Senior Regulatory Affairs Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Senior Regulatory Affairs Specialist – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to serve as a senior contact in providing innovative solutions, including regulatory expertise. As a Senior Regulatory Affairs Specialist, you'll interact with clients to provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization. You will provide strategic, expedient, and efficient preparation of client deliverables that meet current local, regional, and ICH regulatory and technical requirements. Additionally, you will act as a liaison with internal and external clients in the provision and marketing of these services.

What You’ll Do:
• Prepares and reviews regulatory submissions.
• Provides regulatory strategy and/or technical advice to internal and external clients, and acts as a liaison in executing 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 Requirements:
• 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 5+ years).
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and 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 specialist 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

Working Conditions and Environment:
• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.

Welcome

Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell?

About Us

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Accessibility/Disability Access

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

EEO

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.