Global Reg Affairs Lead (Reg Affairs AD) – FSP

Job title:

Global Reg Affairs Lead (Reg Affairs AD) – FSP

Company

Thermo Fisher Scientific

Job description

Work ScheduleEnvironmental ConditionsJob DescriptionAt 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.This a client dedicated role for a Regulatory Lead role: strategic role to support indications, including the early indications, early development and late development, and that can support later development (eg.: Phase 2 to BLA). Global experience is a must as that reflects the nature of our client developments.Essential Functions:

• Provides regional lead review and technical advice to prepare regional and/or global regulatory submissions and ensure high quality standards that meet or exceed client expectations, local and regional requirements.
• Acts as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and oversees key client projects of the highest complexity. Provides internal clients with up-to-date legislation and guidance as it becomes available.
• Ensures quality performance for key/managed projects.
• Manages project budgeting/forecasting functions.
• Identifies and recognizes 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.
• Major involvement in reviewing Protocol and ICF with a critical mindset
• Point of contact for Health Authorities and internal stakeholders like business and marketing
• Main responsible for Response to Questions from Health Authorities
• Collaborates with business development in pricing and securing new business by making presentations to clients, and develops proposal texts and budgets in collaboration with other departments.
• Provides matrix/project leadership, training and guidance to junior team members.
• Oversee and interact with the RALs working for the development program
• Ensures compliance with relevant organizational and department SOPs and WPDs.
• Participates in launch meetings, review meetings and project team meetings.
• May lead departmental initiatives/project teams.

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 10+ 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:

• Advanced 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; in-depth understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc.
• Outstanding English language (written and oral) communication skills as well as local language where applicable
• Although the role is expected to be performed in EU, US IND experience is expected
• Experience in CTA but also in procedures like PIP, ODD and initial MAA
• Regulatory strategy for all the above procedures
• Exceptional attention to detail and quality as well as outstanding editorial/proofreading skills
• Outstanding interpersonal skills to work effectively in a team environment and act as a liaison with other departments
• Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
• Superb organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
• First-rate 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
• Advanced understanding of medical terminology, statistical concepts, and guidelines
• Outstanding analytical, investigative and problem-solving skills
• Excellent understanding of budgeting and forecasting
• Strong executive presence and consultation and presentation skills

Management Role:No people management responsibilityWhat we offer:At PPD Clinical Research Services we hire the best, develop ourselves and each other, and recognise 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 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 organisation 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.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.#LI-AS3

Expected salary

Location

België

Job date

Tue, 03 Dec 2024 23:46:47 GMT

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