The Director Regulatory Affairs position is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned development teams. Continually expands therapeutic are and disease state knowledge. Ensures strategic messaging and content of global regulatory dossiers. Serves as primary regulatory interface with health authorities. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Serves as resource to team members for the regulatory requirements, processes, and logistics to conduct global drug development activities for compounds from the preclinical stage through approval, initial marketing, and life cycle management. Demonstrates excellent understanding of drug development and leadership behaviors consistent with the level. Provides leadership and acts as a resource to the broader regulatory function, including peer mentorship of junior staff.

Primary Responsibilities

• Interfaces with cross-functional teams to lead and support company objectives. Leads the regulatory project team to development of creative global strategies in line with applicable regulations to achieve business objectives for development and/or marketed products.
• Leads cross-functional stakeholders to ensure appropriate and clear strategic messaging in global regulatory dossiers and responses to requests from health authorities.
• Key internal leader and driver of regulatory policy and strategy for assigned products
• Leads preparation of global regulatory product strategies for assigned products. Leads regulatory and cross-functional team in the preparation and maintenance of risk assessment and mitigation strategies and communicates plans to relevant stakeholders.
• Proactively researches and presents regulatory assessments and recommendations.
• Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives.
• Maintains compliance with reporting requirements for existing applications (IND, NDA, MAA). Prepares and submits all maintenance submissions.
• Participates in professional associations, industry, and trade groups to keep current on regulatory intelligence and applying knowledge to assigned programs.
• Works independently under the direction of supervisor.

Education/Experience/Skills

• Bachelor's degree in a life science or related field.
• Targeting 10years progressively responsible experience, with 5 years in a leadership role.
• Experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU, Canada, or Japan.
• Strong global development foundation with business acumen.
• An equivalent combination of relevant education and experience may be considered.

Key Qualifications:

• Strong knowledge of different functional document types that comprise eCTD regulatory submissions including clinical documents and other reports.
• Experience in supporting global clinical trial applications via CROs (e.g. CTIS).
• Ability to communicate clearly and concisely, both in writing & verbally, with others in a professional manner.
• Keep abreast and analyze of submission and data standards, regulatory policies, procedures, security standards, GMP, and GCP.
• Ability to work cross-functionally to solve complex business process and technical problems, escalating concerns to senior management as appropriate.
• Ability to schedule team priorities with minimal supervision.
• Ability to work efficiently in a fast-paced environment where priorities change frequently to meet the business needs.

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 15 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business issues.

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