Senior/Manager, Regulatory Affairs - Europe - Home-based

Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications from discovery to reality.Anchored in our companys scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.

Our talented team of 3,000+ professionalsspans 60+ countries.We are united in cause with our customers to improve the lives of patients through new and innovative therapies

Why Worldwide

We believe everyone playsan important rolein making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.Join us!

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, 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 junior members of staff, may be required to line manage junior members of staff

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

Your experience

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR
• Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and eight years experience within clinical research (e.g. CRA, Reg Affairs.)
• Minimum 5 years within pharmaceutical/CRO industry, with demonstrated senior level regulatory or clinical start-up experience
• Proficient in cross-cultural communication and proficient in both spoken and written English

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