Senior Regulatory Affairs Leader - North America

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotechcompany with offices in Europe in Belgium, the Netherlands, France and in US.

Galapagos' mission is to make a lasting positive contribution to society through discovery of innovative therapies for diseases with large unmet medical need. Galapagos seeks to develop a robust portfolio of therapies that have the potential to revolutionize existing treatment paradigms. The company's ambition is to become a leading global biopharmaceutical company, focused on the discovery, development and commercialization of innovative medicines to improve patients' lives.

Galapagos is now entering an exciting new chapter to expand and diversify its pipeline for the future, starting with oncology, specifically CAR-Tcell-therapy, a transformative treatment of different types of cancer. Through the combined acquisitions of CellPoint and AboundBio, we are propelling ourselves into next-generation cell therapies. CellPoint brings a novel, decentralized point-of-care cell therapy manufacturing model, which has the potential to offer efficient, 7-day time to treatment and avoids complex logistics, resulting in potential better patient outcomes and broader access. AboundBio's cutting-edge fully human antibody-based platform provides access to a research engine for next generation multi-targeting CAR-Ts that have the potential to deliver deeper and durable clinical responses and that will be developed using CellPoint's decentralized model.

We are looking for aSenior Regulatory Affairs Leader - North America

Scope of the job:

The Senior Regulatory Affairs LeaderNorth America (NA) will be responsible for providing NA regulatory leadership and direction in support of the development, registration, and life-cycle management of innovative programs (focus = clinical/nonclinical strategy). The responsibilities include developing regulatory strategies and detailed plans to ensure successful achievement of company objectives, participating in program core teams and governance forums, and managing regulatory agency interactions in support of development and registration strategies.

The individual will develop the required regulatory capabilities in the US office and will provide oversight of the content and preparation of all regulatory documents/submissions related to applicable programs and mentor junior members of the regulatory team. The individual must possess a thorough knowledge of global rules, regulations, and guidelines governing drugs and biologics in all phases of development. This position will report to the Head Regulatory Affairs (located in Europe).

Your role

• Obtain and maintain regulatory approvals for Galapagos' products.
• Act as primary company liaison with the NA Health Authorities.
• Represent Regulatory Affairs on the assigned cross functional Project Team(s) and Governance forums.
• Within the context of the global strategy, drive the development of sound NA regulatory strategies for regulatory applications including NDA/BLA, IND, meeting packages, special protocol assessments (SPA), and special designations (e.g. fast-track, orphan drug, breakthrough, RMAT). Set challenging, but achievable regulatory objectives/plans, striving for accelerated development timelines in accordance with the company business goals.
• Lead and/or participate in meetings with NA Health Authorities, as appropriate.
• Actively participate in the creation and senior leadership review of key development documents and meeting packages.
• Manage and develop the NA external vendor network and relationships required to deliver regulatory documents and dossiers of high quality. Oversee NA Regulatory operations in close collaboration with the Global Regulatory Operations team. Ensure adequate tracking, archiving and records clean-out activities for assigned projects.
• Keep abreast of developments in NA Regulatory Affairs and drug development strategies and requirements; inform and advise the internal organization. Define, initiate, and lead input initiatives to calls for comments, especially in those areas where impact needs to be made to help achieve the company-wide efforts/business goals.
• Develop the regulatory capabilities in the US office. Act as leader by mentoring, coaching, and developing people to fulfil their potential, while also delivering business objectives.
• Ensure full compliance with all applicable regulatory and legal requirements and ensure alignment in the company processes.
• Adherence to existing Galapagos Policies and Procedures and timely completion of relevant training.

Working Relationships:

Head Regulatory Affairs (line manager)

Members of Regulatory Affairs department (direct colleagues, complementary role)

Project Leaders, Product Development Team and Clinical Development Team members (peers in PT and CDT)

Who are you?

University degree in health sciences, pharmacy, biological science, chemistry or related field.

At minimum 15-20 years of in-depth clinical-regulatory drug development experience in the US in the pharmaceutical/biotech industry and/or with FDA, with a clinical/nonclinical-regulatory background in oncology with specialism in the CAR-T or cell/gene therapy. A profound and demonstrated knowledge of the international Regulatory Affairs environment with a sound understanding of the pharmaceutical/biotech business environment will be required as well.

A profound and demonstrated knowledge of the international Regulatory Affairs environment with a sound understanding of the pharmaceutical/biotech business environment.

Attitude of reliability and attention to detail.

Strong organization skills, a high degree of flexibility, resilience, and assertiveness are essential for success.

Professional attitude towards external and internal contacts. Effective communication style and interpersonal behaviour.

Proven mature people management and coaching skills.

Able to work efficiently in a x-functional matrix organisation.

ln addition, data gathering, problem solving, and analytical thinking skills are highly desirable.

Strong verbal and written communicator in English language, multilingual is an asset.

This will be the first regulatory position for Galapagos in the US. We are specifically looking for a well-organized self-starter senior profile. Our NA activities are located in the Princeton area (US). With global operations being located in Mechelen (BE), Leiden (NL) and Basel (CH), candidates for this position would be willing to travel to Europe a few weeks per year.

What's in it for you?

You will be part of a fast growing and amazing company. As 'make-it-happener' you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos' leading position and achieve breakthroughs in biopharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.

We are Galapagos: together we can make it happen...!