Purpose Pharma International AB (Purpose Pharma) is a European-based pharmaceutical company focusing on the development and commercialization of innovative rare disease and specialty care products in areas of high unmet medical need. Founded in 2022 by experienced biotech executives and life science investors, Purpose Pharma also operates a dedicated trading unit for unlicensed medicines and exports and seeks to expand its product portfolio across the Nordic and European markets through strategic partnerships.

Further information about the company can be found on: www.purposepharma.com

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Regulatory Operations Manager


Purpose Pharma is looking for a person with regulatory operations and product life cycle management experience from the pharmaceutical industry, with strong knowledge of EU regulatory submissions, including both central EMA procedures and local processes in major EU markets.

This is an opportunity to be part of a competent, experienced and dynamic team with high energy, all very committed to help to improve the quality of life and cure more patients. It is a chance to shape regulatory operations in a growing company.

To succeed in this role, you have a genuine interest and knowledge within regulatory, along with a passion for continuous learning. You are a true team player but also able to work independently and manage multiple priorities. With a positive, solution-oriented mindset and strong communication skills, you are proactive and flexible, always ready to contribute where needed to move projects forward. Excellent organizational skills and attention to detail are also essential.



The Position

As Regulatory Operations Manager, you will play a pivotal role in ensuring the smooth execution of all regulatory activities across at Purpose Pharma. You will be responsible for managing submission processes, maintaining compliance for commercial products, and supporting compliance with European regulatory requirements.

The Regulatory Operations Manager will report to the Chief Operation Officer. The role is a permanent full-time position, located in Stockholm.

Qualifications
• Bachelor’s or Master’s degree in life sciences, pharmacy, or related field
• 5+ years of experience in regulatory operations within the pharmaceutical industry
• Strong knowledge of EU regulatory submission formats and procedures (eCTD, EMA portals)
• Experience with country specific regulatory requirements and processes in bigger EU markets
• Strong written and oral communication skills in English and Swedish
• Computer proficiency (e.g. MS office)


Preferred Experiences
• Experienced with maintaining regulatory product documentation related to marketed product variants. This includes artwork and labelling, product information and local market requirements
• Experience of initiating and completing regulatory tasks independently
• Familiarity with EMA centralized procedures and post-approval maintenance
• Exposure to global regulatory environments (e.g., FDA)
• Experience from small pharmaceutical companies is preferred
• Experience with FMD (serialisation), pharmacovigilance and GDP are a plus but not essential


Competencies

• Excellent organizational skills and attention to detail
• Ability to work independently and manage multiple priorities
• Strong communication and interpersonal skills
• Solution oriented approach, positive and a Team Player
• Ability to communicate clearly both verbally and in writing, both internally and externally
• Structured, driven, self-motivated and professional



Opportunities with the role

• A key position in an innovative, expanding company with a great team spirit
• Short decision-making processes supporting an efficient working environment
• Be part of a competent, experienced and dynamic team with high energy, all very committed to help to improve the quality of life and cure more patients
• Opportunity to shape regulatory operations in a growing company
• Collaborative and mission-driven culture
• Flexible working arrangements


Contact

For more information and questions about the position, please contact Marta Frick Senior Recruitment Consultant at PeakSearch.

Contact details:
Marta Frick marta.frick@peaksearch.se Tel: 070-386 89 69