Take a vital role in helping life science companies getting their products on market by utilizing your regulatory affairs expertise...
IWA Consulting ApS is part of the global VCLS group with objectives and ambitions to grow our Nordic business. As (Senior) Regulatory Science Specialist you will implement regulatory strategies for development, registration and maintenance of innovative drugs and biologics for our clients, with the seamless support of our local or global team as relevant.
Joining our team in Copenhagen implies a unique opportunity to learn, share, develop professionally, and make good use of your knowledge in a vital role to the clients. By combining strategic, scientific, and operational expertise, we ensure successful execution of regulatory submissions throughout the development phase, the registration phase, and the post-approval phase thereby supporting the clients’ key business goals.
You will assist clients with a variety of regulatory tasks including the following:
Regulatory Strategy preparation:
- Prepare regulatory strategies and provide input to regulatory strategies for pharma projects. Identify and provide relevant regulatory guidance to clients, incl. defining the regulatory path.
Project Management and Procedure Management:
- Project Management for regulatory activities on pharmaceutical products, incl. management of US and EU regulatory procedures (incl. MAA, NDA, IND, CTA, ODD, PIP, variations, renewals, and other post-approval activities).
- Planning, coordinating and participating in meetings with authorities.
Preparation and submission of all types of regulatory documents and dossiers:
- Preparation and/or review of documentation for regulatory submissions, incl. MAA, NDA, IND, CTA, ODD, PIP, variations, and renewals.
- Preparing for, and review of, eCTD submissions.
Preparation and updating of Product Information text:
- Preparation and updating SmPC, PIL and Labelling.
- Translation of marketing materials
- Medical/technical writing for pharma/biotech products.
Teaching/speaking at courses and conferences:
Teaching/speaking at courses, conferences or similar on various subjects according to existing and acquired key competencies.
- 3-10 years professional regulatory experience in relevant fields
- Consulting experience
- Communication skills and service mindset
- Experience in Project Management
- Strong problem-solving skills
- Adaptable to a dynamic atmosphere in an international environment
- Why should you join IWA Consulting & VCLS – What we offer to you?
- A dynamic workplace with flexible working conditions (hybrid, reduced time), to be tailored to your personal needs to support your desired work-life balance,
- Inspiring work environment with access to our global network and training opportunities,
- Informal working culture between VCLS colleagues from all over the world, including strong Subject Matter Experts in key innovative fields,
- Opportunity to work in a multicultural company with a friendly and dynamic work environment,
- Opportunity to work with the most significant life sciences clients, both locally in the Nordics but also globally,
- Diversity of projects, and possibility of shaping your career path,
- Personal development model which defines your long-term career goals,
- Competitive salary and benefit package.