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

California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

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, and their influence on the product development process
Ability to evaluate and analyze potential regulatory impact on new and existing products and provide strategic recommendations to minimize risks and ensure compliance
Extensive experience in compiling and submitting regulatory filings with a track record of leading successful complex regulatory filings in relation to cell and gene therapies
Demonstrated ability to navigate regulatory authorities' requirements and effectively communicate with them to ensure timely and accurate submissions
Excellent communication skills to effectively interact with internal customers, regulatory authorities, and cross-functional teams
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 in the area of cell and gene therapy
Lead maintenance and improvements to regulatory tools, including regulatory information systems to meet organizational objectives
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 to FDA and other regulatory bodies
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 as applicable
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

Key technologies and capabilities for this role

Regulatory AffairsCell and Gene TherapyGlobal RegulationsFDA SubmissionsDevice Master FilesRegulatory StrategiesRegulatory Information Systems

Questions & Answers

Common questions about this position

What education and experience are required for this role?

A Bachelor’s degree in life sciences, pharmacy, or related field is required, along with a minimum of 8 years related experience in the pharmaceutical or life sciences industry, or an advanced degree with 6 years related experience. Additionally, 2-4 years of people management experience is needed.

Is this position remote or office-based?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What does the team structure look like for this position?

The role involves leading a team of regulatory professionals, providing guidance and support, and managing departmental budget and work priorities.

What makes a strong candidate for this Sr. Manager role?

Strong candidates will have expertise in interpreting global regulations for cell and gene therapy, experience leading regulatory teams, and skills in developing strategies, authoring submissions, and ensuring compliance in pharmaceutical product development.

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.

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