Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.  

PPD, the Clinical Research Group of Thermo Fisher Scientific is recruiting for a Regulatory Affairs Specialist with a focus on CMC.

In this role, you primary responsibilities will be to:

Provide high quality client support and interface in terms of the provision of strategic regulatory CMC intelligence, guidance and  regulatory expertise for product development from preclinical through registration and product lifecycle managementAuthor CMC documentation to support regulatory filings e.g. EU IMPDs, simplified IMPDs, US IND Module 3 and Canadian QOSApply in-depth understanding of regulatory guidance and regulations to the preparation of CMC documents and sections for a variety of submissions or other documents, as required.Review CMC documents and ancillary documents and reports for completeness and accuracy and for compliance with regulationsInterface with other regulatory departments within PPD Regulatory Affairs and represent the CMC function on multidisciplinary project teamsPrepare CMC sections of Regulatory Authority scientific advice briefing books e.g. EMA, UK MHRA and US FDACollaborate with project team stakeholders to manage and coordinate the authoring, review, and finalization of CMC documents in accordance with submission timelines, keeping all stakeholders, including clients, informed of progress.Research and utilizes information to ensure high quality and regulatory compliant strategies and submissionsCoordinate the timely and accurate assembly of responses to inquiries from Regulatory Authorities on CMC content of regulatory  submissionsIdentify project issues and contributes to development of alternate strategies as required

Qualifications

Education and Experience Requirements:

Ideally candidates will have a degree (or equivalent)  and higher degree e.g. Chemistry, Biochemistry/Molecular Biology and Pharmaceutical SciencesIdeally, some prior regulatory affairs experience with a CMC backgroundSome knowledge of ICH and other global regulatory guidelinesSome knowledge of CMC Regulatory requirements, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical productsAwareness of the contents of clinical trial applications and marketing authorisation applications, preferredIdeally some prior experience authoring CMC documents to support filings of CTAs and MAAs for NCEs, biopharmaceuticals and Advanced Therapy Medicinal ProductsKnowledge of biopharmaceutical and or pharmaceutical; development, testing or manufacturing preferred.

Knowledge, skills and abilities:

English language (written and spoken) as well as local language where applicableExperienced with Microsoft Office applications, e.g. Word, Excel, Visio, PowerPointMicrosoft Word authoring and formatting skills are essential for this roleEffective oral and written communication skillsGood organizational and planning skillsEffective negotiation skillsAbility to work on own initiative and plan and prioritize work load to meet client deadlinesProven ability to work effectively in a team environmentSome knowledge of global / regional / national country CMC requirements / Regulatory Affairs Procedures for Clinical Trial Authorization, licensing, lifecycle managementGood judgement and decision-making skillsAbility to act as liaison with other departments where necessary (i.e. Project Management, Clinical Supplies, QA, Clinical Management and other Thermo Fisher Business Groups)Some knowledge of budgeting, forecasting and the CRO business model preferredCompetency required in areas of: numeracy, language, analytical, investigative, verbal & written communication, customer interactions‘Right first time’ and ‘Quality Begins with Me’ mindset, attention to detail, multiple project handling, reading and interpretation of data are essential for this role

What we offer:

At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.

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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.