Director, Regulatory Affairs
TFS, United States
Job Description
TFS is a Global CRO headquartered in Sweden. We genuinely believe that Global in mind and local at heart is the core of our success; we operate in a global environment while retaining an in-depth knowledge of regulatory requirements in every country where we operate. At TFS, you will be offered the possibility to develop in a global organization with a company culture distinguished by passion, innovation and talent.
Director Regulatory Affairs position is part of the Clincial Development Services organization supporting both the Centres of Excellence and the Study Startup groups.
It will provide TFS clients with expert input into the design and implementation of clinical development programs of pharmaceutical products and medical devices in the field of interest and the assigned therapeutic area.
Key Responsibilties:
- Support the Centres of Excellence and Business Development with new RFPs and regulatory strategies for drug/device development and clinical trials/investigations
- Support the strategy teams at the Centres of Excellence to draw a regulatory and Startup strategy for new RFPs/Projects
- Support setting up country regulatory and startup intelligence
- Support setting up new systems for Startup
- Support capabilities and bid defense meetings
- Collaborate and communicate with other clinical development departments
- Support development of new processes and implementation for the unit
- May identify and develop new strategic initiatives including process improvements
- Interact with senior management across disciplines
- Ensure that the unit follow TFS SOPs amp; guidelines, local laws and regulations are followed
Requirements
- Bachelor’s Degree, preferably in life science or nursing; or equivalent
- 10 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
- Ability to work independently as well as in a team matrix organization with little or no supervision
- Excellent written and verbal communication skills
- Detail oriented
- Demonstrate proficiency using typical word processing; spreadsheets desirable; and presentation software a plus
Benefits
What can we offer you?
A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients.