Regulatory Affairs Specialist
Ageing is one of the greatest challenges of our time. As the major risk factor for diseases and functional decline, it is at the root of the most devastating health problems we face. Science has demonstrated that we can slow the ageing process and extend the lives of animals in the laboratory.
At EPITERNA, our mission is to translate these breakthroughs into longer and healthier lives for both pets and people. Our team develops affordable products that can safely slow the ageing process to prevent age-related disease, delay functional decline, and extend life.
We have sufficient funding from investors who are deeply aligned with our mission, so while we are an early-stage start-up, we have the necessary resources to develop best in class research and clinical infrastructure.
We are looking for a Regulatory Affairs Specialist to guide us through the complex regulatory processes involved in creating new products and repurposing existing ones to slow down the aging process. Our goal is to work with local and European authorities to establish innovative regulatory pathways for introducing to the market aging therapeutics for both pets and people.
What you will do
Develop and carry out regulatory strategies to secure necessary permits for clinical trials, ensuring safety and ethical standards are met.
Ensure our clinical trials and product development adhere to best practices, guidelines, and Good Clinical Practice (GCP) standards for easier product approvals.
Work with a diverse team (scientific research, clinical research, legal) to design clinical trials that fulfil regulatory requirements to facilitate product approvals.
Prepare and submit essential regulatory documents, like product registration applications and technical files, to European authorities while maintaining accuracy and completeness.
Regularly track updates in European veterinary rules, guidelines, and industry trends, and share pertinent information with your team to guarantee compliance.
Serve as the main contact between our company and European regulatory agencies, building strong relationships and ensuring effective communication.
Review promotional materials, labels, and packaging for compliance with European regulatory requirements and offer guidance for any necessary adjustments.
Support internal and external audits by helping and advice on regulatory matters related to product repurposing and licensing.
What you are bringing
A Bachelor's or Master's degree in a relevant scientific field (e.g., biology, chemistry, or pharmacology) or similar experience.
Solid experience in regulatory affairs, ideally in the veterinary or animal health industry, working with new drugs, repurposed approved drugs or licensing generic drugs.
A history of successfully preparing and sending regulatory documents for new or repurposed products, leading to product approvals in Europe.
Deep knowledge of local and European veterinary rules, guidelines, and best practices for developing, repurposing or licensing pharmaceutical products.
Good problem-solving skills and the ability to understand complex information and make decisions based on it.
Great written and spoken English communication skills, with the ability to clearly explain complex ideas to different people.
Being well organised, good at managing projects, and able to handle multiple tasks at the same time.
A team player who enjoys working with others and can adapt to a growing startup environment where processes and responsibilities are still being developed.
What you will find
We are a small but growing team of ambitious scientists, physicians and engineers. We understand that our mission will not be simple or quick, but we are determined to create more time that matters.
We are a highly collaborative, interdisciplinary, and pragmatic team and care deeply about creating a company culture that allows everyone to thrive and grow.
We are committed to rethink how we provide healthcare, from treatment of diseases to preventive care and from just extending health to slow down aging and extend life. If you want to deliver the very best outcomes to your patients rather than following common wisdom of how healthcare works, you will love it here.
Our processes, company size and personal responsibilities are not yet established and will change faster than in a corporate environment. This means there is a lot of room for you to take responsibility and move fast, but it can also be overwhelming at times.
We would like you to join as soon as possible.
The position will be based in Spain (it’s a beautiful country with a great quality of live). We work mostly on-site. We believe this is important especially now at the beginning so we can share together EPITERNA’s culture.
Although it won’t be a rule, you’ll probably need to travel. We value close contact with our collaborators and partners.