Responsible for developing and implementing and leading short- and long-term global regulatory strategies that support the success of investigational and marketed pharmaceutical products throughout their lifecycle. These robust and expeditious strategies extend from R&D through post-marketing, in accordance with global regulations. Applies regulatory intelligence and expertise to effect innovative regulatory pathways and solutions to complex global requirements.
Leads and defines global regulatory strategy for all assigned R&D and marketed projects, working with the Global Regulatory subteam (regional leads, CMC-RA, labeling, medical writing, regulatory operations) to develop and execute robust regulatory strategies.
Serves as primary liaison to FDA and provides strategic input to the regional leads responsible for ex-US regulatory activities.
Represents Global Regulatory Affairs as the primary contact on regulatory aspects of the projects and as a member of the cross-functional project team, providing regulatory guidance/strategy/perspective in team meetings and presentations at senior leadership governance meetings.
Provides regulatory intelligence assessments to Global Regulatory teams and cross-functional team as needed.
Oversees planning and execution of major submissions and responses to regulatory authorities related to INDs, amendments, aggregate reports, NDAs and supplements within company timelines and in accordance with regulations and guidelines.
Determines innovative and sound strategies in support of submission goals.
Interacts and manages internal/external functional business units effectively to gather data and develop documentation required for on-time submissions.
Ensures submission documents are accurate, compliant, and high-quality to allow for smooth and rapid approvals from regulatory authorities.
Accountable for ensuring GRA senior management is aligned with strategy, timelines, risks, and mitigations with the goal of presenting a unified regulatory position.
Interprets and communicates HA correspondence effectively and quickly to GRA Sr. Management, senior leadership, and project teams.
Develops strategies and lead the response process to HA requests.
Works closely with the Global Regulatory department to lead departmental initiatives to improve overall efficiency, quality, and/or output.
Oversees and evaluates performance of assigned Regulatory Affairs Managers and/or Associates (permanent/contractor).
Reviews and establishes Standard Operating Procedures and RA processes as needed, including strategic implementation of electronic regulatory submissions processes and systems.
PhD/MS/DVM/MD/BS in life sciences, scientific, or engineering field.
7+ years of relevant experience in pharmaceutical R&D industry and/or regulatory affairs.
Hands-on experience in gaining regulatory approval on at least one major marketing application (NDA/BLA/MAA/JNDA etc. or major supplemental application) or strategic lead experience with late stage/marketed products/ life-cycle management.
Regulatory lead experience in US.
At least 2-3 years of experience managing internal staff and/or external consultants.
Knowledge, Skills and Other experience
Strong oral and written communication skills.
In-depth working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, EMA, Health Canada, PMDA, etc.
Direct interactions/meetings/negotiations with FDA and/or other regulatory authorities.
Able to successfully interpret and apply regulatory intelligence to work output.
Strong critical thinker with ability to work with uncertainties, analyze problems, and recommend innovative solutions.
Proactively manages and communicates issues, scopes, progress and risks throughout the project lifecycle ensuring key stakeholders are informed.
Results-oriented, entrepreneurial and self-motivated with excellent organizational skills.
Able to prioritize and work well in a fast-paced environment to multi-task, problem solve, and motivate and lead others.
Able to establish close communications and working relationship with cross functional teams to meet business objectives.
Able to present to senior leadership clearly, succinctly, with open-mindedness and willingness to defend difficult positions
Strong demonstrated experience with Microsoft Office programs (Word, Excel, Powerpoint, Outlook) and familiar electronic document management systems (EDMS).
Strong sensitivity for a multicultural and multinational environment.
Provide creative and innovative ideas to move the Global Regulatory department to address current and future challenges.
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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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is an innovative, fast-growing healthcare company that discovers and develops new compounds that address unanswered medical needs and advance human health. With a strong focus on neuroscience, oncology, and cardio-renal treatments, OPDC is dedicated to improving the health and quality of human life. For more information, visit www.otsuka-us.com.
OPDC is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en/.