Senior Director / Vice President of Quality, Pharmacovigilance and Regulatory Affairs

Shield Therapeutics plc is seeking a Senior Director / Vice President of Quality, Pharmacovigilance and Regulatory Affairs to provide leadership and oversight for the strategic and operational aspects of the Quality, Pharmacovigilance and Regulatory Affairs functions, with some Clinical oversight.

Role overview: The role reports to the Chief Executive Officer and leads the Quality, Pharmacovigilance and Regulatory Affairs functions to ensure compliance with applicable regulations and support the company’s product lifecycle from development through commercialization.

Job Requirements:

Quality & Regulatory

• Defining the regulatory and operational strategies to achieve full regulatory approval for products within the pipeline, as well as maintaining product registrations globally, in conjunction with partners as applicable.
• Providing advice to the Company and Board on Clinical, regulatory and Quality strategy, design and implementation.
• Maintaining oversight of the Quality Management System (QMS) to ensure compliance with GxP functions.
• Providing regulatory expertise on all clinical trial applications, marketing applications/authorisations, applications for variations, line extensions, amendments and renewals of existing clinical trial and/or marketing authorization, and responsibility for responding to requests for scientific advice from regulatory authorities.
• Communicating national and international regulatory matters to Shield Executive Team (SET) and wider Company, including identifying and communicating regulatory changes and amendments that may impact the Company.
• Leading Company discussions with regulatory agencies in the US and, as appropriate, leading or supporting partner discussions with other regulatory authorities and trade associations globally.
• Ensuring effective support and regulatory guidance throughout the product lifecycle in line with corporate strategies.
• Overseeing partner clinical, registration and life-cycle strategies and operations.
• Ensuring compliance with current regulatory requirements, monitoring guidelines and regulations, and maintaining regulatory intelligence to track competitors.
• Managing Quality, Pharmacovigilance and Regulatory Affairs teams to ensure compliance with relevant GxP regulations.

Pharmacovigilance and Clinical

• Management oversight of the global Pharmacovigilance function, as overseen by the Head of Pharmacovigilance.
• Oversight of scientific/clinical development strategy and plans for all Company assets, in conjunction with external clinical consultants and internal Medical Affairs, as appropriate.
• Represent Shield Therapeutics from a scientific perspective at meetings with medical experts and advisory panels, principal investigators, regulatory authorities, potential alliance partners and the investor community, with appropriate external and internal medical input as required.
• Ensure partner clinical programmes are conducted in accordance with Company strategy and ICH-GXP requirements.
• Ensure clinical documentation (TMFs) are stored and maintained in accordance with GCP.

Qualifications:

• In-depth knowledge of major regulatory authority regulations and understanding and usage of medical terminology
• Understanding of Quality, Pharmacovigilance, and clinical development principles and functions
• Post-graduate regulatory experience leading to a higher-level qualification such as an MD or PhD preferred
• Experience in several therapeutic areas (e.g., hematology, women’s health, GI, CKD)
• Experience leading interactions with regulatory authorities, in particular the US FDA, at key development stages (scientific advice meetings, IND meetings, end-Phase II/III meetings, advisory committees)
• Solid track record in Regulatory Affairs with clinical development experience and ability to build relationships with knowledge leaders in the US and Europe
• Significant management experience with the ability to develop and lead people
• Hands-on, self-starter, energetic, resilient and delivery-focused
• Creative problem solver with the ability to implement effective alternatives to current programmes
• Excellent team player with coordination skills across the management team
• Excellent communication abilities including presentations, leading meetings and strong writing skills
• Ability to liaise with the Board and external community with appropriate stature and experience
• Strong organisational and project management skills

Seniority level

• Executive

Employment type

• Full-time

Job function

• Strategy/Planning, Product Management, and Other
• Industries: Pharmaceutical Manufacturing

Note: This refined description removes non-essential boilerplate and unrelated postings while preserving the core responsibilities and qualifications of the role.