Regulatory Affairs Officer

Job description

The Regulatory Affairs Officer reports to the Associate Director, Regulatory Affairs Strategy and interacts with the Global Strategic Implementation team, Regulatory Affairs counterparts cross franchise, Manufacturers, Clinical Operations Departments, local regulatory affiliates, quality department, technical department, finance and human resources. 

Responsibilities
  • Assists with organizational tasks for the Regulatory Affairs Global Strategic Implementation Department
  • Responsible for the maintenance of regulatory databases, trackers and systems
  • Assists with preparing the necessary documents, outlines and application forms for initial clinical study regulatory submissions, amendments, and closure of study packages in compliance with country regulatory requirements
  • Prepares Departmental meetings and audits (logistics, formatting)
  • Ensures payment administration
  • Coordination of training into the Learning Management System
  • Acts as Records Management Coordinator, ensuring record retention policy and procedures are implemented
  • Creates and approves ECOs  pertaining to the Coordinator’s projects and duties (including but not limited to SOPs)
  • Fulfills products release requests in accordance with Regulatory requirements
  • Fulfills Late Stage Customization (LSC) preparation, update, implementation of the Product Artwork Relationship Matrix (PARM)
  • Provides operational support for affiliates requests
  • Provides operational support for economic operator and supply chain initiatives, including but not limited to those for European Authorized Representative
  • Assists in the development of best practices for Regulatory Affairs processes
  • Provides solutions to a variety of problems of limited scope and complexity
  • Responsible for communicating business related issues or opportunities to next management level
  • For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Performs other duties assigned as needed
Profile
  • 4-6 years of work experience, preferably but not limited to regulatory affairs
  • Bachelor diploma
  • Excellent written and verbal communication skills in English
  • Creative and good computer skills: Outlook, Power Point, One Note, Excel,
  • Detail oriented, conscientious,
  • Ability to take on diverse tasks,
  • Good organizational skills
  • Capacity to work in and with a diverse team
  • Belgian residence
Our offer
  • An attractive salary in line with your experience and skills.
  • Fringe benefits including a medical insurance, pension plan and a care plan.
  • A supporting environment.
  • Respect for the life-work balance.
  • Career planning.
  • A focus on professional and personal growth through training and coaching.
  • Room for personal engagement to help shape our company's future.
Location
Diegem
Contact person

Rafael Hoebrechts

Personal profile
Attachments
PDF, DOC, DOCKX (5MB)
Contact details
Tim
Janssen
Managing Partner

Do you want to learn more about Fern Valley? Are you interested in seeing how we can help your company grow? Let's get acquainted. I'll be delighted to hear your story and to share our vision. Experience the personal & open approach of Fern Valley and embark on a journey with us.

+32 487 10 61 46
tim.janssen@fern-valley.com