Do you have a first experience in Clinical Research/submissions and have an interest in extending your knowledge in the world of Regulatory Affairs in one of the biggest Biotech companies? Don't hesitate and apply today !
Hybrid opportunity at client's location in Belgium.
Job Description
The Regulatory Affairs Associate provides country regulatory expertise and execution for the development, registration, and lifecycle management of all molecules and medical devices.
The Regulatory Affairs Associate is assigned to one or more products or medical devices and may support or lead a program under the supervision of an experienced Local Regulatory Lead.
Responsibilities
- Assist in aligning local regulatory requirements with corporate standards.
- Provide national/regional (as applicable) input to and execute regulatory strategies.
- Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
- Enable regulatory agencies interactions
- Collaborates with Regional and Global Study Operations (GSO) teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements (where appropriate).
- Contributes for the clinical trials filing plan, advising and discussing with the local cross-functional team and the device regulatory team.
- With close supervision, executes the filing plan for their country(ies), where applicable.
- Ensures regulatory submissions are made on time and meet corporate and local regulatory requirements.
- Monitors changes in the local Trade Associations/national legislation and forwards information to local/regional groups communicating the impact.
- Monitors the external regulatory environment to help inform/advise in the regulatory decision making.
- Ensures/supports regulatory product compliance (e.g. agency commitments, …).
- Acts as the point of contact with regulatory agencies in fulfilling local obligations.
- Participates/contributes to local agency interactions and their preparation.
- Works closely with cross-functional colleagues in the Affiliate or Hub to align on strategy and deliver Affiliate/Hub goals.
- Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner.
- Partners with the Device regulatory team and Regional Regulatory Leads (RRLs) to support the regulatory development, registration, and lifecycle management of all molecules and medical devices.
- Partners with peers to ensure consistency on procedures.
- Acts as contact and create relationships with Agency staff with regards to assignments (if applicable).
- Assists locally in Healthcare Compliance activities where applicable.
- Participates in local regulatory process improvements, initiatives and training.
- Requirements
- Master's degree (scientific area) OR
- Bachelor's degree (scientific area) and 2 years of directly related experience.
- First experience in Clinical Research or first experience in Regulatory Affairs.
- Knowledge of Regulatory principles, specifically on IVDR is a plus.
- Experience in working in a global environment is a plus.
- Business English and native Dutch and/or French.
- Working with policies, procedures and SOP's.
- Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
- General knowledge of national legislation and regulations relating to medicinal products and medical devices.
- Understanding of drug development.
- Demonstrate ability to work in teams.
- Ability to understand and communicate scientific/clinical information.
- Existing right to work in Europe is required
Benefits
- Full-time position
- A lot of flexibility regarding homeworking (around 1 day/week, office-based).
Vacancy number: 23857
