Senior Regulatory Affairs Leader (EU) (more than 10 years of experience)

Job Description

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 10 years of experience in procedural, scientific and strategic aspects of regulatory affairs with a focus on the EU.

While being exposed to both major pharmaceutical companies and biotech SMEs, you will work in an informal and dynamic organization with less complex governance. Together with PhaRA colleagues and client teams, you can build on your extensive scientific and EU RA experience and live your passion in RA at an expert level, eventually fulfilling the unmet need of patient.

Embedded in and supported by our team, you will support our clients for 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 client project teams in an international environment, and coach more junior staff at clients or within PhaRA.

Profile

  • Master with preferably a PhD in a scientific discipline relevant to the development and life cycle management of medicinal products.
  • At least 10 years of experience in scientific and EU procedural RA for medicinal product development and/or life cycle management. Past experience gained at large to mid-size pharmaceutical companies or consultancy firm, acting at regional EU and/or global level and developing innovative medicines 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.
  • Seasoned in developing EU regulatory strategies for early and late phase development programs for innovative drugs and biologicals. Exposure to devices/IVD or HTA is a plus.
  • Successful track record in liaising with regulatory authorities. 
  • 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 at middle management is a plus.

Your general professional competencies

  • Excellent language skills in English, Dutch. 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.
  • Pleasant personality with effective interpersonal skills.

Offer

  • A competitive salary.
  • Varied job in a young and dynamic environment.
  • Exchange of expertise with other experienced regulatory affairs colleagues, passionate by regulatory affairs.

Place of employment

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