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Otsuka Pharmaceutical Companies (U.S.) · 3 days ago

Senior Manager, Global Regulatory Affairs

United States

Full-time

Remote

Senior Level

$147K/yr - $220K/yr

5+ years exp

Otsuka Pharmaceutical Companies (U.S.) is seeking a Senior Manager in Global Regulatory Affairs to provide critical support in developing global regulatory strategies and managing lifecycle activities for investigational and marketed prescription drugs. The role involves collaborating with global regulatory teams, preparing submissions, and ensuring compliance with regulations to facilitate timely approvals from health authorities.

Health CareMedical

Comp. & Benefits

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

Qualification

Global regulatory submissionsRegulatory intelligencePharmaceutical industry experienceRAC certificationDrug development processMicrosoft Office proficiencyOral communicationWritten communicationTeam leadershipOrganizational skills

Required

Experience working in the pharmaceutical and/or healthcare industry

Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA)

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)

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