[Remote] Associate Director 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

Biotechnology, Pharmaceuticals, Life SciencesIndustries

Requirements

Expertise in CMC regulatory affairs, particularly postapproval lifecycle management for global marketed products
Knowledge of global regulatory landscapes (US, EU, Japan, Switzerland, Australia, China, Rest of World)
Experience with change control strategies, postapproval variation submissions, annual reports, renewals, tender applications, site registrations, and HA responses
Proficiency in regulatory systems (RIMS, Trackwise, Publishing, eDMS)
Management experience, including staff interviewing, selection, development, performance management, coaching, salary administration, hiring, corrective action, terminations, time/expense approvals
Ability to provide regulatory consulting and strategic advice to clients
Skills in project management, budgeting, forecasting, resource allocation, and contract negotiations
Experience in business development, bid proposals, client presentations, and securing new business
Knowledge of compliance with SOPs, WPDs, ethical, and regulatory standards

Responsibilities

Lead CMC postapproval lifecycle management activities for global marketed products
Oversee and review global change control strategy (for US, EU, Japan, Switzerland, Australia, China, and Rest of World)
Develop, oversee, and review CMC strategy and preparation for postapproval variation submissions, strategy and annual reports, renewals, tender applications, site registrations, including responses to HA requests
Align with clients on technical information to be provided and timelines; define information flow
Coordinate packages for internal client review and update as needed
Oversee delivery of CMC packages for publishing and QC published output
Oversee and/or update internal systems (RIMS, Trackwise, Publishing, eDMS) or documentation as needed
Support requests for information from HAs or partners
Manage staff, including interviewing/selection, job description preparation, professional development, goal setting, performance management, coaching/mentoring, counseling, separations, salary administration, hiring, corrective action, terminations, time/expense approvals; promote EEO and Affirmative Action
Provide regulatory consulting and strategic advice to internal/external clients; serve as executive contact for key clients, attend HA meetings and PR functions; ensure quality performance
Manage project budgeting/forecasting, resource shifting, participate/lead project meetings
Identify out-of-scope activities in contracts timely and liaise for modifications
Collaborate with business development/senior management on pricing, presentations, bid proposals, budgets, contract negotiations
Contribute to development/implementation of global/regional function/plans
Ensure compliance with organizational/department SOPs and WPDs
Create/lead development/implementation of processes/procedures to increase productivity/accuracy; develop/implement systems/tools for efficiency, process improvements, cycle time reduction, submission activities, metrics

Skills

CMC Regulatory Affairs

Postapproval Lifecycle Management

Change Control Strategy

Postapproval Variations

Regulatory Submissions

HA Responses

RIMS

Trackwise

Publishing

eDMS

Staff Management

Performance Management

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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