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Position Summary
Provides global regulatory expertise to pre-clinical, clinical, and commercial areas for investigational and marketed products. Ensures that regulatory/competitive intelligence, or scientific/regulatory information searching, summarization, assessment and dissemination are provided to the Otsuka organization. Collaborates with Regulatory Management to establish clear regulatory pathways and creates accurate and timely documents for submission and final approval.
Job Responsibilities
Under the direction of the Senior Director or Executive Director, Global Regulatory Affairs provides strategic regulatory guidance developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Therapeutic Area Lead (TAL).
Identifies the need and obtains regulatory intelligence, researches precedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products.
Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed.
Lead Cross Functional Team to collaboratively develop a global regulatory plan, address global regulatory issues, respond to health authority queries, and meet regulatory obligations.
Develops and leads strategy for Health Authority interactions/communications through submissions and responses to regulatory authorities within company timelines and inaccordance with regulations and guidelines.
Reviews submission documents to ensure they are aligned with the strategic approach developed by the cross functional team
Designs programs for complete and accurate IND/CTA/NDA submissions and ensures that clinical trials are designed to meet regulatory requirements.
Supports development of strategies, drafts responses, and/or reviews responses and documents intended for submission to FDA or other health authorities to assure compliance with regulatory standards
Reviews submission documents for consistency and ensures they are aligned with strategic approach developed by the team.
Interacts with regulatory agencies and ensures conversations and communications are focused, amicable and Documented.
Contributes to the submission of product registration of new drugs, progress reports, supplements, amendments, aggregate reports and periodic adverse experience reports.
Collaborates and provides oversight to outsourced suppliers of regulatory support in the preparation of documents/reports.
Identifies early major regulatory issues and ensures these are communicated to relevant stakeholders in a timely manner.
May serve as part of Clinical Regulatory and labeling teams as needed.
Supports or leads projects and non-project activities e.g. SOP/standards development, organizational initiatives, as needed. 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.
* Experience leading submission of CTA, IND, sNDA/NDA/MAA/Variation.
Skills
Strong information searching, summarization and assessment skills.
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.
Strong communication and presentation skills.
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 8+ 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.
Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication -Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.
Company benefits: comprehensive medical, dental, vision and prescription drug coverage, company provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings;https://www.otsuka-us.com/careers-join-otsuka.
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 be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request.
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