[Remote] Specialist CMC Regulatory Affairs at Thermo Fisher Scientific

Portugal

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalIndustries

Requirements

University degree or equivalent experience in life sciences or related health sciences (BS/BA/MS or comparable)
Degree or equivalent experience in Regulatory Affairs is beneficial
At least 2 years of experience in the biotech or pharmaceutical sector, with a minimum of 2 years specifically in Regulatory Affairs CMC
Experience in life sciences, particularly in biological, vaccines, small molecule, or gene therapy medicinal products, is beneficial
Proven regulatory CMC authoring skills with the ability to evaluate technical and scientific CMC information for accuracy and compliance
Familiarity with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva, Documentum), and Change Management (e.g., Trackwise) systems
Proficiency in Microsoft Office
Excellent communication, project management, planning, and problem-solving skills
Strong teammate with a demonstrated ability to develop constructive and effective relationships with peers and management
Outstanding organizational and follow-up skills, with strong attention to detail
Ability to work independently with sound technical and analytical judgment
Flexibility to thrive in a global cross-cultural work environment
Proficient in English and the local language

Responsibilities

Author and prepare global CMC variation submissions, annual reports and renewals, tender applications, and GMP submissions
Comply strictly with client’s technical information requirements and timelines
Provide packages for internal client review, update as needed, and deliver finalized packages for publishing and QC
Update internal systems (RIMS, Publishing, eDMS) or documentation as required
Support requests for information from Health Authorities or partners
Work closely with other departments, regulatory consultants, and regulatory authorities
Identify and acknowledge out-of-scope activities in contracts promptly and coordinate with other departments to effectively carry out contract modifications

Skills

CMC Regulatory Affairs

Regulatory Submissions

Variation Submissions

Annual Reports

GMP Submissions

RIMS

Veeva RIMS

eDMS

Veeva

Documentum

Trackwise

Change Management

Microsoft Office

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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