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RA Professional (Benelux) - Belgium
Posted on : 16 November 2016
We are a consultancy firm in EU regulatory affairs, located in Antwerp. We provide strategic and hands-on regulatory support in various therapeutic areas ranging from life-threatening diseases to OTC and borderline products. We are looking for a Regulatory Affairs Professional with 3-6 years of experience in Benelux regulatory affairs to join our team.
Your main focus will be regulatory activities at Benelux level.
Depending on your level of experience, you will, for our clients:
- Manage or support a product portfolio and interact with national competent authorities on regulatory submissions in Benelux countries.
- Support the European regulatory affairs groups with local regulatory intelligence information and contribute as appropriate to the regulatory strategies.
- Interact with colleagues from European headquarters at client companies with regard to the collection of information necessary for submissions and to address questions from competent authorities.
- Be responsible for, or assist with, the preparation, submission and follow-up of marketing authorization applications and variation files, in line with national Benelux regulatory requirements, scientific principles, and company policies and procedures.
- Assess material for publicity and information purposes and compliance of scientific/commercial events in the Benelux territories.
- Contribute to the maintenance of quality systems and SOP writing.
- Master in Pharmaceutical Sciences or equivalent with minimum 3 years of experience in Benelux regulatory affairs.
- Experience with review and approval of publicity and medical information is an asset.
- Proficient oral and written Dutch, French and English language skills; German is a plus.
- Ability to foster relationships with internal and external stakeholders (such as RA colleagues, medical affairs, commercial, market access, pharmacovigilance, and competent authorities).
- Diligent to work in compliance with regulatory legislation and Quality Assurance systems.
- Ability to adapt to different client company cultures and service minded attitude.
- Accurate, proactive, reliable, hands-on, and quality output driven.
- Maintain product portfolio overview, proven ability to meet deadlines and set priorities.
- Positive and pleasant personality with effective interpersonal skills.
- A competitive salary.
- Varied job in a young and dynamic environment.
- Continuous learning and exchange of expertise with seasoned regulatory affairs colleagues.