Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

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.

• 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.

• 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

• Excellent English language (written and oral) communication skills as well as local language where applicable

• Excellent attention to detail and quality as well as excellent editorial/proofreading skills

• Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments

• Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies

• Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects

• Excellent negotiation skills

• Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables

• Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines;

• Excellent analytical, investigative, and problem-solving skills

• Excellent understanding of budgeting and forecasting