regulatory issues and contributes to regulatory processes development and implementation.
• Recruits, develops, manages, and mentors regulatory professionals and fosters a goal-oriented culture.

Supervisory Responsibilities

• Some supervisory responsibilities for multi-level regulatory team(s).

Computer Skills

• Experience with Microsoft Office suite
• Veeva regulatory publishing
• PowerPoint presentation authoring and presentation

Other Qualifications

• 10+ years of experience in the biotechnical or pharmaceutical industry, with a minimum of 5 years in a Regulatory capacity; broad background.
• Bachelor‚Äôs degree required; advanced degree preferred.
• Experience leading Regulatory Affairs with the FDA; prior experience with small molecules and biologics preferred.
• Thorough understanding of the drug development process and regulatory requirements and policy trends.
• Extensive regulatory experience with INDs/CTAs, NDAs/BLAs, lifecycle management, interactions with Health Authorities; leading/regulatory teams; developing/regulatory strategies with a track record of accomplishments.
• Strong business acumen and decision-making ability; strategic skills to address major challenges and balance short-term needs with long-term vision.
• Proven ability to deliver goals in a cross-functional environment; professional communication skills; ability to convey complex issues clearly.
• Conflict resolution/negotiation skills; fosters open communication; creative problem-solving.
• Proven ability to build trust and respect within the organization; ability to prioritize and manage multiple projects.
• Interacts with external business partners and Regulatory Agencies.

Education

• Bachelor‚Äôs degree required; advanced degree preferred.

Travel

Business travel to be 10-20% as required.