The Quality Difference at Thermo Fisher Scientific: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind. Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that are improving lives around the world. When you join our team of quality professionals, you’ll collaborate on projects on a global scale while being encouraged to grow your skills and discover new career paths with us.

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.

Currently seeking a Senior Regulatory Affairs Specialist. This is a fantastic opportunity to further your regulatory career and develop your expertise in this field.

Duties and Responsibilities:

• Perform global regulatory compliance review of essential documents supporting the start of clinical studies
• Respond to RCR reviewers/submitters on queries on essential documents
• Where required/applicable, facilitate discussion of requirement of deviation to the RCR process with the project teams
• Ensure effective management and coordination of the Regulatory Compliance Review Process
• Maintain knowledge and understanding of PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
• Responsible for tracking RCR approvals
• Point of contact for RCR reviewers
• Responsible for updating and posting of the RCR reviewers list
• Responsible for updating and posting of the RCR Compliance Review forms and posting on the RCR home page
• Assist in development and validation of country-specific review forms for new countries, revision, and validation of existing review forms as necessary
• Assist in the organization of the training of RCR reviewers, when required
• Assist in development and tracking of RCR metrics
• Support the organization of ongoing communication and training amongst the RCR reviewers’ group
• Where required/applicable, assist in project specific RCR processes and training of the RCR reviewers’ group
• Other duties as required

What we offer:

• Learning and development programme, ensuring you reach your potential
• Extensive benefits package based around the health and well- being of our employees
• Competitive salary
• Flexible working culture with work- life balance
• Collaborative and friendly environment
• Global exposure and opportunity to work on international assignments

Accessibility/Disability Access: Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process.

Our 4i Values: Integrity – Innovation – Intensity – Involvement If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Diversity Statement: PPD clinical research services is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD clinical research services is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.

As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.