Global Reg Affairs Lead (Reg Affairs AD) - FSP

Position Overview

• Location Type: Global (Remote)
• Employment Type: Full-time
• Salary: Not specified

Job Description:

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

This is a client-dedicated role for a Regulatory Lead. This is a strategic role to support indications, including early indications, early development and late development, and that can support later development (e.g., Phase 2 to BLA). Global experience is a must as that reflects the nature of our client developments.

Essential Functions

• Provides regional lead review and technical advice to prepare regional and/or global regulatory submissions and ensure high quality standards that meet or exceed client expectations, local and regional requirements.
• Acts as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and oversees key client projects of the highest complexity.
• Provides internal clients with up-to-date legislation and guidance as it becomes available.
• Ensures quality performance for key/managed projects.
• Manages project budgeting/forecasting functions.
• Identifies and recognizes out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.
• Major involvement in reviewing Protocol and ICF with a critical mindset.
• Point of contact for Health Authorities and internal stakeholders like business and marketing.
• Main responsible for Response to Questions from Health Authorities.
• Collaborates with business development in pricing and securing new business by making presentations to clients, and develops proposal texts and budgets in collaboration with other departments.
• Provides matrix/project leadership, training and guidance to junior team members.
• Oversee and interact with the RALs working for the development program.
• Ensures compliance with relevant organizational and department SOPs and WPDs.
• Participates in launch meetings, review meetings and project team meetings.
• May lead departmental initiatives/project teams.

Requirements

• Education and Experience: Bachelor’s degree or equivalent and relevant formal academic / vocational qualification.
• Previous Experience: Previous experience providing the knowledge, skills, and abilities outlined below.

Responsibilities

• Provide regional lead review and technical advice for regulatory submissions.
• Serve as a subject matter expert in regulatory strategy and technical expertise.
• Stay up-to-date on legislation and provide guidance to internal and external clients.
• Ensure quality performance for key/managed projects.
• Manage project budgeting and forecasting.
• Identify and address out-of-scope activities in contracts.
• Review Protocols and ICFs with a critical mindset.
• Serve as a point of contact for Health Authorities.
• Respond to questions from Health Authorities.
• Collaborate with business development on pricing and new business opportunities.
• Provide leadership, training, and guidance to junior team members.
• Oversee and interact with RALs.
• Ensure compliance with SOPs and WPDs.