Job Description: Regulatory Affairs Specialist

Position Overview

Thermo Fisher Scientific is seeking a Regulatory Affairs Specialist to participate in the management, preparation, review, and coordination of Country Submissions in line with global submission strategy. This role is crucial in enabling customers to make the world healthier, cleaner, and safer by supporting the development of life-changing therapies.

Employment Type

Full-time

Work Schedule

Standard Office Hours (40/week)

Environmental Conditions

Office

Key Responsibilities

• Prepares, reviews, and coordinates local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g., gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
• Provides, under mentorship, local regulatory strategy advice (MoH & EC) to internal clients.
• Provides project-specific local SIA services and coordination of these projects.
• May have contact with investigators for submission-related activities.
• Serves as a key contact at the country level for either Ethical or Regulatory submission-related activities.
• Coordinates, under mentorship, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed-upon timelines.
• Ensures alignment of the submission process for sites and studies with the critical path for site activation.
• Achieves PPD’s target cycle times for site activation.
• May work with start-up CRAs to prepare regulatory compliance review packages, as applicable.
• May develop country-specific Patient Information Sheet/Informed Consent form documents.
• May assist with grant budgets and payment schedules negotiations with sites.
• Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
• Enters and maintains trial status information relating to SIA activities onto PPD tracking databases accurately and in a timely manner.
• Ensures local country study files and filing processes are prepared, set up, and maintained as per PPD WPDs or applicable client SOPs.
• Maintains knowledge of and understands PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Keys to Success

Education and Experience

• 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 2+ years).

Knowledge, Skills, and Abilities

• Effective oral and written communication skills.
• Excellent interpersonal skills.
• Strong attention to detail and quality of documentation.
• Good negotiation skills.
• Good digital literacy and the ability to learn appropriate software.
• Good English language and grammar skills.
• Basic medical/therapeutic area and medical terminology knowledge.
• Ability to work in a team environment or independently, under direction, as required.
• Basic organizational and planning skills.
• Basic knowledge of all applicable regional/national country regulatory guidelines and EC regulations.

Company Information

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.

Benefits

We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for progress and innovation.