Regulatory Operations Leader, Associate Director

Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium.

We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class medicines. With capabilities from lab to patient, including a decentralized cell therapy manufacturing platform, we are committed to challenging the status quo and delivering results for our patients, employees, and shareholders. Our goal is not just to meet current medical needs but to anticipate and shape the future of healthcare, ensuring that our innovations reach those who need them most.

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 Regulatory Operations Leader, Associate Director.

Scope of the job

The Associate Director of Regulatory Operations will oversee all Regulatory Operations functions within the Regulatory Affairs department. This role is responsible for leading regulatory submission activities, ensuring compliance with global transparency requirements, and contributing to the development and enhancement of Regulatory Operations processes and standards.

Your role

Collaborate with the regulatory team, and cross-functional team members and external contractors/vendors/consultants as needed, to support the planning, preparation, formatting, publishing, QC, submission and archiving of global regulatory submissions (i.e., INDs/CTAs/BLAs and amendments/supplements, responses to health authority requests for information, health authority briefing documents, etc).

Ensure adequate planning, tracking, and archiving of the submitted regulatory packages and associated commitments are performed in the relevant Regulatory Information Management (RIM) systems i.e., document management, publishing, submission, archiving, registration and tracking tools.

Organize, archive, and track Health Authority correspondences, submissions, and questions/commitments

Collaborate with our external publishing vendor(s) on submission publishing activities to assure on time regulatory submissions in accordance with project goals and timelines. Managing the projected regulatory submissions and assuring alignment of resources and timelines with the external publishing vendor

Work closely with the Regulatory Document Management System (RDMS) group on the management of IT systems within the scope of Regulatory Operations, such as Veeva RIM, submission publishing, CTIS, EUDAMED, and others as necessary

Be responsible for the development, implementation, and ongoing training to the organization on Regulatory Operations processes and systems, including but not limited to changes to existing processes or systems, the introduction of new processes and/or systems, and the training of new employees as necessary. In addition, be responsible for the oversight of user access management to Regulatory systems.

Partner with IT and Regulatory Document Management System (RDMS) group on the change management, release management, and ongoing validation of all Regulatory Operation computer systems

Oversee the Regulatory Operations infrastructure and development of standard operating procedures, training materials, and job aids with respect to Regulatory Affairs and Operations

Coordinate collaboration with responsible departments and oversee preparation, review, and collection of documentation for regulatory submissions

Maintain templates and style guides for regulatory submissions and providing internal regulatory document preparation technical support

Support the creation and monitoring of functional KPIs

Lead and coordinate transparency reporting and redaction processes (POL 0070, POL 0043, clinicaltrials.gov, CTIS, ...). Act as the interface with functional representatives as per procedural documents.

Adherence to existing Galapagos Policies and Procedures and timely completion of relevant training. Who are you ?

Required

BA/BS degree required

6-8+ years experience in the pharmaceutical/biotech industry, with a minimum of 5 years of Regulatory Operations and eCTD/submission publishing experience

Thorough understanding of ICH/US/EMA regulations and guidelines related to regulatory submissions and standards.

Experience with implementing / maintaining / utilizing a RIM system. Experience in Business or System Administrator is a plus

Experience with managing vendors/consultants/partners (e.g. external publishing vendor)

Strong understanding of Regulatory Operation comprehensive role Nice to have

Prior regulatory operations experience in cell and gene therapy and/or oncology is strongly preferred

Experience with BLAs/NDAs/MAAs preferred

Expertise in Veeva RIM system implementation experience a plus General skills:

Strong interpersonal and communication skills; able to build and maintain key stakeholder relationships

Works effectively both independently and as part of a team

Highly organized with excellent time management and attention to detail

Strong problem-solving and strategic thinking abilities

Demonstrates sound judgment and decision-making

Proven ability to manage multiple high-pressure, time-sensitive projects

Thrives in a fast-paced, dynamic work environment

Willing to travel domestically and internationally on occasion

What's in it for you ?

At Galapagos, we prioritize your continuous growth and development, fostering a culture of empowerment. Our employees are the driving force behind our mission to lead in pharmaceutical research and innovation.

We offer a competitive compensation package and a supportive work environment with strong focus on your health and well-being. Join us in our journey towards sustainability, as we strive to make a lasting impact on both the industry and the planet.

Galapagos is dedicated to ensuring equal employment opportunities. Our hiring decisions are based on merit, considering qualifications, skills, performance, and achievements. We strictly prohibit discrimination against any employee or job applicant based on personal characteristics that are unrelated to their job.

We are Galapagos : together we can make it happen

Base compensation for this position ranges from $135,000 to $226,000. Actual base compensation will be determined based on a variety of factors including experience, qualifications, job-related knowledge, demonstrated skills and geographic location. The company reserves the right to modify base salary ranges at any time.

In addition, this position is eligible for participation in both Galapagos' performance bonus plan and long-term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support important moments in life.