Regulatory Affairs Labelling Manager Job at Proclinical (Hertfordshire)

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

Quality Compliance Senior Manager - Labelling & Regulatory Affairs

Location

United Kingdom , Cambridge; Uxbridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Experience in Quality Management, Quality Compliance or other relevant risk-based quality practices in the pharmaceutical/biotech industry and thorough knowledge of R&D processes and operations
Thorough knowledge and application of international requirements of Good Pharmacovigilance Practice (GPvP) & Regulatory Affairs
Previous experience supporting regulatory authority inspections of pharmacovigilance activities
Experience of leading and/or supporting process improvement initiatives
Previous leadership or mentoring experience is ideal

Job Responsibility

Act as the Quality Lead contact for Labelling & Regulatory Affairs activities within R&D Quality
Ensure proactive identification of issues relating to processes, programs, and external relationships, escalate issues to appropriate compliance/quality oversight bodies and participate in compliance investigations, management, and remediation
Assess and manage risks including providing input into the development of the annual GPvP audit plan
Participate as the Quality representative for evaluating and providing oversight of Labelling and Regulatory Affairs vendors/service providers
Prepare, analyze, and communicate compliance metrics (e.g., deviation, audit and inspection data) and other significant compliance information
Represent R&D Quality during governance and management review meetings that involve Labelling and Regulatory Affairs
Maintain knowledge of current regulatory and compliance practices/issues, assess changes in regulations and the external environment, and advise customers
Support inspections and external audits, including preparing, conducting, and closing out response reviews
Provide support for audit planning meetings, debriefs, audit plan outlines and response reviews
Develop long-term remediations and process improvements through Root Cause Analysis (RCA)

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
Ability to work flexibly from home with occasional office work

Fulltime

Regulatory Affairs Manager

In this vital role you will work to ensure that Amgen acquires and maintains all...

Location

United Kingdom , Uxbridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Scientific Degree and demonstrated experience in a similar role
Regulatory principles
Working with policies, procedures and SOP’s
Knowledge of legislation and regulations relating to medicinal products
Awareness of the registration procedures in region for clinical trials, MA, post approval changes, extensions and renewals
Knowledge of drug development
Knowledge of and experience in regional regulatory environment
Strong communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to anticipate and prevent potential issues

Job Responsibility

Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements
Under general supervision, implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements
Provide content guidance for regional regulatory documents and meetings in accordance with global strategy
Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans)
Support regional label negotiation activities
Under general supervision participate in the development, and execution of regional regulatory product strategies
Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies
Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products
Perform regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement
Under supervision evaluate and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labelling

What we offer

Growth 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

Fulltime

Senior Manager Regulatory Affairs CZ&SK

Senior Manager Regulatory Affairs CZ&SK. Czech Republic - Prague. SALARY RANGE: ...

Location

Czech Republic , Prague

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree and 8 years of directly related experience
Degree and in-depth regulatory experience and/or related to the affiliate
Depth knowledge of affiliate legislation and regulations relating to medicinal products
English and Czech and/or Slovak language working proficiency
Good negotiation and Influencing skills
Ability to anticipate and prevent potential issues
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
Cultural awareness and sensitivity to achieve results across both regional, affiliate and international borders
Ability to manage multiple activities and set priorities
Ability to lead teams and develop effective teams

Job Responsibility

Provides affiliate regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules
Oversee the affiliate and manage a regulatory team to ensure delivery of assigned local and ELMAC Regulatory initiatives
First point of contact for interactions with local regulatory agency(ies)
Ensure that the local Regulatory staff delivers assigned local and ELMAC Regulatory initiatives across the affiliates
Represent Regulatory on the affiliate leadership team
Provide local regulatory input to support development and execution of assigned Regulatory Affairs initiatives and effective interactions with key regulatory agency(ies)
Supervise and oversight for one or more regulatory staff
Manage and liaising with distributors (if applicable)
Translates assigned global, regional and ELMAC Regulatory initiatives into local regulatory objectives where applicable
Acts as senior point of contact for local regulatory advice on commercial and medical activities within the affiliate

Fulltime

Nordic Regulatory Affairs Manager

Location

Sweden , Stockholm

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

University degree in Life Sciences or a related field
5+ years of Regulatory Affairs experience within Pharmaceuticals
exposure to other product categories is a plus
Strong knowledge of Nordic regulatory frameworks (experience with Norwegian regulations is an advantage)
Experience with artwork, labeling, and regulatory systems (e.g., Veeva RIM)
Proven ability to work cross-functionally in fast-paced, international environments and interact with regulatory authorities
Fluent in Swedish and English
Strong communication skills with a proactive, solutions-oriented and commercially minded approach
Structured, independent, and collaborative, with the ability to prioritize and drive work in a dynamic setting

Job Responsibility

Drive end-to-end regulatory activities across product classifications, ensuring timely submissions and approvals
Manage lifecycle activities for pharmaceutical products
Lead communication with regulatory authorities and relevant bodies
Review artworks and commercial materials to ensure compliance
Provide strategic regulatory input to enable product launches and market access
Support local implementation of global NPD, EPD, and GeoX projects
Perform pragmatic risk assessments balancing compliance with business needs
Ensure accurate and compliant data in Veeva RIM and artwork systems
Secure compliant product information, translations, and labeling
Maintain national databases and product information platforms

What we offer

Opportunity to create, grow, and encourage
Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
Flexible schedule, hybrid model with the primary work place in the office, and life-work balance
Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
Very positive work environment in a dynamic, international, and motivated team
Start-up spirit while being a part of the large international organization with strong values

Fulltime

Manager, Regulatory Affairs & Quality Assurance

NYES is seeking an accountable and specialized Manager of Regulatory Affairs & Q...

Location

United States , Brooklyn

Salary:

Not provided

New York Embroidery Studio

Expiration Date

Until further notice

Requirements

5–10 years of specific experience in Regulatory Affairs for PPE manufacturing, with a proven track record of successful FDA clearances
Comprehensive knowledge of FDA Class I and II medical device classifications, ASTM testing methods, and NIOSH approval standards
Strong background in implementing and maintaining Quality Management Systems (QMS) compliant with federal standards (21 CFR 820) and international standards (ISO 13485)
RAPS (Regulatory Affairs Certification) and Six Sigma Black Belt (preferred)
A professional who seeks full accountability and can coordinate complex, cross-functional teams to achieve compliance goals

Job Responsibility

Serve as the primary lead for the development, implementation, and continuous improvement of the ISO 13485 Quality Management System, ensuring all manufacturing and quality processes maintain international certification
Lead the preparation and submission of FDA 510(k) premarket notifications for medical-grade PPE (e.g., surgical masks, isolation gowns, etc.) to ensure products are “FDA-cleared.”
Oversee adherence to 21 CFR Part 820 (Quality System Regulation) for all PPE manufacturing processes and controls
Manage the certification and approval process with NIOSH for respiratory protective devices, such as N95 respirators
Ensure materials meet rigorous ASTM International standards for barrier performance, including fluid resistance (ASTM F903) and viral penetration (ASTM F1671)
Act as the primary point of contact for government agencies, ensuring manufacturing and marketing practices align with OSHA requirements
Direct the development of labeling and packaging to ensure accurate regulatory claims and prevent the marketing of unverified equipment
Partner with product development and commercial teams to navigate registration processes and ensure timely product launches

Associate Regulatory Affairs Manager

To hold the Pharmacist Poison License Type A for the company to operate in Malay...

Location

Malaysia , Petaling Jaya

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

Minimum 5 years of regulatory experience in a pharmaceutical environment with experience in pharmaceutical product artwork management
To have experienced working in a controlled regulatory environment and making sure that the company is fully compliant with the following Acts & Regulations: Sale of Drugs Act, 1952
Control of Drugs & Cosmetics Regulations, 1984
Dangerous Drugs Act, 1952
Medicines (Advertisement & Sale) Act, 1956
Patents Act, 1983
and any other related Acts, Regulations, Directives, Policies etc.

Job Responsibility

To hold the Pharmacist Poison License Type A for the company to operate in Malaysia
To register Pharmaceuticals, Vaccines, Biologics, Biotechnology products and Medical Devices in Malaysia & Brunei
To renew and maintain Product Registration Licenses in Malaysia and Brunei
Perform Life-Cycle Management of all registered products in Malaysia & Brunei
To be the custodian for all matters pertaining to the registered products including archiving and retention of the product files
To create and approve artworks in Artwork Management System
To ensure the created and approved Artworks are in compliance with relevant national, regional and global labelling requirements
To ensure compliance to QMS processes and Artwork Management SOP for Pharma and Vaccines
To ensure timely revision of SOPs for compliance to the current regulatory requirements.

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

Regulatory Affairs Manager

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...

Location

Vietnam , Remote

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field
Minimum of 5 years’ experience working in regulatory affairs within the pharmaceutical or healthcare industry or in a consulting setting
Excellent project management and stakeholder engagement skills
Ability to work independently and in a fast-paced consulting environment
Ability to effectively project manage and deliver several projects at once

Job Responsibility

Regulatory Affairs activities for lifecycle management of pharmaceutical products
Support change applications (Administrative, Labelling, Chemistry Manufacturing & Controls, Safety) including submission strategy
Dossier compilation including preparation of documents (e.g. local forms, Cover Letters) and Table of Contents
Content review of Chemistry, Manufacturing & Controls/Labelling documentation/Justification documents
Alignment with functions on variation procedures, deficiency letter, e.g, Chemistry Manufacturing Controls, Medical Science, publishing team
Update/local Product Information (Labelling translation)
Check regulatory compliance of product information/artworks
Marketing Authorization withdrawal
Marketing Authorization Holder transfer
Licence renewal

Fulltime

Select Country

Regulatory Affairs Labelling Manager

Job Description

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Requirements

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