Senior Regulatory Affairs Leader
Senior Regulatory Affairs Leader
Anneessensstraat 3-5, Antwerpen, Belgium
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. 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 are at the heart of our strategy, acknowledging needs for personal flexibility and ambitions. For more information, visit www.phara.eu.
To further support our growth, we are seeking to strengthen our team with an enthusiastic, motivated, hands-on yet experienced Regulatory Affairs Leader with more than 8 years of experience in procedural, scientific and strategic aspects of regulatory affairs with a focus on the EU.
Embedded in our team, you will support our clients in the development of sound regulatory strategies, liaise with EMA and national competent authorities, lead submissions of orphan drug designations, pediatric investigation plans and scientific advice.
You may also be assigned to submission of new marketing authorization applications and the maintenance of existing marketing authorization applications and contribute to clinical trial applications and the related submission strategy. You will participate in or steer client project teams in an international environment and coach more junior staff at clients or within PhaRA.
You manage timelines to achieve registration on schedule and anticipate risks.
You report to PhaRA’s senior management team.
In a nutshell, you build on your extensive scientific and EU RA experience and live your passion in RA at an expert level. By growing and sharing your expertise with PhaRA colleagues and client teams, you eventually fulfil the unmet need of patients.
Your background :
Master or PhD with at least 8 years of experience in scientific and EU procedural RA and regulatory strategies for medicinal product development and/or life cycle management, in large to mid-size pharmaceutical companies and/or consultancy firms.
Proven successful track record in liaising directly with regulatory authorities is a must.
Strong scientific interest and background allowing to understand complex scientific data in several areas of drug development (quality, non-clinical, clinical) and frame these in a regulatory context.
Experience in specialized areas of medicinal product development such as biologicals, infectious diseases, oncology, immunology or other is a plus, as well as exposure to devices/IVD or HTA.
Excellent analytical and organizational skills and resilience to manage multiple projects and changing priorities.
Determination to deliver according to deadlines and high-quality standards.
Inspiring leadership towards external and internal clients.
Experience with company stakeholder interaction.
Your strengths and mindset :
Excellent language skills in English; Dutch and French is a plus.
Clear and effective written and oral communication skills.
Strong analytical and problem-solving skills.
Good project management skills.
Proactive and “can do” attitude.
Customer minded and quality output driven.
A highly motivated, dynamic person and team player who can operate in a flexible and often virtual working environment.
A clear commitment to stay tuned in a rapidly changing innovative environment and with the latest trends in regulatory affairs.
Pleasant personality with effective interpersonal skills.
While interacting constantly with major pharmaceutical companies and biotech SMEs, you are part of a young, diverse and dynamic team and informal culture.
A competitive salary and extra benefits
A varied job where you can take on different kinds of projects in a very broad range of therapeutic areas.
Exchange of expertise with other experienced regulatory affairs colleagues, passionate by regulatory affairs.
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 or occasional working from a client’s premise. Home-based work with regular visits to the Antwerp office is offered for candidates living outside Belgium. You can be located across Europe.