Senior Regulatory Affairs Leader - North America

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe and in the US.

We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happener’.

We are looking for a Senior Regulatory Affairs Leader - North America. 

Scope of the job

As Senior Regulatory Affairs Leader North America (NA), you 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.

You 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. You must possess a thorough knowledge of global rules, regulations, and guidelines governing drugs and biologics in all phases of development. In this position, you 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.
• 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 behavior.
• Proven mature people management and coaching skills.
• Able to work efficiently in a x-functional matrix organization.
• 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…!