Regulatory Affairs Mgr

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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

You will be part of a global team providing innovative regulatory solutions, owning regulatory affairs responsibilities, and leading discussions with internal and external clients.

You will also be coordinating global regulatory strategies on assigned (Phase 1 to 4) clinical trials, studies and projects and providing the technical / project leadership across regions, supporting our clients with strategic regulatory intelligence, and guidance for the product development mainly during the clinical phases.

The role also supports and leads the preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements, also acts as liaison with internal and external clients.

You will act as a representative of the regulatory department with other departments, supporting business development, working on initiatives, and contributing to quality improvement. You will also arrange, lead, and report on client and regulatory agency meetings.

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

Knowledge, Skills and Abilities :

Skills Required

Project Management, regulatory strategy, Microsoft Word