Regulatory Associate, Global regulatory Operations

About the roleImmedica Pharma has experienced remarkable growth in recent years, and we are now looking for a Regulatory Associate to further strengthen our Global Regulatory Operations Team. In this position, you will contribute to our mission to make a meaningful difference in patients' lives by providing innovative therapies within our core therapeutic areas. You will join an international and collaborative organization where quality, ownership and a strong patient focus are central to how we work. This is an excellent opportunity for someone who wants to develop within global regulatory affairs and regulatory technology in a growing Swedish company with a genuinely international environment. You will play an important role in ensuring efficient submission management, high-quality regulatory data and the effective use of regulatory systems throughout the product lifecycle. Immedica's Global Regulatory department currently comprises eighteen colleagues, and we are now looking for a Regulatory Operations Associate to strengthen our global Regulatory Operations capabilities. Job description and responsibilitiesAs a Regulatory Associate, you will be part of the Regulatory Operations Team, Global Regulatory Department at our headquarter in Stockholm and report to Regulatory Director. You will work closely with colleagues across all headquarter functions as well as with external partners and service providers.Your main responsibilities will include:Global regulatory electronic submissions, including variations, renewals, responses and lifecycle maintenance.Plan and perform eCTD publishing, technical validation, and electronic submission.Manage electronic submissions through relevant health authority gateways and portals, such as EMA Gateway, CESP and FDA ESG NextGen.Coordinate regulatory document management, templates, metadata and inspection-ready archiving.Maintain accurate regulatory data and records in RIMS, including registrations, submissions, commitments, Health authority correspondence and key milestones.Support implementation, validation, maintenance and continuous improvement of regulatory systems, tools and processes.Prepare regulatory metrics and reports, and contribute to SOPs, work instructions, training materials and process improvements. Experience and qualificationsWe are looking for someone with a relevant university degree, for example in life sciences, pharmacy, information management, computer science or a related discipline. Previous experience from the pharmaceutical or biotechnology industry, a CRO, or Regulatory is beneficial, but not a strict requirement.Furthermore, experience in the following areas is considered an advantage :Regulatory operations, submission management or Regulatory support.eCTD publishing, technical validation and electronic submission processes.Regulatory Information Management System (Veeva RIM, LifeSphere for example).Regulatory publishing or validation tools such as Lorenz, EXTEDO or equivalent platforms.Health authority submission gateways and portals, such as EMA Gateway, CESP or FDA ESG NextGen.Regulatory document management, data quality, reporting or system administration.International or cross-functional collaboration.Excellent written and spoken English is a requirement. Knowledge of Swedish is an advantage.Personal qualitiesYou are structured, curious and quality-focused, with an interest in systems, data and efficient processes. You learn quickly, enjoy solving problems and are comfortable taking ownership in situations where the answer is not always obvious.In addition, we believe you are collaborative, service-minded and clear in your communication. You enjoy working across functions and cultures and contribute with a practical, positive and improvement-oriented mindset. Working at ImmedicaAt Immedica, we value people who take ownership, build trust and work well in collaboration with others. We believe you are structured and proactive, with the ability to balance attention to detail with an understanding of the bigger picture.You will be part of an environment characterized by entrepreneurship, drive and a shared ambition to keep improving how we work.At Immedica, our core values Open & Honest, Effective and Empowered form the foundation of our culture and guide how we operate, innovate and collaborate. They shape our commitment to patients, partners and colleagues.This is a full-time position based at our office in Torsplan, Stockholm. The role offers a hybrid working arrangement, but you are expected to work from the office three to four days a week and should therefore be based within commuting distance. Our recruitment approachWe aim to run a fair and structured recruitment process. This means that we focus on the skills, experience and behaviors that are relevant for the role, and we work actively to reduce bias throughout the process.We welcome applications from candidates of all backgrounds, experiences and perspectives. We believe that different perspectives make us stronger as a company and help us better understand the patients, partners and communities we serve. We value diversity and inclusion and place considerable emphasis on personal qualities and alignment with Immedica's core values. How to applyIf you would like to be considered for the role, please submit your application through our career page, found in the "Apply now". We require you to upload a resume and answer a few questions to submit your application.We review applications on an ongoing basis, so we encourage you to apply as soon as possible. About ImmedicaImmedica is a pharmaceutical company headquartered in Stockholm, Sweden, focused on bringing medicines for rare diseases and conditions with high unmet medical needs to patients globally.We are around 185 employees across Europe, North Africa, the Middle East, and the United States, supporting patients in more than 50 countries.