Senior Regulatory Submission Manager

Location : United Kingdom

Duration : 6 months Fixed term

POSITION OVERVIEW:

Regulatory Submission Management (RSM) acts as a partner for strategic planning and execution of the portfolio, to ensure global Regulatory submissions are scalable, seamless, and optimized. We are a trusted companion across Regulatory Affairs, bridging strategy and execution while building knowledge across the portfolio to bring therapies to patients faster, together.

You will, manage the execution of complex global regulatory submissions, and lead review and planning processes for multiple products, or projects. You will work with stakeholders to establish timelines and coordinate activities. You will represent RSM on relevant product, project, and/or regulatory submissions teams, providing specialist guidance on technical regulatory requirements and timing. You may also represent RSM on other cross-functional initiatives and act as a sub-capability lead or SME within RSM. You will plan and have oversight for assigned products and may serve as the RSM lead for global and complex submissions. You will lead development of process improvements, new standards, and updating systems in support of submissions. You will coach, train, and provide guidance to less experienced colleagues.

Essential Duties and Job Functions:

• Plans and oversees their assigned products or programs with responsibilities including development and management of global and regional content plans and resource planning for assigned submissions.
• Acts as a technical and operational lead who is knowledgeable of regulatory submission requirements specific to key regions such as the US, EU, ACE. Have a general awareness of current and global health authority requirements and trends to assess the impact on efficient global reuse strategies.
• Plans and conducts regulatory submission team meetings. Anticipates obstacles and develop solutions within the team.
• Negotiation and conflict resolution skills.
• In relation to regulatory submissions, may coordinate, track, and prepare project information and activities, including minutes, timelines, action items and function-specific deliverables. Ensures integration of project timing, scope and resources.
• Represents RSM in cross-functional teams, such as product, project and/or regulatory submissions teams; providing guidance for optimal technical strategies to achieve speed-to-filing or meet technical health authority requirements; may act as a technical and operational lead for submission execution.
• May act as a Sub-Lead or Subject Matter Expert for various expertise related to RSM Core Capabilities.
• May support the planning and preparation activities of regulatory deliverables with direction from an RA Liaison and/or GRAD Affiliate
• Organizes preparation of high-quality documents for internal stakeholders. Author documents and/or procedures for submissions such as cover letters, forms and other documents as assigned.
• Leads development/improvement of submission standards, submission templates, and validation decision trees.
• Act as the primary interface with the publishing team to plan and negotiate publishing timelines and deliverables.
• Where applicable, oversees the work of external contractors supporting deliverables and other activities.
• Coaches, trains, and provides guidance to less experienced Submission Management colleagues.
• Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.
• Leads the development/evolution of the regulatory submission intelligence framework and operating model, evaluating emerging technologies and industry trends, including leading pilots and initiatives that advance future-state capabilities

Minimum Education &​ Experience:

• BA/ BS with 8+ relevant submission management, regulatory project management or regulatory operations experience in the biopharma industry, or 6+ years’ relevant experience with MA/MS/MBA, or 3 years’ relevant experience with PharmD/PhD.
• Experience managing complex submissions across multiple stages of drug development and across multiple regions.
• Experience working with one or more TAs and varying stages of drug development is strongly preferred.

Knowledge &​ Other Requirements:

• Recognized as a SME in a broad range of regulatory submission types and a resource for technical advice and guidance.
• Demonstrated experience developing, executing, and maintaining regulatory submission content plans, coordinating cross-functional stakeholders, and managing submission content plans in Veeva (preferred).
• Able to advise cross-functional partners on technical health authority requirements and RSM processes to meet business goals and objectives.
• In-depth knowledge of relevant health authorities, including system, processes and regulatory spec requirements.
• Demonstrated ability to independently take on and execute multiple complex tasks.
• Ability to take accountability and empower individuals and teams to make effective decisions which are aligned with the company’s vision, values and goals.
• In-depth knowledge of regulatory document technical requirements and guidelines relevant to assigned products, projects, and markets
• Knowledge of full cycle submission management and has shown ability to effectively apply this knowledge to achieve targeted submission outcomes.
• Knowledge of submission management best practices and tools and has shown ability to apply these to improve submission efficiencies and effectiveness.
• Knowledge of the evolving regulatory intelligence landscape, including industry initiatives, data and AI-driven regulatory innovations, eCTD standards, and emerging health authority requirements. Practical Regulatory Intelligence experience required. Candidates should have direct experience gathering, analyzing, and applying regulatory intelligence to business processes, regulatory strategy, or submission planning, beyond general knowledge of regulations and compliance requirements.
• Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, Smartsheet and Sharepoint as evidenced through accomplishments in past roles.
• Ability to lead and influence submissions, projects and/or initiatives.
• Strong interpersonal skills and understanding of team dynamics.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
• Proven ability to lead successfully in a team-oriented, highly matrixed environment.
• When needed, ability to travel.