Life Science Label Coordinator Job at Beacon Hill (Waltham)

Global Labeling Operations Senior Regulatory Affairs Associate

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

Mexico , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University degree in Life Sciences, Chemistry, Engineering, or related pharmaceutical field
advanced degree (MSc, PhD, PharmD) preferred
Fluency in English (verbal and written)
additional languages a plus
Minimum 3 years of biotech/pharma industry experience, including 2+ years in labeling/regulatory operations
Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management
Experience with flu campaigns, pandemic products, and direct-to-consumer advertising
Familiarity with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, Trackwise, and other regulatory systems
Proficiency in Microsoft Office, SharePoint, Adobe Acrobat, TVT, PromoMats, GLAMS
Deep understanding of regulatory requirements for drug development, global labeling, and post-marketing

Job Responsibility

Manager internal global labeling and drug safety activities and coordinate bi-weekly updates
Coordinate readability testing (planning, team review, and communications)
Oversee translations for foundational markets (EU, CH, DE)
Coordinate and upload CH labels to AIPS
submit approved labels to external platforms (HA, ePIL)
Upload approved labels to internal systems (Documentum, Weblabel, intranet)
Manage linguistic reviews and dispatch CCDS, foundational labels, and multi-market manuscripts to stakeholders
Perform data entry in Trackwise/Veeva and prepare annual labeling reports
Review and update submission content plans
prepare change control documentation for CCDS-driven changes

What we offer

Competitive compensation, benefits, and opportunities for career growth
Flexible work arrangements
Supportive and inclusive environment
Opportunities for career growth
Diverse and global client exposure
Learn from experts

New

Regulatory Affairs Labelling Manager

Accountable for end‑to‑end execution of compliant, accurate, and timely local pr...

Location

Egypt , Cairo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Pharmacy or related life sciences (required)
advanced degree is an advantage
Typically 4–8+ years of Regulatory Affairs experience with strong hands‑on labeling and artwork/packaging lifecycle management
Current or previous experience within MNCs is a must
Knowledge of Middle East & Africa regulatory requirements and practical experience coordinating multi‑country implementations
Language skills: English (required)
French literacy strongly preferred
Arabic preferred when the role includes Arabic translation review responsibilities
Demonstrated proficiency working in regulated document and workflow systems (e.g., Veeva Vault, RIM tools) and in cross‑functional matrix environments
Skills/behaviors: detail orientation, planning/priority management, proactive risk management, clear written/oral communication, cultural awareness, and a quality mindset

Job Responsibility

Own and execute local labeling activities for assigned products/country clusters (e.g., SmPC/PI, PIL/leaflet, carton/label text, IFU), ensuring content accuracy, completeness, and compliance
Translate global core updates into local implementation plans: perform impact assessments, draft/redline local texts, coordinate review/approval, and support submission strategy for labeling variations/line extensions
Act as local/regional source text owner for artwork creation: deliver ‘right‑first‑time’ source texts and maintain traceability from CDS/CCDS/GCL changes to country label implementation
Coordinate packaging and artwork lifecycle activities (leaflet, label, blister, outer pack): initiate and manage updates, support shared pack/SKU strategy execution, and ensure supply‑readiness timelines are met
Manage translation workflows (including engaging translation agency systems): request translations, track readiness, and perform 100% translation review for both content and format (as required for regional languages)
Execute labeling/artwork review and approval tasks in designated systems (e.g., Veeva Vault, RIM/Regulatory Information Management, artwork management tools), maintaining version control and inspection‑ready documentation
Monitor and report operational metrics (e.g., right‑first‑time labels, cycle time, on‑time delivery) and drive corrective actions for recurring defects or bottlenecks
Support biosimilars labeling redaction/maintenance activities (as applicable to assigned portfolio)
Support track‑and‑trace/serialization intelligence gathering and execution for assigned clusters
ensure packaging/labeling requirements are reflected in artworks and implementation plans

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Senior Manager, Hub Labeling

Is responsible for executing the content management of LPDs, LLDs and PLDs for n...

Location

Australia , Sydney

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Life sciences, pharmacy graduate or equivalent
or equivalent relevant professional experience
Advanced academic qualifications/degree such as PhD
Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations
Demonstration of attention to detail and problem-solving skills
Proven technical aptitude and ability to quickly learn new software
Proven technical aptitude and ability to quickly learn regulations and standards
‘Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs
preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous especially with the perspective of the implications of a Core Data Sheet on LPDs
Ability to understand, assess and manage the regulatory implications of product strategy with regard to the product label

Job Responsibility

Is responsible for executing the content management of LPDs, LLDs and PLDs for nationally registered products for their assigned products across multiple countries/regions
Acts as a subject matter expert for local labeling throughout the organisation, leading or assisting in the most complex labeling projects or initiatives, and contributing to the use and development of current and new tools, technologies and processes to support global label development, submission and approval
Sharing of intelligence and contribution to knowledge resources is also a key part of the role
The Senior Manager is proactive in gathering, assessing and disseminating regulatory intelligence for use by the labeling managers as well as for use in strategic decision-making at the global group level
The Senior Manager will insightfully seek technology solutions leveraging process automation and Artificial Intelligence (AI)
May lead/manage projects
May supervise/lead colleagues/teams
May act as delegate/deputy for the TLs
To utilize regulatory labeling expertise to review, develop and deliver labeling documents for submission to the Regulatory Authorities across markets/regions, requesting medical advice and input from other functions as appropriate
To support provision of other deliverables within the scope of ILG responsibilities e.g. readability testing

What we offer

Paid parental leave
Access to Health & Wellness apps
Career Growth Experiences program
Recognition & rewards program
Paid volunteer days
Life Insurance Benefits
Pfizer Learning Academy access to top content providers
Access to flu vaccines & skin checks
Options to purchase additional leave
Salary packaging & novated lease options

Fulltime

Non-Pharma Global Regulatory Affairs Specialist

The Global Regulatory Non-Pharma Specialist manages regulatory documentation and...

Location

Italy , Bologna

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

At least 5 years’ experience in Regulatory Affairs preferably within the food supplements, medical devices, and cosmetics sectors
Exposure to regulatory operations or documentation in EU and/or RoW markets or similar experiences is preferred
Advance degree in Life Sciences, Pharmacy, Chemistry, or a related field
Relevant certifications in Regulatory Affairs are considered a plus
Good knowledge of EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong attention to detail, time management and organizational skills
Willingness to learn and ability to work effectively in a team-based environment
Strong communication and interpersonal skills
Proficiency in Microsoft Office Suite and familiarity with document management systems
Fluent in English, both written and spoken

Job Responsibility

Contributing in a cross-functional team to provide the necessary regulatory input for the development of new projects
Support regulatory strategies by providing impact assessments
Collaborate actively with the Research & Development team to integrate regulatory requirements during the design and development of assigned products
Prepare, organize and submit regulatory documentation for submission and maintenance of dossiers for the projects assigned
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Manage multiple tasks in a fast-paced environment while keeping on task and to the company’s quality standards
Contribute to the preparation of regulatory project updates in internal meeting and governance committee providing regulatory input and flagging risks
Assist colleagues with administrative tasks
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Review and validate commercial artwork, packaging, and labeling in compliance with EU Regulations, ensuring timely product launches

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Process Technologist

An exciting opportunity has arisen for a Process Technologist to join a fast-pac...

Location

United Kingdom , Somerset

Salary:

38000.00 - 40000.00 GBP / Year

Zest Food Jobs

Expiration Date

Until further notice

Requirements

BSc in Food Science/Technology (or similar)
2+ years' NPD/process experience within FMCG
Strong knowledge of UK labelling legislation
Enjoys working in a fast-paced environment, both independently and as part of a team, with a hands-on approach
Excellent organisational and communication skills
A valid driving licence

Job Responsibility

Managing product development from concept to launch, ensuring customer and legislative requirements are met
Building and maintaining strong relationships with manufacturers and supporting product trials across the UK and Ireland
Coordinating samples, labelling, documentation, and shelf-life evaluations
Assisting with customer visits, including preparing product displays and providing on-site support
Identifying innovative ideas and ingredient opportunities to support continuous improvement
Monitoring food trends and competitor activity to share insights with the wider team

What we offer

Package

Fulltime

Senior Regulatory Affairs Consultant - Labelling

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

United Kingdom , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University degree in a life science discipline
Strong knowledge of EU regulatory requirements for product labelling and promotional materials
Experience with electronic content management systems and regulatory SOPs
Excellent project management and organizational abilities
Outstanding written and verbal communication skills
Proven ability to work effectively in cross-functional teams
Fluent in English, written and spoken

Job Responsibility

Create, update and maintain EU Product Information in line with CCDS, Agency RTQ, and current labelling requirements
Serve as the key point of contact for EU Product Information for both internal and external stakeholders
Lead reviews, round tables, and approvals for EU Product Information in appropriate systems according to SOPs
Deliver competitive labelling searches and contribute to TLP for early development assets
Ensure timely tracking and management of all EU Product Information in appropriate systems
Lead Readability Testing processes including vendor selection, agreement management, questionnaire review, and submission of final reports
Coordinate Linguistic Review processes with LR Coordinator according to SOPs
Communicate proactively with the Artworks team for artwork and mock-up changes, participating in Change Control Processes
Lead the Local Labelling Committee for creation, review and approval of EU Product Information
Serve on the EU Clearance Committee as primary regulatory reviewer for promotional materials

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

Senior Regulatory Affairs Associate - France Local Regulatory Responsible Person

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

France , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University degree in a life science discipline
Minimum 5 years' experience in French Regulatory Affairs, with strong understanding of French and EU regulatory requirements
Proven experience with multiple submission types: CP, MRP, DCP, and National procedures
Comprehensive lifecycle management expertise for French submissions
Experience with ANSM submission processes and requirements
Competence in labelling management (updates, mock-up review, and print release processes)
Medical device knowledge advantageous, but not essential
Familiarity with systems such as Veeva Vault
Excellent organizational, time management, and interpersonal skills in a global environment
Proven ability to work effectively both independently and in teams

Job Responsibility

Provide local inputs to develop and execute innovative regulatory strategies for new product registrations and lifecycle management activities
Ensure strict compliance with local regulations and actively participate in policy activities with industry groups and trade associations
Act as RA representative in audits/inspections, ensuring readiness and timely CAPA closure
Monitor regulatory landscape changes and communicate requirements to Global Regulatory Affairs (GRA) and local teams
Serve as primary interface with ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé), industry groups, and trade associations
Lead in-country regulatory processes for licenses, partner regulatory licenses, and market access collaborations
Prepare and coordinate local-specific documentation (e.g., Module 1) to meet national submission requirements
Monitor status of submitted regulatory activities and ensure timely completion
Manage comprehensive lifecycle activities including variations, renewals, PSURs, and PIP submissions
Ensure timely submission of renewals and mandated post-approval applications

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

Senior Regulatory Affairs Associate - Spain Local Regulatory Responsible Person

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

Spain , Madrid

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University degree in a life science discipline
Minimum 5 years' experience in Spanish Regulatory Affairs, with strong understanding of Spanish and EU regulatory requirements
Proven experience with multiple submission types: CP, MRP, DCP, and National procedures
Comprehensive lifecycle management expertise for Spanish submissions
Experience with AEMPS submission processes and requirements
Competence in labelling management (updates, mock-up review, and print release processes)
Medical device knowledge advantageous, but not essential
Familiarity with systems such as Veeva Vault
Excellent organizational, time management, and interpersonal skills in a global environment
Proven ability to work effectively both independently and in teams

Job Responsibility

Provide local inputs to develop and execute innovative regulatory strategies for new product registrations and lifecycle management activities
Ensure strict compliance with local regulations and actively participate in policy activities with industry groups and trade associations
Act as RA representative in audits/inspections, ensuring readiness and timely CAPA closure
Monitor regulatory landscape changes and communicate requirements to Global Regulatory Affairs (GRA) and local teams
Serve as primary interface with AEMPS (Agencia Española de Medicamentos y Productos Sanitarios), industry groups, and trade associations
Lead in-country regulatory processes for licenses, partner regulatory licenses, and market access collaborations
Prepare and coordinate local-specific documentation (e.g., Module 1) to meet national submission requirements
Monitor status of submitted regulatory activities and ensure timely completion
Manage comprehensive lifecycle activities including variations, renewals, PSURs, and PIP submissions
Ensure timely submission of renewals and mandated post-approval applications

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

Life Science Label Coordinator

Beacon Hill

Location:
United States , Waltham

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
March 22, 2026

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