(Senior) Regulatory Affairs Manager - Europe - Home-based
Multiple Locations: Poland • Czechia • Romania • Serbia
Requisition Number: 5466
Position Title: Manager, Regulatory Affairs
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of almost 2,500 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
What you will do
- Review study budgets and costing pertaining to contract negotiation, participate in business development activities, prepare regulatory sections of proposals and feasibility reports and attend bid defense meetings to meet business needs
- Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions and ensure accurate compilation, management and tracking of submissions
- Provide expert regulatory advice and contribute to regulatory project work. Effectively communicate status of submissions with the Sponsor, Project Manager, CSSL, RCL, SCL, CRAs, Medical & Scientific Affairs staff. Contribute towards the preparation of technical documentation such as IMPDs and IBs, review and make recommendations on all relevant documentation to ensure compliance with ICH GCP & country specific requirements
- Provide training, coaching and mentoring to other members of staff and line manage other members of team
What you will bring to the role
- Clearly, proven leadership and organizational management skills are essential attributes
- Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills
- Excellent written and verbal communication skills to clearly and concisely present information
- Relationship-building competency combined with demonstrated comfort supporting Business Development at face-to-face meeting
- Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
- Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
- Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience
- Previous experience within the pharmaceutical/CRO industry
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!
Employment Type: Regular
Community / Marketing Title: (Senior) Regulatory Affairs Manager - Europe - Home-based
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.