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Head of Regulatory Affairs

Unique opportunity of setting up the structure and function of Regulatory Affairs in a growing biotech startup.

The position as Head of Regulatory Affairs (RA) is a newly established position and the person will be the first RA Professional at SNIPR Biome.

It is a unique opportunity to work with the latest technologies in a biotech company that aims to be able to make targeted microbiome engineering with their CRISPR-based precision medicines. SNIPR Biome is in the process of expanding its pipeline with more drug candidates and is putting considerable emphasis on the upcoming clinical development of its own products.

It is a once in a lifetime opportunity to be part of setting up the structure and function of Regulatory Affairs. As Head of Regulatory Affairs, you will be part of the team driving SNIPR’s development projects further. You will play a key role and provide effective support to the organization to ensure the best development programs for your designated projects.

With direct report to the COO.

Your main tasks are:

  • Be the lead driver and owner of all regulatory interactions and applications.
  • Support to and preparation of INDs and clinical trial applications.
  • Collaborate with project teams with e.g. scientific advice preparation, orphan drug designation applications and investigation plans including writing and supporting regulatory communications.
  • Broad support to Quality, CMC and Clinical with regulatory activities.
  • Contribute to internal regulatory policies and procedures to achieve best practices and work processes by writing SOPs.
  • Supporting the company through regulatory intelligence efforts in staying abreast of newly issued regulatory laws, guidance and technical publications.
  • Identify relevant CRO’s and establish collaboration.
  • Collaborate with authorities.
  • Setting the standard and ensuring continuous improvement and adaptation to the company’s needs from early development through commercialization.

You have a proven record of accomplishment and you have more than 5 years of documented professional experience from a regulatory affairs position in the Pharma industry. Moreover, it is expected that you have experience with interacting directly with regulatory authorities on an international scale, including interactions at different stages of drug development, e.g. scientific advice, pre-IND, IND etc. both within the EU and the US. You are a generalist who is comfortable with a variety of disciplines including CMC, Quality, Non-Clinical and Clinical areas. You can drive ambitious regulatory plans and timelines and you have detailed knowledge of related rules and regulations, and best regulatory practices. Dossier preparation experience in the EU and the US is a plus. Finally, you must be able to think in an innovative manner within the regulatory area.

You have a Master’s Degree in Pharmaceuticals, Chemical Engineering or similar.

You are a person who can work independently and who has the experience to make critical decisions. You are comfortable with a risk-based approach to decision making, and you are comfortable in a dynamic environment in which priorities and drivers can change quickly. You are clear in your communication towards upper management, quality-driven and you are robust and able to stand firm. Finally, you are open-minded and like to have fun although working in an “ICH/GMP regulated environment”.

At SNIPR Biome, you will be a part of an international, entrepreneurial and informal working environment with the exciting possibility to work in a novel therapeutic area and making a difference.

Travelling: 20 days per year.

Domicile: SNIPR Biome resides in an entrepreneurial office facility with a rooftop terrace and a wonderful view of Copenhagen.

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 Research Consultant Elisabeth Haun, Unique Human Capital on M: +45 28 90 33 88. 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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