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Head of Regulatory & Legal Affairs
Unique opportunity to set up regulatory and legal affairs function in leading biotech start-up
We are a growing biotech company based in Lund, Sweden which provides gut health testing services and modulators. The position of Head of Regulatory & Legal Affairs is a newly established position in Carbiotix. It is a unique opportunity to join a company taking a lead in the microbiome healthcare industry. You will play a key role in helping the company fulfil its mission of increasing the consumption of prebiotics in people’s diets through a portfolio of microbiome modulators covering prebiotic ingredients, medical foods and therapeutics, and a range of cost effective gut health testing services. As Head of Regulatory and Legal Affairs you will sit in the management team and report directly to the CEO.
Carbiotix is an award-winning, publicly traded, biotech company focused on affordable and effective gut health testing and the production of a second generation prebiotic soluble fibre called AXOS. Carbiotix was founded in 2014 as a spin-off company from the Department of Biotechnology at Lund University, Sweden, the largest university in the Nordic Region and a global top 100 university. The company’s soluble fibre AXOS was selected as a top new ingredient by the Nutrition Capital Network (NCN) in Europe and the US in 2015.
Your main tasks are:
· To take a leading role with regards to all regulatory and legal issues in the company related to the company’s primary business areas.
· To be the main contact person and coordinator with third-party consultants and authorities.
· To manage a diverse set of areas including ISO & GDPR systems, and regulatory processes with the FDA, EFSA and EMA related to ingredients, medical foods and therapeutics.
· Contribute to the support and preparation of applications, related communications, and regulatory intelligence.
You have a proven track record of accomplishment with regards to regulatory and legal affairs and preferably more then 5-years experience from a similar position in the Food & Beverage, Supplement and/or Pharma industries. You have experience interacting with third-party consultants as well as interacting directly with regulatory authorities in the US and EU.
You have a Master’s Degree or equivalent in Pharmaceuticals, Chemical Engineering, Food Engineering or similar
You are ambitious and independent and can take a leadership role with regards to setting goals and meeting timelines. You are comfortable in a dynamic, start-up environment and accustomed to the opportunities presented with this setting. You are comfortable reading, writing and speaking in English and Swedish.
Travelling: 15-20 days per under normal conditions.
Carbiotix is based in Lund, Sweden in the Active Biotech building. Easy access to public transportation (tram stop planned outside office). Many choices of lunch restaurants, access to a free gym in the building, free parking, and close to the E22.
Why Should You Apply?
· Join a start-up company where you can make a big impact and grow.
· Possibility for shares through options agreement.
· Competitive salary.
· Lenient office hours.
· 10% pension savings.
· Ability to change the world and have a real impact on the lives of many people.
All applications must be in English and are treated confidentially. We will process the applications on an ongoing basis.