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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 is a dedicated group of Regulatory Science Specialists with long term regulatory experience. We are assisting Pharma and Biotech companies in achieving their major regulatory milestones by thoroughly understanding the sense of urgency that applies to this business area.

Joining the IWA Consulting team implies a unique opportunity to learn, develop professionally, and make good use of your knowledge in a vital role to the clients. By combining strategic, scientific, and operational expertise, IWA Consulting ensures 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.

Medical/technical writing:
• Medical/technical writing for pharma products.

Teaching/speaking at courses and conferences:
• Teaching/speaking at courses, conferences or similar on various subjects according to existing and acquired key competencies.

Your qualifications include a Master’s Degree in life science or equivalent combined with solid
experience with the regulatory scientific disciplines. You are passionate about regulatory science and
you have the ability to identify regulatory risks and opportunities and develop regulatory strategies
based on your thorough understanding of Regulatory guidance and your scientific mindset.

You have excellent communication skills (English is a must) and communicate efficiently with
stakeholders at all organisational levels and within all scientific diciplines (quality, non-clinical,
clinial). Further, you have good organizational and interpersonal skills, with the ability to manage
multiple priorities and work with tight deadlines, while beeing collaborative and consultative toward
the clients, developing effective working relationsships.

You are a person with a proactive and responsible attitude and are driven by a high commitment to delivering results on time, every time. You are flexible, service-minded and adaptable and you can handle and deliver on routine jobs when nessesary, while at the same time, you are not afraid to learn new things and do things differently.

IWA Consulting offers an exciting and challenging position in a well-consolidated company with a short line of command and a high degree of flexibility in your everyday life. You will join a company that prides itself of having deep insight and thorough understanding of the regulatory field for medicines, medical devices, and combination products and work together with highly skilled and experienced colleagues.

Domicile: Depending on the clients’ needs the work may be carried out on-site at the clients’ offices as part of their team of regulatory specialists, or from the IWA Consulting offices in Køge or in Copenhagen, COBIS Science Park.

For more details about the job or the company, please contact COO Morten Andersen, Unique Human Capital on M: +45 29 47 30 60 or Senior Research Consultant, Jeanne Dederding, Unique Human Capital on M: +45 28 74 58 71. All applications must be in English and are treated confidentially.

IWA Consulting is a regulatory consulting company providing a complete portfolio of regulatory services to support the development and registration of drugs, biologics, and medical devices. IWA Consulting is a dedicated group of Regulatory Science Specialists providing expert services to a range of international private and public clients – based on their long-term regulatory experience, in-depth knowledge, and expertise. IWA Consulting believes, that having the courage to give honest advice and trust and doing things right from the beginning, is the fastest and most efficient route to reach the goal.