Senior Manager, Global Regulatory Affairs

Otsuka Pharmaceutical Co., Ltd; Northern (KY); Hybrid; USD 150,000 - 224,000; Full time

Benefits offered by this job

Comprehensive benefits

Job summary

Otsuka Pharmaceutical Co., Ltd. seeks an experienced Regulatory Affairs professional to develop and execute global regulatory strategy for investigational and marketed prescription drugs, coordinating with the Global Regulatory Lead and cross‑functional teams.

You will manage submissions (INDs, NDAs/MAAs), regulatory intelligence, health authority interactions, and lifecycle activities, ensuring compliance with FDA/ICH and EDMS practices; travel approx. 20%.

Qualifications

• Bachelor’s degree in regulatory affairs or related field with 5+ years’ experience in regulatory affairs.
• Master’s degree in regulatory affairs or related field with 2+ years’ experience is acceptable.

Responsibilities

• Develop global regulatory strategy and plan for investigational and marketed products.
• Lead and coordinate regulatory submissions (INDs, CTAs, NDAs/MAAs) and responses to health authorities.
• Provide regulatory intelligence and assessment of global requirements to GRL and project teams.
• Collaborate with GRL, regional leads, and cross-functional teams to address regulatory issues and obligations.
• Ensure documents are accurate, compliant, and high-quality for approvals.
• Interact with health authorities and act as sponsor contact when needed.
• Drive departmental initiatives to improve efficiency, quality, and output.

Skills

Regulatory strategy

Regulatory intelligence

Regulatory submissions

Cross-functional leadership

FDA/ICH knowledge

EDMS familiarity

MS Office proficiency

Education

Bachelor's degree in regulatory affairs or related field

Master's degree in regulatory affairs or related field

Tools

EDMS

Microsoft Office

Job description

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

• 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, prioritized work, 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.

Salary

Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform 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.

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 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 [e-mail].

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position 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. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine. Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023.

We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.