Regulatory Affairs Manager

About this role

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing and Functional Service (FSP) solutions.

As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical/biotech company that is an industry leader in different Therapeutic Areas.

We are currently looking for a Regulatory Affairs Manager with global clinical expertise in regulatory affairs.

The Regulatory Affairs Manager is part of the Project Delivery organization and will work operationally on preparing, conducting and completing Regulatory Affairs tasks in assigned Study Teams, according to company policies, SOPs and regulatory requirements.

This is a freelance role requiring a commitment of 1-2 days per week, and the candidate is expected to work on-site in an office located in Copenhagen.

Key Responsibilities

• Provide regulatory services to support international multinational clinical trials in accordance with client requests.
• Prepare, review, and compile regulatory submissions.
• Liaise with regulatory authorities and provide expert advice on regulatory questions/issues.
• Maintain electronic files and regulatory trackers as required.
• Submit and support clinical trial applications to regulatory authorities within the EU.
• Develop regulatory documents for clinical trial submissions and scientific advice meetings.
• Act as a Project Lead for regulatory-only projects when required.
• Provide regulatory strategy and guidance to sponsors and internal teams to ensure compliance with regulations.
• Participate in meetings, share regulatory intelligence, and contribute to continuous improvement initiatives.
• Assist in the development and maintenance of department SOPs and tools.
• Stay updated on international regulatory requirements and procedures.
• Provide training and supervision to new regulatory personnel.

Qualifications

• Bachelors Degree, preferably in life sciences or pharmacy, or equivalent experience.
• Minimum of 5 years of relevant experience in regulatory affairs within clinical research.
• Strong understanding of Phase II-III.
• Knowledge of Good Clinical Practice (GCP) regulations, ICH guidelines, and Clinical Trial Regulations.
• Ability to work independently and collaboratively within a matrix organization.
• Excellent written and verbal communication skills in English.
• Strong organizational skills and ability to manage multiple tasks effectively.
• Proficiency in Microsoft Office Suite (Word, Excel, MS Project).

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. Youll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.