[Remote] Senior Manager CMC Regulatory Affairs at Thermo Fisher Scientific

Portugal

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Life SciencesIndustries

Requirements

University degree in life sciences or related health sciences (BS/BA/MS or equivalent, PhD), a degree in Regulatory Affairs is advantageous
8+ years regulatory experience in the pharmaceutical/health care industry
5+ years Regulatory CMC experience
Sound knowledge in life sciences with a focus on biological/vaccines/complex small molecule/gene therapy medicinal products. Experience in plasma related products is an advantage
Strong technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, Switzerland, Australia, China, and Rest of World)
Strong regulatory CMC authoring skills and able to evaluate technical and scientific CMC information for accuracy and compliance with relevant regulatory requirements
Strong knowledge in Good Manufacturing Practice or related areas
Familiar and able to work with RIMS (e.g. Veeva RIMS), eDMS (e.g. Veeva, Documentum) and Change Management (e.g. Trackwise) systems
Microsoft Office skills
Excellent communication, project management, planning, problem solving and presentation skills
Strong team skills

Responsibilities

Leads CMC strategy, authoring, and preparation of postapproval variations, annual reports, renewals, tender applications, and GMP submissions including responses to HA requests
Performs global change control assessments and provide CMC requirements for variations
Align with clients (define information flow) on technical information to be provided and timelines
Oversee and provide packages for internal client review and update these as needed
Oversee and provide finalized packages for publishing and QC published output
Update of internal systems (RIMS, Publishing, eDMS) or documentation as needed
Support requests for information from HAs or from partners
Provides regional lead review and technical advice to prepare regional and/or global regulatory submissions and ensure high quality standards that meet or exceed client expectations, local and regional requirements
Acts as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and oversees key client projects of the highest complexity
Provides internal clients with up-to-date legislation and guidance as it becomes available
Ensures quality performance for key/managed projects
Manages project budgeting/forecasting functions
Identifies and recognizes out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications
Collaborates with business development in pricing and securing new business by making presentations to clients and develops proposal texts and budgets in collaboration with other departments
Provides matrix/project leadership, training, and guidance to junior team members
Ensures compliance with relevant organizational and department SOPs and WPDs
Participates in launch meetings, review meetings and project team meetings. May lead departmental initiatives/project teams

Skills

CMC Regulatory Affairs

Postapproval Variations

Annual Reports

Regulatory Renewals

GMP Submissions

Change Control Assessments

Health Authority Responses

Regulatory Submissions

RIMS

Publishing

eDMS

Global Regulatory Strategy

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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