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.

• 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.

• 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.

• 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).

See OPDC Competencies Chart (Level X)