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Regulatory Science Specialist

Take a vital role in helping life science companies getting their products on the market by utilizing your regulatory affairs expertise!

 

IWA Consulting is a dedicated group of Regulatory Science Specialists with long term regulatory experience. They 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 combined with a few years of experience with some of the regulatory scientific disciplines. You are passionate about regulatory affairs and have a basic knowledge of drug developmebnt and pharmacutical regulatory affairs combined with a 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. This provide a unique chance to develop your skills within the RA diciplin and help build the future of the company.

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 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.

Unique Human Capital A/S
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cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Christiansgade 30
8000 Aarhus C
Vi er over 200 mennesker, der arbejder med viden, kreativitet og teknologi
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