Regulatory Affairs Manager EU
Regulatory Affairs Manager EU
Anneessensstraat 3-5 bus 9 Antwerpen Belgium
Regulatory Affairs with more than 2 years of experience
PhaRA is a leading consultancy firm in EU Regulatory Affairs located in the Benelux. Focusing exclusively on regulatory affairs, PhaRA offers in-depth expertise and skills covering a broad range of RA activities throughout product development and life cycle for chemical entities and biologicals. PhaRA is the content provider of Clarivate’s Belgian RA related documents. Established in 2002, our renowned PhaRA team has an impressive track record of successful registrations and projects. Our consultants highly value the broad range of roles and projects they can take on, as well as the variable client settings in which they can operate. Talent development and know-how sharing is at the heart of our strategy, acknowledging needs for personal flexibility and ambitions. For more information, visit www.phara.eu.
We are seeking to strengthen our team with an enthusiastic, motivated, hands-on Regulatory Affairs Manager.
You support regulatory projects at EU level, either in early phase, (pre)filing and/or during life cycle management.
You act as a regulatory scientific writer for several parts of dossiers, such as clinical trial applications, briefing books for scientific advice, pediatric plans, orphan drug designations that will be submitted to the regulatory authorities.
·You provide input to client teams on regulatory procedures and documentation requirements for regulatory applications and response strategies.
·You plan, prepare and submit clinical trial applications for development projects or post-authorisation applications (variations, renewals, etc.) and adequately handle responses to questions from health authorities.
·You plan and track regulatory activities in a reliable way.
In a nutshell, you develop your RA experience with the support and mentoring of senior colleagues, live your passion in RA and strive to become an RA expert. That way, you eventually fulfil the unmet need of patients.
Master in (pharmaceutical) sciences or PhD with a few years of industry experience in Regulatory Affairs in a pharma or biotech environment. Your strengths and mindset:
Accuracy is your second nature.
A highly motivated, dynamic person and team player who can operate in a flexible and often virtual working environment.
Clear and effective written and oral communication skills (English and Dutch).
Analytical and problem-solving skills.
Customer-minded and quality output driven.
A pleasant personality with effective interpersonal skills.
Experience in one of our spearhead domains (infectious diseases, oncology, immunology, vaccines) is a plus.
You are part of a young, diverse and unique team with an informal culture where expertise sharing is paramount.
A competitive salary and extra benefits.
A varied job where you can take on different kind of projects in a broad range of therapeutic areas and procedures (national, MRP/DCP, CP).
A clear commitment to invest in expanding your knowledge and personal growth.
The PhaRA office is located in Antwerp, Belgium. Excellent accessibility by public transport (literally 5 minutes’ walk from Antwerp Central Station).
To us, working from home was common before covid-19 and we are fully equipped to continue to do so. We nevertheless believe in the benefits of real-life contact and face-to-face knowledge-sharing, learning and mentoring. Of course, respecting all necessary precautions and government instructions comes first.
Normally, your job requires regular commutes to clients and/or partially working from a client’s premise.