Regulatory Affairs Manager (Clinical Trial Applications)

Employment Type: Full-time Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office

Position Overview

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.

PPD, the Clinical Research Business of Thermo Fisher Scientific, is now actively recruiting for a highly driven and successful Regulatory Affairs Manager (Clinical Trial Applications) to join our Regulatory Science department.

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.

The role also supports and leads the preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements, also acts as liaison with internal and external clients. You will act as a representative of the regulatory department with other departments, supporting business development, working on initiatives, and contributing to quality improvement. You will also arrange, lead, and report on client and regulatory agency meetings.

This is an individual contributor, not a people manager role.

Responsibilities

• Lead the preparation of global regulatory submissions and ensure high-quality standards that meet local and regional requirements.
• Act as a 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.
• Provide 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

• Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification.
• Previous experience with CTAs 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.
• Experience in IVDR, ATMP, GMO is considered an advantage.

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.