[Remote] Sr. Manager, Regulatory Affairs Cell and Gene Therapy at Thermo Fisher Scientific

California, United States

Apply Now

Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

N/AIndustries

Requirements

Bachelor’s degree in life sciences, pharmacy, or related field required
Minimum of 8 years related experience in the pharmaceutical or life sciences industry or an advanced degree with 6 years related experience
2-4 years of people management experience strongly preferred
Extensive knowledge of regulatory requirements, including those from the FDA, Health Canada, and other regions, particularly concerning pharmaceutical raw materials and cell and gene therapies
Demonstrated ability to navigate regulatory authorities' requirements and effectively communicate with them
Excellent communication skills
Advanced organizational and time management skills

Responsibilities

Interpret and communicate the impact of relevant global regulations, guidelines, and evolving regulatory trends relating to pharmaceutical product development
Lead maintenance and improvements to regulatory tools, including regulatory information systems
Provide regulatory expertise and support to business leadership
Develop regulatory strategies accounting for global requirements and desired marketing claims
Author and/or review regulatory submissions, specifically device master files, regulatory support files, and meeting requests
Provide regulatory direction to product development teams
Lead all aspects of regulatory compliance of advertising and promotional materials
Supervise compliance with license registration, listing, and renewal requirements
Provide leadership and guidance for the reporting and communicating of product-associated complaints, recalls, market withdrawals, and vigilance reports
Direct the process for evaluating and processing product change requests including impact assessment
Propose innovative regulatory options for new products or claims
Manage departmental budget
Determine work priorities aligned with business, functional, and company goals
Lead a team of regulatory professionals
Communicate a clear plan and motivate the team to achieve goals and defined success metrics

Skills

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

Land your dream remote job 3x faster with AI

Try Jobo Free