Senior /Regulatory Affairs Manager (Global Clinical Trial Applications) | Thermo Fisher Scientific

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, (comparable to 9+ years.)
• Proven project management experience, and experience performing effectively in a client facing role

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• 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;
• Superb understanding of medical terminology, statistical concepts, and guidelines
• Excellent analytical, investigative, and problem-solving skills
• Excellent understanding of budgeting and forecasting