Principal Reg Affairs Specialist

4 mesi fa

Milano, Italia Thermo Fisher Scientific A tempo pieno

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.Our Global Regulatory Affairs team is expanding We are looking for a Principal Regulatory Affairs Specialist position to work for one of our key clients.

This a client dedicated role for a Regulatory Affairs Sr Specialist role: clinical expert role to support clinical trial new indications, including the early indications, early development and late development, and that can support later development. Global experience is a plus, EU CTR experience will be important.

The Principal Reg Affairs Specialist will act as the lead over several countries/projects in providing innovative solutions including regulatory expertise and client interface to provide strategic regulatory intelligence, and guidance supporting product development from preclinical through registration and product optimization. They will provide strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. They will also act as liaison with internal and external clients in the provision and marketing of these services.

Essential Functions:

- Provides senior review of regulatory documents and submissions created within or outside of the company in order to ensure high quality standards that meet or exceed client expectations, local and regional requirements.
- Participates in project management activities to support the provision of regulatory services, and acts as liaison with internal and external clients in the provision of marketing these services.
- Provides matrix/project leadership, training and guidance to junior team members to support understanding of regulations, impact on study, assessment of risk, etc., and to achieve a specific goal and/or project deliverables.
- May provide input on performance 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:

- 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 8+ 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:

- Excellent English language (written and oral) communication skills as well as local language where applicable
- 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 other departments
- Strong 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
- Strong 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
- Strong understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; good understanding of a regulatory speciality areas, clinical, in particular Clinical Trial Applications (CTA) including proven experience in submissions according to EU Clinical Trial Regulation.
- Experience in Global CTAs would be an advantage.
- Strong understanding of medical terminology, statistical concepts, and guidelines
- Excellent analytical, investigative and problem-solving skills
- Solid understanding of budgeting and forecasting

**What we offer**:
As well as being rewarded a competitive salary, we have an extensive benefits package based around the hea

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