Senior Manager, Global Regulatory Affairs

Position Summary Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. 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. Works collaboratively with members of the global regulatory team to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations. Job Responsibilities Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL). 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. Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations. Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs (as applicable) within company timelines and in accordance with regulations and guidelines. Independently manages preparation of INDs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines. Confirms submission documents are accurate, compliant, and high-quality to allow for smooth and expeditious approvals from regulatory authorities. Serves as the sponsor point of contact to the health authority. Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with GRL, to determine appropriate actions to meet timelines and/or resolve issues. Effectively manages and directs internal support staff and external consultants for assigned projects. Interacts effectively with internal/external functional business units to gather data and develop documentation required for on-time submissions. Works closely with GRA department to execute departmental initiatives to improve overall efficiency, quality, and/or output. Assess and develop innovative ideas to move GRA department to address current and future challenges. Knowledge, Skills, and Competencies Knowledge Experience working in the pharmaceutical and/or healthcare industry. Knowledge experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). RAC certification a plus. Skills Strong oral and written communication skills. Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc. Able to successfully interpret and apply regulatory intelligence to work output. Ability to lead teams, prioritized, proactively manage and communicate issues, scopes progress and risks throughout the project lifecycle ensuring key stakeholders are informed. Able to establish close communications and working relationship with cross functional teams to meet business objectives. Results-oriented, entrepreneurial, and self-motivated with excellent organizational skills with ability to learn and grow. Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS). Competencies See OPDC Competencies Chart (Level X) 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 5+ years’ experience or Master’s degree with 2 years’ experience in regulatory affairs or related areas (e.g., clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable. 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. Compensation Range Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. Application Deadline This will be posted for a minimum of 5 business days. Company Benefits Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Benefits Link Come discover more about Otsuka and our benefit offerings; Equal Opportunity Employer Statement 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. Disability Accommodation 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 (View email address on click.appcast.io). Statement Regarding Job Recruiting Fraud Scams At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website Contact for Scam Alerts If you suspect a position is fraudulent, please contact Otsuka’s call center at: View phone number on click.appcast.io. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities. Application Process Notes Otsuka does not accept unsolicited assistance from search firms for employment opportunities. All resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written agreement will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. #J-18808-Ljbffr Otsuka America Pharmaceutical Inc.