Sr Reg Affairs Spec

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll 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.

Our Regulatory Affairs global team within PPD clinical research services deliver regulatory science services providing regulatory knowledge which accelerates innovation and improves regulatory decision making and helps our customers deliver life-changing therapies to patients faster.

Discover Impactful Work:

Serves as a senior contact in providing innovative solutions including regulatory expertise interacting with clients to provide strategic regulatory intelligence and guidance supporting product development from preclinical through registration and product optimization. Provides strategic expedient and efficient preparation of client deliverables that meet current local regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services.

Key responsibilities:

• Prepares and reviews regulatory submissions.
• Provides regulatory strategy and/or technical advice to internal and external clients and acts as a liaison in implementing strategies.
• Leads the development and implementation of project-specific processes for sponsors.
• Collaborates extensively with other departments regulatory consultants and regulatory authorities.
• Assists in identifying and recognizing 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.
• Provides training and guidance to junior team members as appropriate.
• Participates in project launch meetings review meetings and project team meetings.
• Supports business development activities including project budgeting/forecasting.

Education and Experience:

• Bachelors degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 5 years).

Knowledge Skills Abilities

• Strong English language (written and oral) communication skills as well as local language where applicable
• Solid attention to detail and quality as well as strong editorial/proofreading skills
• Strong interpersonal skills to work effectively in a team environment and act as a liaison with other departments
• Solid computer skills including the use of Microsoft Word Excel Power Point; capable of learning new technologies
• Solid organizational time management and planning skills to create and follow timelines conduct long-range planning adapt to changing priorities and handle multiple projects
• Solid negotiation skills
• Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
• Solid understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization licensing lifecycle management; good knowledge of ICH and other global regulatory guidelines; basic understanding of a regulatory speciality areas such as preclinical clinical CMC publishing etc.
• Solid understanding of medical terminology statistical concepts and guidelines
• Strong analytical investigative and problem-solving skills
• Working knowledge of budgeting and forecasting

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 worlds most urgent health needs submit your application wed 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 100000 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.

Apply today!

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.

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