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
Apply via :
jobs.thermofisher.com
