Regulatory Affairs Project Manager
il y a 2 jours
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.
**Join Our Team as a** **Regulatory Affairs Project Manager**
**About this role**
- As part of our _**_Strategic Resourcing Solutions_**_ team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals._
The **Regulatory Affairs Project Manager **is responsible for working operationally
on preparing, conducting and completing Regulatory Affairs tasks in assigned Study Teams, according to company policies, SOPs and regulatory requirements
**Key Responsibilities**:
- Maintenance of electronic files and trackers as required.
- Developing regulatory documents for clinical trial submissions and scientific advice meetings.
- May act as a Project Lead for REG-only projects.
- Participate in relevant meetings. Forward information to relevant members of the department or study team members.
**Qualifications**:
- Bachelor’s Degree, preferably in life science or pharmacy; or equivalent 5 years of relevant experience.
- Able to work in a fast-paced environment with changing priorities.
- Understand the basic terminology and science associated with the assigned drugs.
- Understanding of the Good Clinical Practice regulations, ICH guidelines, Clinical Trial Regulation and internal SOPs
**What We Offer**
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll 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.
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