Director, Regulatory Affairs

Position Summary

Leads global regulatory strategies and guides cross-functional teams to assure drug products and devices are developed in line with the applicable regulatory requirements of targeted countries and obtains license approvals (e.g., IND, NDA, ANDA, 510k) and registrations or authorizations for these products to bring safe, approved medicines and devices to market. Maintains registrations of existing drug products and devices in compliance with applicable regulations. Prepares and submits post approval reports as required by the US regulations and other regulatory agencies where the product is licensed. Represents the company in all Regulatory interactions with Health Regulatory Authorities in the US and worldwide, as applicable.

Essential Duties & Responsibilities

• Develops and implements regulatory strategies for development projects and manufacturing improvements and analyzes risk vs. benefit in regulatory strategies to ensure compliance with regulatory requirements and successful review by regulatory authorities.
• Manages team’s preparation of registration packages and responses to deficiency letters to ensure high quality submissions with effective presentation. Negotiates and influences submission data requirements and deliverable dates with regulatory authorities as necessary and communicates to internal technical teams.
• Acts as a point person for regulatory agency interactions (either written or oral) including preparation of briefing packages and strategy for meetings, inspections, advisory committee meetings, and responses to agency letters pertaining to the assigned products/teams.
• Maintains awareness of global regulatory legislation and assesses its impact on business and product development programs. Identifies new requirements or changing landscape and can lead implementation of these new or updated processes/requirements within the regulatory organization.
• Provide managerial support and training to employees by supervising staff, establishing employee goals that align with other business partners, maintaining job descriptions, creating employee development plans, providing performance feedback, and recruiting and retaining staff members.
• Work special projects as assigned.

Knowledge & Skills

• Interprets global regulations to assure regulatory compliance, minimize product cost and reduce development cycles.
• Strong critical thinking, negotiation, and matrix-leadership skills to guide multidisciplinary teams and influence senior management.
• Develop effective regulatory strategies, as per market plan.
• Negotiates reasonable and attainable regulatory strategies that are innovative, compliant, and sound from a business and technical perspective.
• Follows scientific arguments, identifies regulatory scientific data needs, and solves regulatory issues.
• Performs complex compliance risk/benefit analysis in formulating a recommendation for action.
• Directly influences the development of new products and improvements to existing products, which can increase sales and/or reduce compliance risk.
• Approves regulatory data packages and labeling prior to filing and during the approval process. Identifies submission risks and develops mitigation plans to minimize time to regulatory approvals.
• Establish optimal regulatory strategies and successfully negotiates with regulatory agencies when necessary. A successful regulatory strategy can have a critical impact on eventual revenue by early approval with the best possible label/product claims.
• Independently represents Otsuka ICU Medical to external global agencies, business partners, and industry groups.
• Analyzes and interprets complex scientific data to best position in global registrations.
• Assesses scientific data provided for registration purposes against regulatory requirements.
• Influences scientists to present complex scientific data to meet the needs of individual regulatory agencies.
• Summarizes complex technical data and presents strategies and data to management and regulatory agencies.
• Assesses impact of emerging regulations and legislation on program objectives and regulatory strategies.
• Data analysis and critical thinking skills are essential to critique summarized analytical, engineering, clinical and statistical data and propose recommendations on data presentation and utility.
• Acts independently on most tasks. Directs submission related activities by leading the team and motivating the staff to successfully execute regulatory strategies.
• Effectively assigns team membership, plans and prioritizes workload, follows up to assure success.
• Establishes regulatory commitments, strategy decisions, meeting strategies with regulatory authorities and changes to resource allocations.
• Prepares teams for agency meetings and leads discussion at regulatory agencies.
• Effectively represents the company at external settings.
• Assists in the training, mentoring, management, and development of individuals on the team.
• Effectively utilizes networks to identify regulatory talent and influence industry positions.

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age.
• Bachelor’s degree (STEM) from an accredited college or university is required.
• Advanced degree preferred (PhD, PharmD, MD, or MS)
• Minimum of 10 years’ experience in pharmaceutical drug manufacturing and/or development, with a proven track record in leading major regulatory submissions.
• Minimum of 5 years management experience in regulatory affairs, global regulatory affairs experience is required.
• Experience working directly with regulatory agencies (e.g., FDA, Health Canada).
• Sound knowledge of applicable portions of agency guidance and regulations.
• Excellent communications skills at all levels - both internally and externally.
• Highly proficient in communicating strategic and tactical issues to management.
• Strong interpersonal skills.
• Proven negotiating skills.
• Demonstrated leader.

Work Environment

• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.