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Regulatory Affairs Manager

2 months ago

Stockholm, Stockholm, Sweden Norrsken Launcher Full time
About the Role

We are seeking a highly skilled Regulatory Affairs Manager to join our team at Norrsken Launcher. As a key member of our organization, you will play a critical role in driving and securing EFSA applications and managing all regulatory matters related to EFSA and animal science.

Key Responsibilities
  • Research Strategy Development: Develop and implement research strategies aligned with our vision and goals, as well as EFSA's guidelines and priorities.
  • EFSA Application Management: Manage and complete the preparation and submission of applications to EFSA, including project managing all resources, external research partners, regulatory agencies, and other stakeholders.
  • Quality Assurance: Establish and maintain quality assurance processes and protocols to ensure the safety, efficacy, and reliability of our studies and applications.
  • Regulatory Compliance: Ensure compliance with regulatory requirements and scientific standards.
  • Stakeholder Partnerships: Establish and maintain strong partnerships with external research institutions, academic organizations, and industry stakeholders to leverage expertise and resources, share knowledge, and identify collaboration opportunities.
  • Risk Management: Manage risk assessment and risk management strategies to mitigate identified risks.
  • Trend Identification: Identify emerging trends, technologies, and opportunities in Agritech.
Requirements
  • Education: PhD or MSc in Animal Science, Agricultural Science, or Biotechnology.
  • Leadership Experience: Proven track record of leadership in research and development, with significant experience in Agritech or related industries.
  • Animal Science Expertise: Deep animal science skills with experience and understanding of cattle and in vivo/in vitro execution.
  • EFSA Application Expertise: Proven track record of managing and securing EFSA applications from start to finish.
  • Project Management: Excellent project management skills, tools, and processes.
  • Regulatory Knowledge: Deep regulatory knowledge with in-depth understanding of EFSA regulations, guidelines, and requirements, as well as familiarity with relevant national and international regulatory frameworks.
  • Network and Relationships: Great network and relationships with professionals within animal science/EFSA.
  • Risk Management: Experience in risk management, processes, tools, and reporting.
  • Attention to Detail: High attention to detail.
  • Entrepreneurial Mindset: Entrepreneurial mindset, with a passion for innovation and driving results in a fast-paced environment.
  • Communication Skills: Excellent written and verbal communication skills in English (Swedish skills a plus).
  • Collaborative Style: Collaborative working style, thriving in helping colleagues grow and succeed.
About Us

We are a mission-driven team dedicated to driving a positive impact on the planet's future. Our team is founded by Martin Blomberg, MSc in Medical Biotechnology from KTH and Tommi Remonen, MSc and a PhD in Organic Chemistry from KTH.

We thrive in an innovative, collaborative, and inclusive work environment within the Norrsken community. We are scaling quickly and there will be ample opportunities for personal learning and development.

We offer comprehensive benefits, including a wellness allowance, technology tools of your choice, and competitive insurances. We work in the Norrsken co-working space in central Stockholm, surrounded by impact entrepreneurs, and we are also open for hybrid or remote working within the European Union.