Director, Regulatory Affairs EU

Viking Therapeutics, Inc.•South, KY

just now•Hybrid

About The Position

The Director, Regulatory Affairs — Europe (the “EU RA Lead”) will own the Company’s European regulatory strategy and execution and will lead the Marketing Authorization Application (MAA) for SC VK2735 under the centralized procedure, followed by the corresponding application for oral VK2735. The role carries end-to-end responsibility for the MAA: eligibility and Rapporteur engagement, pre-submission activity, dossier assembly and validation, management of the assessment clock and responses to CHMP questions, oral explanation preparation, labelling negotiation through CHMP opinion and European Commission decision, and pricing and reimbursement. The role also owns the United Kingdom strategy and submission to the MHRA and interactions with the HPRA in Ireland. The Vice President of Regulatory Affairs retains overall accountability for global, program-level regulatory strategy. Within that framework, the EU RA Lead holds decision authority for European regulatory positions and is expected to execute the resulting work directly. This is a working role within a lean, virtual-sponsor operating model: the successful candidate will be comfortable authoring and quality-controlling submission content personally while simultaneously directing consultants and vendors.

Requirements

Bachelor’s degree in a scientific discipline required; advanced degree (MSc, PhD, PharmD, or equivalent) preferred.
Director: minimum of 10 years of pharmaceutical or biotechnology industry experience, including at least 8 years in Regulatory Affairs with a substantial European focus. Senior Director: minimum of 13 years of industry experience, including at least 10 years in Regulatory Affairs. An advanced degree may substitute for up to two years of experience.
Demonstrated hands-on experience on at least one MAA submitted through the centralized procedure. For appointment at Senior Director, the candidate will have led an MAA through the assessment procedure to CHMP opinion; for Director, substantive core-team contribution across the procedure is required.
Experience with the UK regulatory framework following EU exit, including MHRA national procedures and the International Recognition Procedure, and awareness of Northern Ireland supply requirements.
Legally authorized to work in Ireland without Company sponsorship, or eligible for an employment permit.

Nice To Haves

Experience in metabolic, endocrine, or cardiometabolic therapeutic areas, or with peptide therapeutics, is preferred.
Drug-device combination product experience, including autoinjector or pen presentations, notified body interactions, and the interfaces with human factors engineering and design control, is preferred.
Ability to operate effectively as the sole European regulatory presence within a U.S.-headquartered organization.
Strong analytical, interpersonal, and well-developed problem-solving skills with the ability to work in a positive and collaborative fashion.
Ability to contribute substantively to regulatory strategy discussions and to articulate a supported position clearly and concisely to management and to health authorities.
Team player with excellent written and verbal communication skills in English; additional European language capability is a plus but not required.

Responsibilities

Own European regulatory strategy for SC VK2735 and oral VK2735, translating a U.S.-led development program into a filing plan that satisfies EU requirements.
Lead the MAA for SC VK2735 under the centralized procedure, including eligibility confirmation, Rapporteur and Co-Rapporteur appointment and engagement, pre-submission meeting(s) with EMA, letter of intent and submission date confirmation, and preparation of the application in EU eCTD format with a compliant Module 1.
Plan and lead EMA Scientific Advice and Protocol Assistance procedures, national competent authority advice.
Manage the notified body opinion for the SC VK2735 autoinjector, required for integral drug-device combinations; treat the notified body engagement as a critical-path item for MAA submission and manage the device documentation package accordingly.
Lead United Kingdom regulatory strategy and submission to the MHRA, including selection among available national routes such as the International Recognition Procedure and other MHRA designations, and UK QPPV and Responsible Person requirements.
Represent Regulatory on cross-functional teams and provide the European regulatory position on clinical, nonclinical, and CMC matters; contribute EU-specific content requirements to the Common Technical Document, including Module 1 regional documents and EU-specific Module 2 elements.
Perform detailed review and quality control of submission documents prior to release for publishing, assessing scientific accuracy, internal consistency across documents, regulatory compliance, and correctness of cross-references and citations to European legislation and guidance.
Support inspection readiness across the Company and its contracted CROs and CMOs, including EU and UK GCP and GMP inspection preparation and pre-authorization inspection support in a fully outsourced operating model.
Serve as the primary European interface to the U.S. regulatory team, maintaining a single source of truth for submission content, health authority correspondence, commitments, and agreements across regions and support the US NDA activities as needed.
Identify and escalate regulatory risks and issues to the Vice President of Regulatory Affairs with supporting analysis, available options, and proposed mitigations, distinguishing clearly between what legislation requires, what guidance recommends, and what remains unsettled.
Other duties as assigned.