Senior Expert Regulatory Affairs Biologicals

The organization

The organisation is working on groundbreaking treatments that improve the lives of humans and animals. As a leading research-driven biopharmaceutical company, they create value through innovation in areas where the need is greatest. Such as diabetes, lung disease and cardiovascular disease. They are now looking for a Regulatory Affairs expert who would like to contribute to the development and approval of new innovative biological products.

The position

As the new Senior Expert Regulatory Affairs Biologicals, you will have four main roles:

As a RA Research Advisor, you’ll be responsible for determining the appropriate regulatory approach for a novel concept as well as identifying possible killers to avoid a late dead-end, which is especially important for new modalities like novel biotechnologies.

As a RA Project Leader or RA Product Manager, you’re in charge of defining regulatory strategies and requirements for initiatives that require expertise in the regulations of respective modalities in the EU and Primary Markets, as well as anticipating changes in the regulatory environment that may affect the project or product.

As a Mentor, you contribute to the growth of your RA mentees by sharing your knowledge and experience, helping them develop their critical thinking skills, and making the best decisions possible.

Because this is a global position, you will be working closely with people from different European countries and may be expected to travel. You’ll work from both your home office and the office in Brussel or Evergem (with occasional travel to France / Germany).

Tasks & responsibilities

• With your expertise in Biologicals/Vaccines, you are responsible for all regulatory aspects from the development of new products to change management in Europe and assigned geographies
• You anticipate changes in the regulatory environment and evaluate the impact on projects and existing products
• As a global regulatory representative in interdisciplinary teams, you develop registration strategies, implement the regulatory plan, and follow the progress of marketing applications in Europe
• You write, review, and approve the development, maintenance and supporting documents from a regulatory perspective
• You are accountable for EU procedures, from pre-submission activities, over dossier preparation to the end of the procedure working in close cooperation with the European Medicines Agency and local authorities
• You are the key point of contact for internal and external stakeholders regarding technical and procedural regulatory aspects
• You monitor emerging trends and integrate new requirements into registration and approval strategies
• You cultivate professional working relationships with regulatory authorities and represent the company’s interests in external forums such as industry associations

Candidate profile

What you should bring to the team:

• Advanced degree in life sciences (e.g., veterinary medicine, biotechnology, biology), preferably Doctoral degree in life sciences or veterinary medicine
• Over 15 years of experience in Regulatory Affairs and excellent knowledge of EU regulatory legislation and requirements for the development and maintenance of Biologicals
• Experience in Regulatory Affairs outside the EU with knowledge of the local specificities of the regulations and/or regulatory processes
• Plus 10 years of successful experience with European regulatory procedures (CP, DCP, MRP) and dossier content
• A Master level in Regulatory Affairs and/or equivalent exposure to Animal Health Regulatory Network is a plus.

Team worker in an international environment

• Ability to represent the RA function in multifunctional teams and ability to identify the at stake situations, priorities, and the stakeholders needs
• Ability to challenge the status quo and collaborative mindset
• Leadership skills

Communication

• Ability to negotiate and influence different internal and external partners
• Good connections with the different functions of R&D and Strategic Marketing and good network with authorities
• Excellent command of English language, German and/or French is a plus

Mentoring/Coaching

• Ability to transmit knowledge and develop people know-how
• Enthusiasm in developing, mentoring, or coaching people (junior or senior managers, newcomers, trainees)

The offer

Next to the great opportunity to develop yourself while learning within the fast-paced environment of their European MIDI region:

• Work in a wellbeing-oriented organisation (Premium access to Headspace and ongoing support and initiatives related to ways of working to help our employees to stay healthy and constantly improve their physical, emotional, mental, and spiritual well-being)
• Customised Development plan based on your role and aspirations, with several learning platforms such as LinkedIn Learning Premium, and access to international development opportunities and training programs
• A competitive salary range based on seniority and specialist skills
• Hybrid workplace model – a mix of working from home within the respective country and from the office/lab location
• A diverse and fun team

Interested?

You can apply to this position by using the link below. For more information please contact  Eda Günes, +31 6 10 46 76 39.