Principal Reg Affairs Specialist - Global Support

Work Schedule

Environmental Conditions

Job Description

Summarized Purpose:
Serves as the lead over several countries/projects in providing innovative solutions including regulatoryexpertise and client interface to provide strategic regulatory intelligence and guidance supportingproduct development from preclinical through registration and product optimization. Provides strategicexpedient and efficient preparation of client deliverables that meet current local regional and ICHregulatory and technical requirements. Acts as liaison with internal and external clients in the provisionand marketing of these services

Essential Functions:

• Provides senior review of regulatory documents and submissions created withinor outside of the company in order to ensure high quality standards that meet orexceed client expectations local and regional requirements.
• Acts as subject matter expert in providing regulatory strategy advice to internaland external clients on projects of moderate complexity. Provides internal clientswith up-to-date legislation and guidance as it becomes available.
• Participates in project management activities to support the provision ofregulatory services and acts as liaison with internal and external clients in theprovision of marketing these services.
• Provides matrix/project leadership training and guidance to junior teammembers to support understanding of regulations impact on study assessmentof risk etc. and to achieve a specific goal and/or project deliverables.
• May provide input on peformance reviews to management.
• Ensures adherence to project budgets time schedules and scope of work.
• Ensures compliance with relevant organizational and regulatory SOPs and WPDs.
• Contributes to business development activities including project budgeting/forecasting.

Qualifications:
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 to8 years).
• Global clinical trials experience
• Must have experience working with the FDA Health Canada EU CTR etc.

In some cases an equivalency consisting of a combination of appropriate education trainingand/or directly related experience will be considered sufficient for an individual to meet therequirements of the role.

Knowledge Skills and Abilities:

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

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate receive and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.)