VP Regulatory & Clinical Affairs

Purpose and scope of the role

The VP, Regulatory & Clinical Affairs at Biocartis leads and manages the global regulatory and clinical affairs teams to align with company goals and ensure operational excellence. This role combines strategic development, operational leadership, and financial management to support business objectives. 

Key responsibilities include integrating best practices, providing expert clinical strategy, regulatory strategy and advice, and ensuring effective collaboration with business teams. The role involves talent development, resource optimization, and coaching to build high-performing teams. The VP, Regulatory & Clinical Affairs serves as a change agent, demonstrating leadership to achieve both immediate and long-term goals. 

As part of joint accountability for Regulatory Compliance with the Head of Regulatory, Clinical/Medical and Quality Affairs, this role is responsible for ensuring completion of technical documentation, fulfilling global reporting obligations, and reviewing and providing input to regulatory submissions.

The position requires participation in cross-functional meetings, adherence to the organizational reporting line, and occasional international and US travel for conferences or customer meetings. Onsite presence in Mechelen every 2-3 months would be expected or as required by business needs.

Accountabilities

Leadership and Management:

• Accountable for leading the clinical and regulatory affairs teams, establishing resource and competence plans in line with company strategy, product roadmap, objectives, and budget.
• Ensure best-in-class performance of clinical and regulatory affairs, empowering team members to represent their areas within projects.
• Manage, oversee, and balance resource allocation, ensuring availability of human resources according to short-, mid-, and long-term business demands.
• Lead all operational aspects of the functions while continuously striving for performance improvement and effectiveness.
• Operate as the process owner of efficient and effective business processes for the respective functional teams.
• Cascading company objectives within the respective teams.
• Ensuring appropriate reporting and/or escalation to the required governance bodies.
• Serve as an inspirational coach and mentor for the team, encouraging job satisfaction, personal growth, and professionalism.

Strategic Development:

• Contribute to the development of clinical and regulatory affairs strategies to serve short-, mid-, and long-term business needs, and the implementation thereof.
• Liaise with project and functional leads to deliver competence and capacity according to business demand and budget.
• Ensure streamlined interfaces (e.g., processes) between clinical, regulatory affairs, and other functional areas.
• Maintain regulatory and clinical affairs competence management and succession planning in line with team and business needs.
• Act as a change agent, leading organizational or departmental change processes when necessary. Drive the transformation of clinical and regulatory operations through best practices, digital tools, and lean processes. Act as a change agent, promoting continuous improvement and organizational resilience
• Identify, assess, and mitigate regulatory and clinical risks that could impact business outcomes. while developing creative solutions to navigate and adapt to an evolving regulatory and clinical landscape.

Financial Accountability:

• Accountability for financial monitoring and budget management of the respective functional teams.
• Ensure effective budget management for regulatory submissions, registrations, clinical validation activities, and on-market surveillance.

Compliance and Regulatory Oversight:

• Ensure state-of-the-art clinical and regulatory affairs processes meeting the different business area needs.
• Oversee domestic and international submissions and registrations within budget and compliance, including FDA 510(k)/De Novo/PMA and EU IVDR compliance.
• Ensure appropriate communications with FDA and other regulatory authorities.
• Ensure effective on-market surveillance and vigilance.

Clinical Affairs:

• Design and oversee clinical studies, including pre-market clinical trials and post-market surveillance, ensuring scientific rigor and regulatory compliance.
• Develop evidence generation plans that support market access and product differentiation.

Team Building and Development:

• Develop high-functioning teams with a clear vision of needed competencies, knowledge of employee retention, remote teams, and succession planning.
• Create a context that stimulates initiative and continuous improvement for team members within the highly regulated and fast-moving business context.
• Ensure optimal project assignment and competency management for the clinical and regulatory affairs teams.

Collaboration and Communication:

• Support strategic management of multiple international submissions and registrations, ensuring effective communication and submission management directly and through Distributors, CROs, and Local Representatives.
• Work with Clinical Affairs to create clinical validation strategies to meet expectations of regulatory authorities, including US FDA and IVDR.
• Provide advice and input regarding new CDx and partnering opportunities, ensuring regulatory and clinical input is considered in managing expectations on timelines and commitments to external parties.
• Support the writing and compilation of regulatory submissions, including Pre-submission documents, IDE applications, 510(k) and De Novo submissions, pre-market applications, and post-market reporting.
• Conduct regulatory intelligence/research to assist in formulation of strategic decisions.
• Own the Gatekeeping process, assigning principal Regulatory Gatekeeper and backup, and work with Sales and Marketing teams to ensure marketing materials conform to regulatory requirements.
• Represent Regulatory Affairs in audits/internal audits and inspections.

• Ability to clearly, accurately, thoroughly, and compellingly communicate important regulatory and clinical details to diverse audiences.

Profile requirements

• Education: Minimum of a bachelor’s degree in a medical, pharmacy, scientific, clinical, or regulatory discipline with relevant industry experience.

• Experience:

  · Minimum 10 years of combined international experience in IVD Clinical and Regulatory Affairs is required.

  · Proven success in design and execution of clinical studies, preferably in oncology/CDx and regulatory submissions resulting in device clearances/approvals.

  · Proven track record of progressive leadership in clinical and regulatory roles, including at least 5 years in a senior leadership capacity.

  · Demonstrated remote leadership success, with a track record of managing international teams and complex projects across time zones.

  · Proven ability to lead change initiatives and streamline operations.

  · Extensive knowledge of Design Control for IVD.

  · In-depth knowledge of IVD regulations (experience with FDA PMA submissions is strongly preferred).

• Technical/Theoretical Knowledge, Skills, and Expertise:

  · Working knowledge of molecular diagnostics.

  · Strong working knowledge of ICH and GCP guidelines.

  · Applied understanding of regulations and the application of ISO 13485 and 21CFR820.

  · Solid understanding of QMS and GMP expectations.

  · Solid understanding of standards and guidelines (e.g., ISO14971, CLSI, EP7, etc.).

  ·  Solid understanding of Clinical (Design) validation expectations.

  · Excellent technical writing and good documentation skills.

  · Applied knowledge of MS Office (Outlook, Excel, Word, PowerPoint).

  · Demonstrated business acumen with a thorough understanding of the budgeting process and of P&L.

  · Strong presentation and business writing skills.

  · Well-developed negotiation skills.

  · Excellent communication and stakeholder management skills.

  · Thrives in a fast-paced and changing environment.

• Legislation and Regulation

  · Maintaining up to date knowledge of policies and legislation regarding regulatory guidance and understanding business implications.

Interested in this career opportunity ?

Please send your CV and motivation letter to : [email protected]