Regulatory Document Management & Systems Leader - Mechelen, BE - Basel, CH or Leiden, NL
Pleased to meet you, we are Galapagos, a dynamic fast-growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden), Switzerland (Basel) and US (Boston).
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 want to challenge the impossible. 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-happeners’.
We are looking for a Regulatory Document Management & Systems (RDMS) Leader
Scope of the job
The Regulatory Document Management & Systems (RDMS) Leader is responsible for understanding the document flow, processes and systems related to Regulatory Information Management Systems (RIMS). The RDMS Lead will therefore be partnering with business process owners and Information Technology (IT) to ensure accurate evaluation and documentation of all system-related upgrade activities, and to maintain the system and operational processes in a compliant state.
This position will be part of a team that enables the overall RIM business systems operations, with frequent contact with global users and support their use of RIMS. This role will serve as the business system owner for one or more applications in the RIMS and in that capacity also be the regulatory partner with IT and other business functions on delivering against the RIMS road map. The RDMS will often lead smaller projects affecting multiple disciplines, processes, and capabilities, outside of or in line with larger projects.
- Will be the owner of one or more of the RIMS applications (eDMS, Publishing, Registrations) and supports the RIMS implementation and the RIM road map.
- Coordination, development, implementation, maintenance, and compliance of RIMS and its connected / related tools, policies and processes.
- Acts as a RIMS application SME for Regulatory-IT capability related projects and activities. Typically sits in multiple works streams, providing SME guidance on RIMS and the related business processes.
- Participates in regulatory technology projects, performs analysis and design on systems projects supporting business facing activities, e.g. user requirements, User Acceptance testing, configuration, etc,
- Documents business requirements for regulatory solutions, ensuring endorsement and alignment from key stakeholders, and partners with IT to develop approach for execution and delivery
- Creates process and training documentation and make best-practice recommendations
- Supports the creation and delivery of end user training to business users to support accurate and reliable use of the RIMS.
- Supports the management of RIMS access rights based on the key Regulatory processes, roles and overall operating model allowing effective execution of key regulatory and development activities.
- Acts as a change agent, communicating the benefits of processes, tools, and systems and gaining buy-in and acceptance from the user community
- Stays current with external regulatory requirements and changes, informs and advises the internal organisation on eCTD, e-submission platforms, data gateways, reporting tools, and record retention regulatory requirements.
- Oversees submission of data and supporting documentation to external agency databases (i.e., XEVMPD) in compliance with agency requirements.
- Ensures data entry requirements and expectations are effectively communicated, monitored and resolved allowing RIMS to be the single authoritative source for accurate and up to date information.
- Collaborates with stakeholders to understand business needs for new RIMS solutions, or modifications to existing RIMS solutions.
Who are you?
- You have a Bachelor’s Degree (Information Systems or life sciences preferable) or equivalent through experience
- 5+ years of experience in Pharmaceutical, Bio-Technology, or Life Sciences, with a specific focus in Regulatory
- Working knowledge of drug development and approval process.
- 3+ years experience in Regulatory Information Management (RIM), Regulatory EDMS capabilities, or operations in a similar capability model in GxP/Regulated Systems
- Working knowledge of applicable Regulatory Agency regulations, guidelines, and specifications (e.g. FDA/EMA, ICH, eCTD, IDMP) and industry best practices pertaining to Regulatory Processes & Systems
- Submissions publishing a plus.
- Project Management skills and competencies
- Experience working with the Veeva platform preferred, but not required
- Desire to work in a fast-paced continuously changing environment.
- Able to work well with peers, partners and stakeholders with a strategic and hands-on approach
- Demonstrated attitude of reliability and attention to detail.
- Strong organization skills, a high degree of flexibility, resilience, and assertiveness are essential for success.
- Excellent planning and time management skills
- Proficiency in the required software and computer skills.
- In addition, data gathering, problem-solving and analytical thinking skills are highly desirable.
What’s in it for you?
You will be part of a 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 pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.
We are Galapagos : together we can make it happen…!