CrawlJobs Logo
Amgen Logo Amgen · IT - Administration

Eu Regulatory Affairs Senior Manager - General Medicine

United Kingdom; Portugal, Cambridge Employment contract · Job Posted May 05, 2026
Apply Position
Job Link Share

Job Description

In this vital role you will work to ensure that Amgen acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products. Representing the region, you will be responsible for advising the GRT on regional considerations in developing strategy, and ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.

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
  • Implement product related regulatory strategies, Regulatory Affairs processes and activity planning
  • Lead development of regional regulatory documents and meetings in accordance with GRT strategy
  • Provide regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plan)
  • Participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
  • Consistent with GRT strategy, advise on regulatory implications and requirements related to global clinical development plans and objectives
  • Lead Health Authority and Agency Interactions and document and communicate outcomes appropriately

Requirements

  • Degree educated in a scientific discipline
  • Extensive experience in regional regulatory environment
  • Proven track record of developing and executing regional regulatory strategy
  • In-depth understanding of the drug life cycle and development process from a regulatory perspective
  • In-depth understanding of the registration procedures in region for MA, post approval changes, extensions and renewals
  • Ability to lead teams and work collaboratively in a dynamic environment
  • Proactive approach to problem solving
  • Ability to understand and communicate scientific/clinical information
  • Ability to anticipate regulatory agency expectations
  • Strong awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development

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
  • flexibility to work from home
Amgen - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Eu Regulatory Affairs Senior Manager - General Medicine

8 matching positions

Senior Regulatory- Labelling

Join Our Team as a Regulatory Affairs Labelling Expert! Are you ready to make a ...
Location
Location
Salary
Salary:
Not provided
cencora.com Logo
Cencora
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Language Proficiency: Fluent business English (or native English), with additional EU language skills as a plus
  • Educational Background: A degree in pharmacy, medicine, life sciences, or a bachelor’s degree in science
  • Regulatory Affairs Expertise: Proven experience in regulatory affairs with a strong track record in labelling activities for innovator drugs on a global level
  • Lifecycle Management: Experience in handling marketing authorizations and their lifecycle management
  • Regulatory Knowledge: Sound understanding of pharmaceutical and regulatory requirements in the EU and ideally in one ICH region
  • Technical Skills: Affinity for databases, labelling software tools, and project management software, with the ability to monitor and adhere to timelines
  • Personal Attributes: Team player with excellent communication skills, conscientious, accurate, and responsible
  • Software Proficiency: Confident in using MS Excel, MS Word, databases, and document management systems
Job Responsibility
Job Responsibility
  • Participation in the preparation and revision and compilation of the informative texts for healthcare professionals and patients (SmPC, PIL, Labelling) in EU and also for non-EU markets, preferably including development of target product/labelling profiles
  • Manages creation and maintenance of CCDS/CCSI/RSI, as applicable, in direct collaboration with relevant departments/expert functions responsible for CCDS section content (e.g. from medical, safety department)
  • Ensures communication to internal / external stakeholders regarding new and updated CCDSs and Product Information
  • Escalates deviation and compliance issues to the labelling governance bodies (e.g. Safety monitoring committee, Global labelling boards) as necessary
  • Experience in labelling documentation and informative texts for innovator drugs on a global (headquarter) level
  • Planning and expediting the approval projects using the internally available or client-based software tools including databases and document management systems
  • Providing regulatory expertise to regulatory programs and projects as well as to clients
  • General guidance (consultancy) of Cencora staff and customers regarding Regulatory Submissions & Labelling activities including also updates on new trends and/or changes in legislation
  • Creation, revision, editing and maintenance of regulatory documentation
  • Professional interaction with clients and Health Authorities
  • Fulltime
Read More
Arrow Right
New

Dc Operations Manager

The Distribution Center (DC) Operations Manager is responsible for driving opera...
Location
Location
Canada , Cambridge
Salary
Salary:
100000.00 - 120000.00 USD / Year
uapinc.com Logo
Uap Inc.
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum of 10 years of experience managing Distribution Center operations
  • Proven track record of managing gross profit performance, with a strong understanding of financial statements and budgeting for large-scale operations
  • Experience in the automotive aftermarket industry is considered an asset
  • Strong computer skills, including proficiency in MS Office and Warehouse Management Systems (WMS)
Job Responsibility
Job Responsibility
  • Lead Distribution Center operations to achieve financial, operational, and customer service goals
  • Implement and monitor strategies, policies, and process improvements to enhance efficiency and performance
  • Train, coach, and support Warehouse Managers and the Distribution Center Management team
  • Partner with the General Manager to set priorities, develop action plans, and support business cases for investments
  • Oversee labor relations, including collective agreements and committee participation
  • Manage carrier relationships and returns processes
  • Participate as a member of the regional management committee
What we offer
What we offer
  • comprehensive benefits program
  • access to corporate discounts
  • ongoing training and development opportunities
  • Fulltime
Read More
Arrow Right
New

Senior Data Engineer

Roku is changing how the world watches TV. Roku is the #1 TV streaming platform ...
Location
Location
India , Bengaluru
Salary
Salary:
Not provided
roku.com Logo
Roku
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Extensive SQL Skills
  • Proficiency in at least one scripting language, Python is required
  • Experience in big data technologies like HDFS, YARN, Map-Reduce, Hive, Kafka, Spark, Airflow, Presto, etc.
  • Proficiency in data modeling, including designing, implementing, and optimizing conceptual, logical, and physical data models to support scalable and efficient data architectures
  • Experience with AWS, GCP, Looker is a plus
  • Collaborate with cross-functional teams such as developers, analysts, and operations to execute deliverables
  • 8+ years professional experience as a data Engineer
  • BS in Computer Science
  • MS in Computer Science preferred
  • AI Literacy / AI growth mindset
Job Responsibility
Job Responsibility
  • Build highly scalable, available, fault-tolerant distributed data processing systems (batch and streaming systems) processing over 10s of terabytes of data ingested every day and petabyte-sized data warehouse
  • Build quality data solutions and refine existing diverse datasets to simplified data models encouraging self-service
  • Build data pipelines that optimise on data quality and are resilient to poor quality data sources
  • Own the data mapping, business logic, transformations and data quality
  • Low level systems debugging, performance measurement & optimization on large production clusters
  • Participate in architecture discussions, influence product roadmap, and take ownership and responsibility over new projects
  • Maintain and support existing platforms and evolve to newer technology stacks and architectures
What we offer
What we offer
  • Global access to mental health and financial wellness support and resources
  • Healthcare (medical, dental, and vision)
  • Life, accident, disability, commuter, and retirement options (401(k)/pension)
  • Time off in accordance with local leave policies
  • Fulltime
Read More
Arrow Right
New

Driver (Temporary)

Location
Location
Canada , Edmonton
Salary
Salary:
Not provided
uapinc.com Logo
Uap Inc.
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Valid driver's license
  • Ability to lift up to 50 lbs
  • Excellent customer service and communication skills.
Job Responsibility
Job Responsibility
  • Responsible for the delivery of parts and accessories
  • Verifying orders before and during delivery
  • Loading and unloading parts as required
  • Communicate effectively with customers and colleagues
  • Provide excellent customer service in a professional and friendly manner.
  • Fulltime
Read More
Arrow Right
New

IKEA Food Assistant - SFM & Bistro

About the job Attracting visitors to the stores, encouraging IKEA store visitor...
Location
Location
Thailand , Samutprakarn
Salary
Salary:
Not provided
https://www.ikea.com Logo
IKEA
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Previous service environment experience, ideally sales or hospitality
  • Experience of working in a fast-paced environment
  • Computer literate, specifically MS Office
  • Curious and eager to learn more in order to grow both the business and as a person
  • Interested in people's everyday life at home and in-home furnishings
  • Confident in approaching and talking to people in a friendly manner
  • Good attention to detail and the ability to prioritise and organise individual work duties in order to make the most efficient use of time available
Job Responsibility
Job Responsibility
  • Assists the manager and support the team by actively contribute to the development and implementation of a clear IKEA Food action plan for the store
  • Work to ensure that the area of responsibility is clean, tidy, organised, priced, attractive and inviting at all times
  • Contribute to an easy buying process that will make it easy and convenient for our customers to shop in the store at all times throughout the day
  • Comply with and follow internal rules, policies and daily operational routines regarding issues like quality, food safety and stock figures as set by my manager
  • Works proactively to avoid bottlenecks and consistently improve customer satisfaction
  • Assists the manager in good sales forecast, thus enabling proper supply planning, ordering, efficient goods handling and stock control
  • Contribute and support relevant marketing and instore activities
  • Fulltime
Read More
Arrow Right
New

Fiber Installation Technician

National OnDemand, Inc. is a communications and utilities infrastructure provide...
Location
Location
United States , Dallas
Salary
Salary:
Not provided
nationalondemand.com Logo
NATIONAL OnDemand, Inc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Lift and carry up to 80lbs
  • Climb ladders up to 14′ with total load capacity of 300 pounds
  • Work in attics and other limited-space areas
  • Bend, kneel, crouch, and stand for long periods
  • Safety culture is strong at National OnDemand, and our team members attend weekly safety meetings
  • Experience with Fiber Optics installs preferred
  • Exceptional customer service skills
  • Field experience is helpful and ability to use basic installation and hand tools
  • Someone who is self-motivated
  • Willingness to work in all types of weather conditions
Job Responsibility
Job Responsibility
  • Earn a competitive hourly wage and enjoy an unlimited production bonus plan
  • Become an expert on broadband cable installation by participating in our onsite training program
  • Provide exemplary customer service
  • Install, service, and troubleshoot cutting-edge technology in customer homes
  • Control your own income by the amount of jobs completed
What we offer
What we offer
  • paid time off (PTO)
  • medical
  • dental
  • vision
  • short- and long-term disability
  • life insurance
  • Employee Assistance Program (EAP)
  • 401(k)
  • Fulltime
Read More
Arrow Right
New

Installation Manager

National OnDemand, Inc. is a communications and utilities infrastructure provide...
Location
Location
United States , Columbus
Salary
Salary:
Not provided
nationalondemand.com Logo
NATIONAL OnDemand, Inc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High School Diploma or equivalent required
  • 3-5 years of leadership experience
  • Possession of valid state issued driver’s license required
  • Must be able to pass a background check and drug screen
  • Must have a minimum of three years of experience in a related discipline
  • Proven leadership and teamwork skills fostering an inclusive, supportive environment by motivating and developing staff at all levels
  • Critical thinking and analytical skills, including the capacity to identify, assess and prioritize competing interests and needs
  • Proven ability to adjust quickly to shifting priorities, multiple demands, ambiguity, and rapid change
  • Ability to coordinate and integrate work across multiple disciplines, complete scheduling, and resource planning activities to drive efficient work processes, identify and manage all operational risks, and enhance customer communication and satisfaction
  • Experience managing multiple locations and leading cross-functional teams
Job Responsibility
Job Responsibility
  • Represent the company and attend client’s meetings with Regional Manager and maintain a great relationship with clients
  • Drive profitability by optimizing profits and controlling expenses
  • Provides technical support, expertise, leadership, and accountability for field team
  • Responsible for recruiting, hiring, retention and training needs for field staff
  • Builds and maintains an effective field operations organization committed to customer and employee satisfaction
  • Supervise performance of field staff and responds to escalated issues in field
  • Communicate senior management directives to field staff and ensure compliance (Safety, etc.)
  • Develops manpower schedules and loading to ensure workload coverage
  • Site Visits to ensure QC of various projects ensure conformance to client specifications and company requirements
  • Follows up on customer satisfaction issues and drives resolution
What we offer
What we offer
  • paid time off (PTO)
  • medical
  • dental
  • vision
  • short- and long-term disability
  • life insurance
  • Employee Assistance Program (EAP)
  • 401(k)
  • Fulltime
Read More
Arrow Right
New

Senior Direct Procurement Manager

Roku is changing how the world watches TV. The Direct Procurement team is respon...
Location
Location
United States , San Jose
Salary
Salary:
185000.00 - 230000.00 USD / Year
roku.com Logo
Roku
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Supply Chain Management, Engineering, Business, or a related field (Master's or MBA preferred)
  • 8+ years of experience in hardware procurement, sourcing, or supply chain within the consumer electronics or high-tech industry
  • Strong understanding of components sourcing and semiconductor supply chain
  • Experience in a tech start-up or scaling a hardware company
  • Experience in executive reporting, including preparing and presenting supplier strategy, risk, and cost updates to senior leadership
  • A proven track record supporting Product Development Process (PDP) and managing procurement during New Product Introduction (NPI) phases
  • Experience working with CMs/ODMs and international suppliers
  • Strong negotiation, contract management, and analytical skills
  • Ability to thrive in a fast-paced, dynamic environment with multiple priorities
  • Strong written and verbal communication skills
Job Responsibility
Job Responsibility
  • Develop, implement, and manage global sourcing strategies for hardware components, including System-on-Chip (SOC), memory, and other semiconductors, as well as manufacturing services, including CM, ODM, and JDM partnerships
  • Identify and qualify new suppliers
  • manage supplier relationships to ensure performance on cost, quality, lead time, and capacity
  • Lead RFI/RFQ/RFP processes and cost negotiations
  • Lead contract negotiations, including NDAs, MDSA, SOWs, and other supply agreements
  • Partner with Product and Engineering throughout the Product Development Process (PDP, ensuring sourcing is aligned with technical and timeline requirements
  • Support design-to-cost decisions during development and cost initiatives for sustaining programs
  • Analyze cost drivers and market trends to improve pricing and reduce the total cost of ownership (TCO)
  • Identify supply chain risks and implement mitigation strategies like alternative second sourcing, buffer stocks, or redesigns
  • Ensure accurate BOM cost roll-ups and reporting of pricing data
What we offer
What we offer
  • Health insurance
  • equity awards
  • life insurance
  • disability benefits
  • parental leave
  • wellness benefits
  • paid time off
  • global access to mental health and financial wellness support and resources
  • healthcare (medical, dental, and vision)
  • life, accident, disability, commuter, and retirement options (401(k)/pension)
  • Fulltime
Read More
Arrow Right