(Sr.) Consultant Regulatory Affairs

Company Profile

3D-PharmXchange is a drug development consultancy company located in Tilburg, Oss and Amsterdam. We are passionate about delivering strategic and operational support to clients, with a strong commitment to problem-solving and long-lasting relationships. Our team of experts cover the key areas in drug development of non-clinical, clinical, CMC and regulatory affairs. In addition, we provide project leadership and interim management support. Our clients are leading big pharma companies as well as innovative biotech start-ups and academia. Our mission is to provide true patient-centered smart expert guidance to support the development of safe and efficacious drugs at the highest quality, highest efficiency and lowest costs.

Job description

Join our dynamic and experienced team as a (Senior) Regulatory Affairs Consultant, where you’ll play a hands-on role in developing life-changing therapies and delivering meaningful impact for our clients. This role includes various projects we run for our clients varying from regulatory strategies for the drug development (clinical) programs, agency interactions to regulatory affairs project management. The ideal candidate is able to look beyond their borders and has an ambition to grow professionally within a dynamic and expanding organization.

Minimal requirements

• Master’s degree/PhD in Life Sciences, e.g. Biomedical Sciences, Medical Biology, Pharmacy, Chemistry
• At least 4 – 8 years of experience in regulatory affairs in the pharmaceutical industry
• Communication skills: good oral, writing and presentation skills
• Personality skills: pro-active, team player, entrepreneurial, can work under time pressure, can-do mentality and ability to put yourself in the position of our clients.

Experience in a number of the following areas and roles (not all required):

• In-depth knowledge of global regulatory requirements for the development and registration of new human medicinal products (chemical entities, biologicals and/or ATMPs)
• Direct experience in preparing regulatory strategies from early-stage development up to marketing authorization
• Proficient in preparation and submission of scientific advice, orphan designation applications and pediatric investigational plans (PIPs) to EMA, FDA and/or national competent authorities
• Interactions and meetings with regulatory agencies
• Proven experience in writing and/or reviewing documents for specific global regulatory purposes, e.g. investigators’ brochures, nonclinical and clinical dossier (eCTD) overviews/summaries, scientific advice briefing/background packages, target product profiles, risk management plans (RMPs), agency response documents, etc.
• Preparation and submission of clinical trial applications
• Experience in companion diagnostic regulations
• Project management/coordination and project team participation

Our offer:

• Be part of a dynamic group of experienced drug development experts
• Enjoy a company culture that prioritizes work/life balance
• Flexible remote working options
• Competitive salary along with a bonus plan
• Excellent secondary benefits, including pension
• Engage in diverse projects and work with a wide range of clients
• Work alongside with a team of friendly and supportive colleagues

Interested?

Contact Us

Please attach your CV and short motivation letter to our contact form! For more information, you can also contact us at +31 (0)135348272.