Regulatory Affairs Lead- FSP

Overview

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Work Schedule: Standard (Mon-Fri). Environmental Conditions: Office.

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 Regulatory Affairs Lead position to work for one of our key clients. Our client, a global mid-sized biotech company, focuses on developing innovative treatments for patients with autoimmune diseases. This fast-growing, international organization has a strong scientific foundation. If you are looking for a place where your work, in partnership with others, can have real impact—and where you are encouraged to challenge yourself and contribute to breakthrough solutions, Regulatory Affairs Lead could be a great fit. This is a client-dedicated role for a Regulatory Affairs Lead: 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.

Responsibilities

• Lead regulatory strategy and provide expert regulatory intelligence for multiple countries/projects, supporting product development from preclinical through registration and optimization.
• Prepare client deliverables that meet local, regional and ICH regulatory and technical requirements with expediency and quality; liaise with internal and external clients to market these services.
• Provide senior review of regulatory documents and submissions to ensure high quality standards that meet client expectations and regulatory requirements.
• Act as subject matter expert on regulatory strategy for projects of moderate complexity; keep internal clients informed of up-to-date legislation and guidance.
• Participate in project management activities and coordinate with clients to market regulatory services.
• Provide matrix/project leadership, training and guidance to junior team members on regulations, risk assessment, and project deliverables.
• Support budgeting, forecasting, and adherence to project budgets and timelines.
• Ensure compliance with relevant SOPs and regulatory procedures; contribute to business development activities.

Qualifications

Education and Experience:

• Bachelor's degree or equivalent with relevant formal qualification.
• 8+ years of relevant experience or an equivalent combination of education, training and/or directly related experience.
• Equivalency may be considered in some cases.

Knowledge, Skills and Abilities:

• Excellent English communication skills; local language skills as applicable.
• Strong attention to detail, editorial and proofreading abilities.
• Strong interpersonal skills and ability to work in a multi-disciplinary team; capable of liaising with other departments.
• Proficient in Microsoft Word, Excel, PowerPoint; able to learn new tools.
• Excellent organizational, time management and planning abilities; capable of managing multiple projects and changing priorities.
• Strong negotiation skills and independent judgment to assess sponsor regulatory needs.
• Knowledge of global/regional/national regulatory requirements for clinical trial authorization, lifecycle management, ICH guidelines; experience with EU Clinical Trial Regulation and Clinical Trial Applications (CTA).
• Experience with Global CTAs is advantageous.
• Medical terminology, statistical concepts, and regulatory guidelines knowledge; budgeting and forecasting understanding.
• Ability to perform line management responsibilities.

What we offer

In addition to a competitive salary, we offer an extensive benefits package focused on health and well-being. We promote a flexible working culture and a work-life balance. As a global organization with a local feel, we value diversity and collaboration.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. We invite you to explore 5 reasons to work with us. We are a team of 100,000+ colleagues sharing values of Integrity, Intensity, Innovation and Involvement, working together to accelerate research and support patients in need. StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences and perspectives are valued.

Apply today at

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.

Seniority level

• Not Applicable

Employment type

• Full-time

Job function

• Quality Assurance, Product Management, and Engineering

Industries

• Pharmaceutical Manufacturing and Biotechnology Research

Note: This description is intended to reflect the responsibilities and qualifications for the Regulatory Affairs Lead role. This posting may be adjusted to reflect business needs and regulatory changes.

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