Senior Manager, CTA Regulatory Strategy - Remote

Otsuka Pharmaceutical Co., Ltd; United Kingdom; Remote; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Senior Manager for CTA Regulatory Strategy to lead global regulatory efforts for clinical trial applications. This role involves collaborating with cross-functional teams to ensure timely submissions and compliance with EU and UK regulations. The ideal candidate will bring over seven years of regulatory strategy experience, strong communication skills, and a proven ability to navigate complex regulatory landscapes. Join this innovative firm and contribute to impactful projects that shape the future of healthcare while enjoying a comprehensive benefits package and a supportive work environment.

Benefits

Comprehensive medical coverage

Dental insurance

Vision coverage

Tuition reimbursement

401(k) match

Flexible time off

Paid holidays

Paid leave programs

Qualifications

• 7+ years of regulatory strategy experience in global pharmaceutical development.
• Expertise in Clinical Trial Applications for EU and UK regulations.

Responsibilities

• Lead regulatory strategy for Clinical Trial Applications and manage lifecycle activities.
• Collaborate with global teams to address regulatory issues and health authority queries.

Skills

Regulatory Strategy

Communication Skills

Document Management Systems

Problem Solving

Project Management

Clinical Trial Applications

Negotiation Skills

Staff Management

Education

Bachelor's Degree

Certification in Regulatory Affairs

Tools

Microsoft Office Suite

Documentum

SharePoint

Job description

Senior Manager, CTA Regulatory Strategy - Remote

Senior Manager, CTA Regulatory Strategy - Remote

Apply locations Remote time type Full time posted on Posted 7 Days Ago job requisition id R8973

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.

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.