Associate Director, Regulatory Affairs

Essential Functions Of The Job

• Accountable for regulatory deliverables and milestones including the development of regulatory strategic and tactical plans.
• Provides strategic and operational regulatory direction on assigned projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval, risk assessments, critical issue management and advice on health authority interactions.
• Uses extensive knowledge of US, CAN, and ICH regulatory requirements with the ability to apply knowledge both strategically and with business needs and goals in mind.
• Responsible for managing decision-making, and conflict resolution surrounding regulatory issues within the Project Team. Responsible for ensuring appropriate escalation to functional management when necessary.
• Manage/oversee the preparation and submission of documentation to support investigational and marketing registration packages ensuring timelines are met.
• Review sections of IND/CTA, NDA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with regulatory requirements and strategies.
• Liaise and negotiate with regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of product and labeling changes.
• Maintain awareness of regulatory environment and assess impact of changes on business and product development programs.
• Facilitate policy and development of standard interpretation of regulations.
• Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business.

Qualifications

• Bachelor’s degree with 8+ years’ of related regulatory experience is required.
• PREFERRED: Experience working as a Project Lead in Regulatory Affairs, leading multiple FDA interactions. Experience should clearly be demonstrative of managerial, leadership, and collaboration ability across several functional areas.
• Advanced degree preferred.
• Experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, and developing and implementing regulatory strategies with a proven track record of accomplishments.
• Thorough understanding of the drug development process, the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends.
• Strong business acumen and ability to integrate multiple sources of data to make sound decisions that contribute positively to the business.
• Excellent verbal and written skills; able to analyze, define, and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders.
• Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion.
• Proven ability to build trust and respect within organization.
• Able to prioritize and handle multiple projects simultaneously.
• Supervisory Responsibilities Will line manage, and/or mentor, junior supporting staff. Train and develop an effective regulatory team both via direct and indirect reporting structure.