We are currently seeking a Regulatory Affairs Manager to join our global Regulatory Affairs department – Regulatory Science team. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting.

Responsibilities: 

• Lead the preparation of global regulatory submissions and ensure high quality standards that meet local and regional requirements.
• Act as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and for key client projects of moderate to high complexity.
• Provides internal clients with up-to-date legislation and guidance as it becomes available.
• Ensure quality performance for key/managed projects.
• Manage project budgeting/forecasting functions.
• Identify and recognize out of scope activities in a contract in a timely manner and liaise with other departments to follow through on all aspects of contract modifications.
• Collaborate with business development in pricing and securing new business by making presentations to clients and developing proposal texts and budget in collaboration with other departments.
• Provides matrix/project leadership, training and guidance to junior team members.
• Ensure compliance with relevant organizational and regulatory SOPs and WPDs.
• Participate in launch meetings, review meetings and project team meetings.

Qualifications – External

• What the role requires you to have:
  Bachelor’s degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job, at least 5 years.
• Proven project management experience, and experience performing effectively in a client facing role