We are looking for a Senior Regulatory Science Specialist
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:
- 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.
Required
- 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.
What’s next?
If you recognize yourself in part or in full of this role, we’ll be looking forward to hearing from you. Please apply with a full resume and references that describe your abilities as an enthusiastic Regulatory professional looking to make a difference to health-related product developers and manufacturers. We hire candidates continuously, so we encourage you to submit your application as soon as possible.
Apply now and make your mark, at info@iwaconsulting.dk!
About the Company
IWA Consulting has provided regulatory services for 25 years. We became part of the VCLS group in 2019 and is now bringing VCLS global expertise to Nordic clients. While embarking on a transformational journey with ambitious growth plans, we continue to build IWA Consulting based on Nordic values of flexibility, responsibility and trust urope.
Voisin Consulting Life Sciences (VCLS) is a team of 200+ life sciences professionals specialized in consulting services to innovative life sciences companies: biotechnology, healthtech, and pharmaceutical companies. VCLS supports its clients throughout product development and commercialization from the design of global development plans and regulatory strategies to their implementation and submissions to regulatory agencies and payers. Its expertise encompasses the full spectrum of health products: drugs, biologics, cell and tissue therapies, medical devices/ digital, In-Vitro Diagnostics/CDx, combination products, as well as nutraceuticals and cosmeceuticals.
With team members based across Europe (London, UK; Paris & Rennes, France; Lausanne, Switzerland, Copenhagen, Denmark), the USA (Cambridge, MA and Somerville, NJ), and Asia (China and India (Bangalore)), VCLS is constantly searching for talented people attracted by innovation, geographical and cultural diversity of the organization and its clients, and by the very rewarding and stimulating career opportunities offered to the employees.