The Sr. Manager, CTA Regulatory Strategy is responsible for providing critical support in developing global regulatory strategy, planning, and execution of global investigational submissions and manages lifecycle regulatory activities for assigned Clinical Trial Application projects in alignment with the Global Regulatory Lead (GRL).
As an integral member of Otsuka's Regulatory Operations team, provides support for regulatory strategy assignments, monitoring, and oversight, as well as a lead or support of GRA efforts
Ensures assigned projects are completed with quality, on-time, and within established budgets
Work collaboratively with members of the global regulatory team (GRL, Clinical Transparency, Medical Writing, GRA-CMC, etc.) to contribute to global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations
Acts as primary liaison between Regulatory Operations and Clinical Management as well as other multiple company stakeholders to coordinate clinical trial application activities, primarily within the European Union (EU), United Kingdom (UK), and other regions as required
Engages with affiliates and collaborators to plan, submit, and gain authorization for clinical trial applications to Health Authorities
Research and apply regulatory intelligence and knowledge of strategic options to effect innovative regulatory pathways and solutions to complex global requirements and regulatory challenges.
Serves as the primary contact to Health Authorities (HA) within EU, UK, and other regions as required
Designs and implements processes and systems to maximize electronic lifecycle / maintenance submissions requirements, including a focus on continuous improvement
Collaborates with alliance partners to achieve corporate objectives for shared dossier development, submission, and archival activities
Supervises staff to assure quality control checks of deliverables intended for submission to regulatory agencies and compliance with electronic regulatory standards
Oversees project team members for assigned clinical trial application deliverables, including work assignments to vendor partners
Ensure that Regulatory Activities are performed at high quality and compliant to local regulatory requirements
Provides leadership and guidance for Process Mapping Teams (e.g., Key stakeholder for Regulatory Submissions, Key stakeholder for Clinical Trial Application Regulatory Notifications)
Develops and maintains assigned work instructions
Establishes and builds collaborative relationships with colleagues
Maintains current awareness of the EU, UK, and other applicable local regulatory requirements, updates colleagues as appropriate, and provides necessary guidance to other departments / function
Qualifications Required:
Overall knowledge of regulation/guidance in support of EU Clinical Trial Regulation (CTR) and UK The Medicines for Human Use (CTs) (Amendment) (EU Exit) Regulations 2019
Adept in professional and clear communication when interacting with regulatory authorities
Experience in global pharmaceutical development and lifecycle management including clinical development, marketing authorization application preparation and submission, regulatory support to commercialization and management of post-authorization issues
Ability to provide strategic input for key submission documents
Ability to communicate and negotiate effectively with internal/external individual organizations, especially regulatory authorities
Expert knowledge of Document Management Systems (Documentum preferred)
Strong computer skills with demonstrated experience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and SharePoint
Knowledge in developing processes across multiple departments/divisions that leverage technology
Recent experience with Clinical Trial Applications for EU and UK is essential, start-up activities is a plus
Minimum of 7 years of regulatory strategy experience and in-depth first-hand experience with application electronic submissions within CTIS and IRAS and other Health Authority portals
Preferred:
Demonstrated performance in managing and producing quality time-intensive deliverables
Strong influencing skills and experience with outsourcing
Strong staff management skills
Proven ability to solve complex issues through innovative problem solving
Well defined written and oral communication skills
Knowledge how/when to apply organizational policy or procedures to a variety of situations
Demonstrated flexibility in dealing with change and diversity
Ability to work effectively in a global, matrixed, multi-cultural, collaborative environment
Successful engagement in multiple initiatives simultaneously
Certification (such as Regulatory Affairs Professionals Society (RAPS))
Prior project management experience
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.
Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.
Minimum $146,955.00 - Maximum $210,100.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.
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.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka .
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 protec
