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

India

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

University degree in life sciences or related health sciences (BS/BA/MS or equivalent); degree in Regulatory Affairs advantageous
Minimum of 5 years’ experience in the biotech or pharmaceutical industry, with at least 5 years in Regulatory Affairs CMC
Sound knowledge in life sciences with focus on biological/vaccines/small molecule/gene therapy medicinal products; knowledge of plasma related products advantageous
Strong technical regulatory expertise and understanding of regulatory framework in more than one key region (US, EU, Japan, Switzerland, Australia, China, and Rest of World)
Strong regulatory CMC authoring skills; able to evaluate technical and scientific CMC information for accuracy and compliance with regulatory requirements
Strong knowledge in Good Manufacturing Practice or related areas
Familiarity and ability 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, and problem-solving skills
Strong team player with ability to develop constructive relationships with peers and management
Strong organizational and follow-up skills, attention to detail
Ability to work with minimal supervision based on sound technical and analytical judgment
Flexibility to work in a global cross-cultural environment
Fluent in English and local language

Responsibilities

Authoring and preparation of CMC packages for postapproval lifecycle variation submissions, annual reports, renewals, and responses to HA requests
Perform global change control assessments
Confirm CMC requirements for submissions (e.g., variation, renewal, tender)
Align with clients on technical information to be provided and timelines
Provide packages for internal client review, update as needed, and provide finalized packages for publishing and QC
Update internal systems (RIMS, Publishing, eDMS) or documentation as needed
Support requests for information from HAs or partners
Provide senior review and advice to prepare regional regulatory submissions ensuring high quality standards meeting client expectations and local/regional requirements
Act as subject matter expert providing regulatory strategy advice and technical expertise to internal/external clients for key projects of moderate to high complexity
Provide internal clients with up-to-date legislation and guidance
Ensure quality performance for key/managed projects
Manage project budgeting/forecasting functions
Identify out-of-scope activities in contracts timely and liaise with departments for contract modifications
Collaborate with business development in pricing and securing new business via client presentations, proposal texts, and budgets
Provide matrix/project leadership, training, and guidance to junior team members
Ensure compliance with organizational and regulatory SOPs and WPDs
Participate in launch meetings, review meetings, and project team meetings

Skills

CMC

Regulatory Affairs

Postapproval Variations

Change Control

Regulatory Submissions

HA Responses

RIMS

Publishing

eDMS

Regulatory Strategy

Project Management

Budgeting

Client Presentations

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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