Otsuka America Pharmaceutical Inc.
Senior Manager, Global Regulatory Affairs
Otsuka America Pharmaceutical Inc., Madison, Wisconsin, us, 53774
Position Summary
Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and managing lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Job Responsibilities
Supports development of 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. 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 the global regulatory team 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 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. Assesses and develops 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 and 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, prioritize work, proactively manage and communicate issues, scope 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 and ability to learn and grow. Competencies See OPDC Competencies Chart (Level X) Physical Demands and Work Environment
Travel (approximately 20%). 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. Compensation
Minimum $146,955.00 – Maximum $219,650.00, plus incentive opportunity. Application Deadline
This position will be posted for a minimum of 5 business days. 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, generous 401(k) match, flexible time off, paid holidays and paid leave programs. Equal Employment Opportunity
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.
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Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and managing lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Job Responsibilities
Supports development of 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. 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 the global regulatory team 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 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. Assesses and develops 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 and 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, prioritize work, proactively manage and communicate issues, scope 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 and ability to learn and grow. Competencies See OPDC Competencies Chart (Level X) Physical Demands and Work Environment
Travel (approximately 20%). 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. Compensation
Minimum $146,955.00 – Maximum $219,650.00, plus incentive opportunity. Application Deadline
This position will be posted for a minimum of 5 business days. 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, generous 401(k) match, flexible time off, paid holidays and paid leave programs. Equal Employment Opportunity
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.
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