Senior Manager, Regulatory Affairs

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Manager Regulatory Affairs - Make an Impact at the Forefront of Innovation

The Manager Regulatory Affairs manages a team within the department and provides innovative solutions including regulatory expertise and client interface to provide strategic regulatory intelligence and guidance for product development from preclinical through registration and product optimization.


What You'll Do:
• Manage staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations. Approve courses of action on salary administration, hiring, corrective action, and terminations. Review and approve time records, expense reports, request for leave, and overtime. Promote all aspects of Equal Employment Opportunity policy and Affirmative Action Plan. Assure department adherence to good ethical and regulatory standards.
• Act as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients; manage the coordination of and ensure quality performance for key client projects. Manage and review project budgeting/ forecasting. Participate in and/or leads project meetings.
• Finalize and review regulatory documents and submissions.
• 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 modification.
• Collaborate with business development in pricing and securing new business by making presentations to clients, and developing proposal texts and budgets in collaboration with other departments.
• Provide staff with up-to-date legislation and guidance as it becomes available.
• Ensure compliance with relevant organizational and departmental SOPs and WPDs

Education & Experience Requirements:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years).
• 3+ year of leadership responsibility

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, Abilities:
• Strong English language communication and negotiation skills, as well as local language where applicable, both oral and written
• Solid understanding of global/regional/national country requirements and regulatory affairs procedures for clinical trial authorization, licensing and lifecycle management
• Thorough understanding of ICH and other global regulatory guidelines
• In-depth knowledge of at least one of the regulatory speciality areas: preclinical, clinical, CMC, publishing, etc.
• Strong understanding of budgeting and forecasting with the ability to interpret data with attention to detail and analytical and investigative skills
• Capable of supervising, evaluating, and mentoring departmental personnel
• Capable of delegating tasks and facilitating the completion of assignments
• Capable of driving innovation in developing new ideas related to process improvements
• Strong organizational, judgment, analytical, decision-making and interpersonal skills to manage complex projects in parallel and manage rapidly changing priorities
• Effective computer skills, including the use of Microsoft (MS) Word, MS Excel, Adobe Acrobat, etc.
• Capable of independently assessing sponsor needs and working with project team members in producing compliant deliverables
• Capable of independently learning new technologies


Working Conditions and Environment:
• Work is performed in an office or clinical environment with exposure to electrical office equipment.
• Occasional drives to site locations. Potential occasional travel required.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.