Regulatory Affairs Director

4 weeks ago

London, Greater London, United Kingdom Lifelancer Full time
Senior/Manager, Regulatory Affairs

At Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), we work in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications from discovery to reality.

Our company is anchored in our scientific heritage, focusing on cardiovascular, metabolic, neuroscience, oncology, and rare diseases. We develop flexible plans and solve problems quickly for our customers. Our team of 3,000+ professionals spans 60+ countries and is united in cause with our customers to improve the lives of patients through new and innovative therapies.

We believe everyone plays an important role in 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.

Key Responsibilities
  • 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.
About the Role

We offer an estimated annual salary of $120,000 - $160,000 depending on location and experience, along with a competitive benefits package including health insurance, retirement plan, paid time off, and opportunities for career growth and professional development.

If you have a minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, or two years of education/training (nursing degree or equivalent life science degree) with eight years of experience within clinical research, then this could be the perfect opportunity for you.

We are looking for someone who is proficient in cross-cultural communication and has excellent written and verbal communication skills to clearly and concisely present information. You will need strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills, as well as the ability to handle multiple tasks in a fast-paced and constantly changing environment.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. If you're interested in this position, please visit our website at https://lifelancer.com for more information and to apply.

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