Sr Manager Regulatory and Clinical Affairs

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information:

The Binding Site Group part of Thermo Fisher Scientific is a global leader in specialty diagnostics. We provide diagnostic assays and instruments to improve the diagnosis and management of blood cancers and immune system disorders. The Binding Sites Freelite offering is widely recommended for multiple myeloma diagnosis and monitoring across all stages of the disease. To learn more visit.

Impactful Work:

The Quality and Regulatory Affairs team at Thermo Fisher Scientific is searching for a Senior Manager Regulatory and Clinical Affairs to develop and execute regulatory strategy and clinical evidence generation plans in partnership with Regulatory Affairs leadership to support product claim expansions and regulatory submissions across the portfolio. This role will be responsible for recommending global regulatory pathways identifying clinical evidence requirements coordinating clinical study planning and execution and ensuring that study outputs support high-quality submissions to regulatory authorities.

Key Responsibilities:

Regulatory Strategy and Submission Leadership

• Develop and execute regulatory strategies for product claim expansions new indications expanded intended use and new market access opportunities in partnership with Regulatory Affairs leadership.
• Recommend appropriate global regulatory pathways submission requirements evidence expectations and agency interaction strategies for assigned programs.
• Translate business priorities and product strategy into actionable regulatory plans including timelines risks assumptions and recommendations for decision points.
• Lead and coordinate preparation of assigned regulatory submissions responses to regulator questions and supporting documentation packages with oversight from Regulatory Affairs leadership as appropriate.
• Assess product claims intended use statements labeling promotional claims and submission content to confirm they are supported by appropriate analytical clinical and scientific evidence.
• Monitor evolving regulatory requirements and guidance relevant to clinical evidence product claims diagnostic performance and market access and communicate potential impact to project teams and leadership.

Clinical Affairs and Evidence Generation

• Develop and execute clinical evidence strategies to support regulatory submissions for product claim expansions New Product Development (NPD) and new market access in partnership with Regulatory Affairs Medical Affairs and Biostatistics stakeholders.
• Develop coordinate and oversee assigned clinical study plans protocols study designs statistical analysis plans clinical performance evaluation strategies and clinical study reports.
• Manage assigned clinical operations resources and external partners to ensure studies are delivered on time within scope and in compliance with applicable regulatory quality ethical and data integrity requirements.
• Coordinate clinical data review monitoring cleaning analysis and interpretation to ensure outputs are submission-ready.
• Collaborate with clinical sites investigators CROs laboratories and internal stakeholders to support effective study startup execution closeout and reporting.
• Confirm clinical study documentation supports regulatory submissions clinical performance claims risk-benefit assessments and post-market obligations.
• Identify clinical evidence gaps and recommend practical strategies to close those gaps.

People and Program Leadership

• Manage coach and develop assigned Regulatory Affairs and Clinical Affairs team members and/or project resources.
• Lead cross-functional project teams responsible for claim expansion and clinical evidence programs.
• Establish clear project plans milestones deliverables owners and escalation pathways.
• Prepare and communicate program status risks decision recommendations and trade-offs to leadership and governance forums.
• Partner with Product Management and commercial stakeholders to evaluate and prioritize claim expansion opportunities based on customer need regulatory feasibility clinical evidence burden cost timeline and business impact.
• Partner with Quality and R&D to ensure regulatory and clinical requirements are integrated into design control change control risk management and validation activities.
• Influence stakeholders across functions and regions to support alignment resolve issues and maintain submission momentum.

Qualifications Education and Experience:

• Bachelors degree in life sciences clinical research regulatory affairs biomedical science medicine or a related field; advanced degree preferred.
• 8 years of experience with in vitro diagnostics laboratory diagnostics companion diagnostics monitoring claims or related diagnostic technologies; 10 years preferred.
• Experience with FDA submissions including 510(k) De Novo PMA supplements Q-Submissions or other regulatory interactions.
• Experience with EU IVDR clinical performance studies performance evaluation reports and/or global IVD regulatory requirements.
• Experience managing or coordinating CROs clinical sites external laboratories investigators or clinical vendors.
• Experience with biostatistics clinical performance evaluation analytical performance risk management and labeling/claims development.

Physical Requirements/Work Environment:

• Office based role with one day hybrid working based on management discretion.
• Ability to travel off-site for audits training workshops and team meetings

Our Mission:

Our mission is to enable our customers to make the world healthier cleaner and safer. Join our team of 100000 colleagues sharing our values of Integrity Intensity Innovation and Involvement. Work with us to accelerate research solve scientific challenges drive innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Equal Opportunity Employer:

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status