Director, Regulatory Affairs

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Job description

Position Summary

Provides regulatory expertise and support for pre-clinical, clinical, and commercial areas for investigational and marketed products. Ensures development of drugs are in accordance with global regulations in order to approve drugs quickly and smoothly within typical approval timeframes. Ensures marketed products are supported with minimal questions and issues from the regulatory agencies. Works with Regulatory Management to establish well-defined regulatory pathways and creates accurate and timely documents for IND and NDA submission and final approval.

Job Responsibilities

• Provides strategic regulatory leadership and guidance to the project teams in the planning and execution of global investigational and marketed prescription drug submission.
• Leverages regulatory intelligence, precedent approvals and prior health authority decisions to develop a robust regulatory strategy that supports development of strategic options for assigned Otsuka products.
• Translates complex pertinent global requirements, provides an assessment of the associated regulatory needs and incorporates into the development of the global regulatory plan with the assigned project teams, and internal/external functional business units as needed.
• Develops strategies, drafts responses, and/or reviews responses and documents intended for submission to FDA or other health authorities to assure compliance with regulatory standards.
• Designs programs for complete and accurate IND/CTA submissions and ensures that clinical trials are designed to meet regulatory requirements.
• Defines regulatory expectations for teams, identifies elements of INDs, and FDA requirements (and other Health Authorities in collaboration with regional regulatory affairs for CTAs), develops positions for responses to regulatory agencies, defines strategy for negotiations and formal document submission, and provides strategic input in the development of the plan.
• Interacts with regulatory agencies and ensures conversations and communications are focused, amicable, documented and meet the objectives for the development of the product.
• Oversees the submission of product registration of new drugs, progress reports, supplements, amendments, aggregate reports and periodic adverse experience reports.
• Supports the planning, writing and review of key dossier documents for submission globally.
• Oversees the review of documents/reports generated by RA support staff or contractors or other project team members to assess the likelihood that the content will meet pre-specified objectives, and provides input towards this end.
• Prepares submissions to health authorities working with Regulatory Operations and support staff.
• May participate in regulatory due diligence activities for licensing candidate review.
• May serve as part of Global Product Development Committee, monitoring the products with the affiliates as well as co-licensing partners Member or Co-Chair of the Clinical - Regulatory Sub team/Product Development Committees.
• Trains, and coaches staff; evaluates employee performance on an ongoing basis for direct (if any) or indirect reports, and completes annual performance reviews as appropriate.
• Supports or leads non-project activities e.g. SOP/standards development, organizational initiatives, etc.

Knowledge, Skills, and Competencies

Knowledge

•Comprehensive knowledge of the drug development process, drug laws, global

regulations, and guidelines.

• Good understanding of the global regulatory agencies.

• Proven success of submitted sNDA, IND and NDA.

Skills

• Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word,

Excel, PowerPoint, and Outlook).

• Strong analytical skills and problem solving ability.

Leadership skills that can influence cross functional teams or committees to meet project goals

• Strong communication and presentation skills.

• Knows how/when to apply organizational policy or procedures to a variety of situations.

Competencies

See OPDC Competencies Chart. (Level 5)

Physical Demands and Work Environment

Travel (approximately 20%)

See document Physical Demands and Work Environment for further requirements.

Education and Related Experience

Bachelor's degree with 10 years experience in regulatory affairs or related areas (e.g. clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Direct or indirect supervisory and medical device experience a plus.

Experience with FDA, other health authority, or project meetings/ interactions desirable.

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Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

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