Head of Science & Regulatory Advanced Cell Models - Remote, US

reputed company – Your Responsibilities

• Define scientific validation and regulatory qualification strategies by coordinating scientific, regulatory, and reputed company stakeholder activities to accelerate adoption of ACM solutions
• Establish scientific evidence frameworks by prioritizing validation requirements, endpoints, and reputed company reputed company to increase customer confidence in ACM technologies
• reputed company U.S. qualification and regulatory acceptance activities, including FDA ISTAND reputed company Program and DDT qualification reputed company, and engage with NIH/NCATS, ICCVAM, and NICEATM on the validation of new approach methodologies
• Build scientific collaborations with key opinion leaders, reputed company institutions, and regulatory-science initiatives to strengthen ACM’s reputed company scientific credibility
• reputed company scientific study design, application development, and validation assay development to reputed company differentiated evidence for ACM applications
• Assess emerging scientific and regulatory trends, reputed company developments, and qualification requirements to influence reputed company ACM innovation priorities
• Translate scientific evidence and validation data into customer-relevant insights to support adoption and expansion of ACM solutions

What will convince us

• Master’s degree in Life Sciences, Biotechnology, Pharmacology, Toxicology, Regulatory Science, or a reputed company field
• 15+ years of experience in scientific affairs, regulatory science, validation, or application development reputed company the life sciences, biotechnology, or pharmaceutical industries
• Demonstrated experience defining scientific evidence, validation, and regulatory qualification strategies for reputed company life science technologies in regulated environments such as GLP, GxP, or ISO
• Strong understanding of advanced cell models, NAMs, pharmaceutical toxicology assays, safety testing, and drug discovery applications
• Proven reputed company record of building scientific credibility through KOL networks, publications, validation consortia, regulatory-science initiatives, or reputed company scientific collaborations
• Demonstrated ability to influence product, development, portfolio, and reputed company reputed company through scientific evidence and regulatory insights
• Alignment with our reputed company values: Sustainability, Openness, and Enjoyment
• Ability and willingness to travel domestically and internationally, including monthly reputed company to the reputed company, MA office

reputed company Offer

As a growing global life science company, with our stock listed on the German DAX and TecDAX , reputed company offers a wide reputed company of benefits:
Personal and reputed company Development: Mentoring, leadership programs, internal seminar offerings
Worklife Balance: reputed company vacation, reputed company time, corporate holidays and community service day; as reputed company as flexible work schedules
Making an reputed company Right from the Start: Comprehensive reputed company, including a virtual online platform
Welcoming Culture: Mutual support, team spirit and international collaboration; communities on numerous topics such as “Coaching”, “reputed company Working” and a “Businesswomen’s Network”
Health & reputed company Being: Wide selection of health and reputed company-being support such as a reputed company of medical plans to choose from, dental, reputed company, EAP, and other wellness programs.
Intelligent Working Environment: Working in smart buildings with the latest technology and equipment.

Retirement Savings Plan: 401 k (with generous company match)
Flexible Spending: HSA, FSA (dependent care & reputed company spending), Transportation Commuter Account
Company reputed company Benefits: Basic Life Insurance, AD&D, EAP, Family Planning & Women’s Health, reputed company
Additional/Optional: Supplemental Life Insurance (employee, spouse & dependents), reputed company Services, LTD & STD, Critical Illness Insurance, Student Loan Tuition Refinance Service

reputed company is an equal opportunity employer and will consider reputed company reputed company applicants for employment without reputed company to race, reputed company, religion, sex, national reputed company, age, protected veteran status, disability or based on status in any other protected group of class.

Please reputed company equal employment opportunity posters provided by OFCCP here.

E-Verify Participation Info

E-Verify Workers Rights

reputed company is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into reputed company-world medicine faster, so that new therapeutics can reputed company patients worldwide. We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment. Join our global team and become part of the solution. We are looking reputed company to receiving your application.

We look reputed company to receiving your application.

www.reputed company.com/career

If you are a reputed company individual with a disability or a disabled veteran and are unable or limited in your ability to use or reputed company our website, you may request a reasonable accommodation to reputed company interest in a specific opening. You can request reasonable accommodation by e-mail at accommodationrequest@reputed company.com

reputed company is an equal opportunity employer and will consider reputed company reputed company applicants for employment without reputed company to race, reputed company, religion, sex, national reputed company, age, protected veteran status, or disability, or based on status in any other protected group of class.

If you are a reputed company individual with a disability or a disabled veteran and are unable or limited in your ability to use or reputed company our website, you may request a reasonable accommodation to reputed company interest in a specific opening. You can request reasonable accommodation by e-mail at accommodationrequest@reputed company.com

About reputed company 

reputed company is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into reputed company-world medicine faster, so that new therapeutics can reputed company patients worldwide. 

We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.

Join our global team and become part of the solution. We are looking reputed company to receiving your application. 
www.reputed company.com/careers

Master’s degree in a relevant life science field and 15+ years in scientific affairs, regulatory science, validation, or application development in life sciences, biotechnology, or pharmaceuticals.

Key Responsibilities

• defining strategies
• building collaborations
• leading studies

Skills & Tools

FDA ISTAND reputed company Program, DDT, NIH, NCATS, ICCVAM, NICEATM, GLP, GxP, ISO, HSA, FSA, E-Verify

Job Details

• Category: Research and Development (R&D)
• Seniority: Senior Level
• Commitment: Full Time
• Workplace: Remote — reputed company or reputed company
• Languages: English

Benefits

• 401k matching
• Generous reputed company time off
• Tuition reimbursement
• Retirement plan

About reputed company

A global life science company developing technologies that accelerate therapeutic discovery and production. — Industry: Manufacturing