Regulatory Associate, Global regulatory Operations

Immedica Pharma AB; Stockholms kommun; Hybrid; SEK 520,000 - 700,000; Full time

Benefits offered by this job

Hybrid work model

Office in Stockholm

Job summary

Immedica Pharma AB in Stockholm seeks a Regulatory Operations Associate to strengthen Global Regulatory Operations. You will help manage submissions, data quality, and regulatory systems across the product lifecycle.

The role reports to the Regulatory Director, works with international partners and internal teams, and offers a hybrid setup from our Stockholm HQ. Fluency in English is required; Swedish is a plus.

Qualifications

• University degree in life sciences, pharmacy, information management or computer science.
• Experience in pharma/biotech industry or CRO is beneficial.
• Experience in regulatory operations, eCTD publishing, and health authority gateways (EMA Gateway, CESP, FDA ESG NextGen) is advantageous.

Responsibilities

• Global regulatory submissions, variations, renewals, and lifecycle maintenance.
• Plan and perform eCTD publishing and electronic submission.
• Manage submissions through health authority gateways and portals.
• Coordinate regulatory document management, templates, and archiving.
• Maintain regulatory data in RIMS and support system improvements.

Skills

Regulatory operations

eCTD publishing

Regulatory information management

Regulatory submission

Health authority portals

Data quality

Cross-functional collaboration

English proficiency

Education

Relevant university degree (life sciences, pharmacy, information management, computer science)

Tools

Veeva RIM

LifeSphere

Lorenz

EXTEDO

Job description

Immedica 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 responsibilities

As 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 qualifications

We 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.

You 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 Immedica

At 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 approach

We 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.

About Immedica

Immedica 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 5 0 countries.