Regulatory Affairs Manager
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
About this role
TFS HealthScience is a leading global mid size Contract Research Organization 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.
The Regulatory Affairs Manager (Freelance 0.5 FTE) is responsible for hands on preparation coordination and execution of global regulatory activities for clinical trials. This role supports regulatory submissions authority interactions and regulatory strategy within assigned study teams.
As part of our SRS/FSP team you will be dedicated to one sponsor a global pharmaceutical or biotech company that is an industry leader in international clinical development.
Key Responsibilities
Prepare review and compile global regulatory submissions for clinical trials
Coordinate and manage regulatory authority interactions and responses
Submit and support clinical trial applications in the EU and other regions
Develop regulatory documentation for submissions and scientific advice meetings
Maintain regulatory trackers and electronic files in compliance with SOPs
Provide regulatory guidance and strategic input to sponsor teams
Qualifications
Bachelors degree in life science pharmacy or equivalent
Minimum 5 years of relevant regulatory affairs experience
Strong understanding of GCP ICH guidelines and Clinical Trial Regulation
Ability to work independently in a fast paced environment with shifting priorities
Excellent communication skills and proficiency with standard software tools
What We Offer
We provide a competitive compensation package and the opportunity for personal and professional growth in a rewarding environment. You will join 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 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 guide decision making at all levels and help us attract and retain talent who share these principles. By aligning on these values we cultivate a unified team committed to innovation excellence and making a real impact.
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
