Regulatory Affairs Manager Job at Amgen (Beijing)

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

Regulatory Affairs Manager

Time for change – time for a new job! You are a regulatory affairs specialist an...

Location

Germany , Ludwigshafen am Rhein

Salary:

45000.00 - 60000.00 EUR / Year

Randstad

Expiration Date

June 30, 2026

Requirements

Bachelor's degree in life science, clinical research studies or engineering, ideally with previous regulatory experience
Several years of experience in a regulated business environment (e.g. legal office, regulated industry)
Experience working with Microsoft Office suite, most notably with Excel, Word, Outlook, Teams, and Microsoft SharePoint tools
Working knowledge of database management
Knowledge on current policies and practices issued by local German federal agencies
Awareness on regulatory policies/procedures to learn and better understand how the landscape of regulations develops
Good proficiency in the English language
Strong negotiation and communication skills as well as ability to organize data and identify issues or gaps in documentation

Fulltime

Regulatory Affairs Manager

The Regulatory Affairs Manager at Amgen ensures the company’s compliance with al...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate Degree
Master's Degree and 3 years of Regulatory CMC or related technical experience
Bachelor's Degree and 5 years of Regulatory CMC or related technical experience
Associates degree and 10 years of Regulatory CMC or related technical experience

Job Responsibility

Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments
Support development of global dossiers for CMC content of new marking applications (MAA), new clinical trials (CTA), variations and amendments to existing MAA/ CTAs
Development of post-approval submissions including maintenance of applications
Support Change Management activities
Respond to regulatory agency questions
Liaise with the Global RA CMC product lead, ROOTS representatives, and other functions in development, operations, and commercial to ensure alignment of global regulatory strategies and timing, execution
Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current
Participate as an active member of cross-functional teams

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

Fulltime

Regulatory Affairs Manager

If you feel like you're part of something bigger, it's because you are. At Amgen...

Location

Egypt , Cairo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

A bachelor's degree in Pharmacy or any relevant field
Minimum of 6 years of regulatory experience in the pharmaceutical industry or with Health Authorities
Excellent current regulatory knowledge understanding of US FDA and EMEA regulatory guidelines
Advanced ability to interpret scientific data and to construct persuasive regulatory documents
Good communication skills, ability to work effectively in a matrix setup
Strong knowledge of regulatory life cycle maintenance
Having People Management experience is critical
An analytical approach balanced with a keen eye for detail demonstrated in all document control and administration undertaken
Strong communication and leadership skills with the ability to select, motivate, train, and develop staff to achieve company goals

Job Responsibility

High-quality and timely Regulatory Affairs input to planned filings and approvals of new marketing authorizations (MA) and line-extensions
Maintain established products according to global and local regulatory plans
Update and maintain regulatory databases
Handle Health Authorities requests
Build and keep a highly professional relationship with the Medicines Agency
Support and interact with global regulatory affairs, QA, Market Access, Marketing (projects and product teams) and Sales to best support local and global strategy
Monitor future trends in regulatory affairs which are likely to affect AMGEN interest
Perform or facilitate audits to ensure compliance

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

Fulltime

Regulatory Affairs Manager

At Vodafone, we’re not just shaping the future of connectivity for our customers...

Location

United Kingdom , London

Salary:

Not provided

Vodafone

Expiration Date

Until further notice

Requirements

Strong analytical capability: Demonstrated ability to develop clear, practical, and business relevant regulatory advice in complex and sometimes ambiguous legal, regulatory, and political environments
Regulatory experience: Minimum 5+ years’ experience working with communications and digital markets regulation at EU and/or national level
Industry and technical understanding: Solid understanding of network and cloud technologies, as well as the commercial and operating models of the telecommunications and digital services industry
Communication skills: Strong written and verbal communication skills, with the ability to explain complex regulatory issues clearly to diverse stakeholders
Organisational effectiveness: Proven ability to work effectively in a complex, matrixed, and evolving organisational environment
Degree in Law, Economics, or a comparable technical or social sciences discipline

Job Responsibility

Ensure regulatory compliance capability: Enable Vodafone business functions to understand, implement, and effectively manage their regulatory compliance obligations
Subject-matter leadership: Serve as a lead expert e.g. on IoT, networks or other topics
Drive modern ways of working: Champion and endorse new ways of working, including the digitisation of regulatory processes and the responsible use of internal and external AI tools within the regulatory function
Regulatory authority engagement: Lead and manage communications with national and EU regulatory authorities, in close coordination with the Compliance and Governance function
Cross functional alignment: Ensure strong alignment and effective interlocking with local market regulatory teams and relevant Group functions to deliver consistent regulatory outcomes

What we offer

Yearly bonus: 10%
Annual leave: 28 days + bank holidays + the opportunity to buy/sell/carry over 5 days/year
Charity days: 5 days/year
Maternity leave: 52 weeks: the first 13 weeks are fully paid, followed by 26 weeks of half pay
Private pension: You can contribute up to 5% of your basic pay with 2:1 matching from Vodafone up to 10%
Access to: private medical, private dental, free health assessments, share save scheme
Additional discounts: Vodafone retail, gym, cinema, cycle to work, season ticket loan

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

Regulatory Affairs Manager

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

Location

Indonesia

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 Production Information (Labelling translation)
Check regulatory compliance of product information/artworks
Marketing Authorization withdrawal
Marketing Authorization Holder transfer
Licence renewal

Fulltime

Regulatory Affairs Manager

This role is in support of Almus & Alvita, a Cencora business offering a trusted...

Location

United Kingdom , Woking

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Degree in life science of science
Experience working within European Regulatory Affairs team, supporting pharmaceutical products and or medical devices or cosmetics
Competent in managing European Procedures (MRP/DCP’s)
Good communicator, both orally and in written form
Good interpersonal skills. Proven ability to operate within a multifunctional team
Analytical, diligent and accurate
Excellent organisational skills and ability to prioritise
Can do attitude, with strong accountability and ownership
Comfortable with a fast pace and switching between competing priorities
Fluent English

Job Responsibility

Responsible for managing the regulatory tasks in launching multiple NPD (New product Development) projects as part of a multifunctional team, in accordance with the budget and 5 year plans
Support the European Brand Manager and Central Sourcing Team in assessing potential new Alvita products, the launch in new territories, the evaluation of claims and product attributes of products offered by alternative suppliers
Review and approve Product Specifications and Artwork Management Sheets (AMS), supporting the launch of new Alvita products and update of existing products. Work collaboratively with other colleagues responsible for originating artwork and provide final approval of artwork for allocated projects
Assess the regulatory requirements for products ensuring the product and its labelling are legally compliant
Responsible for becoming the subject matter expert on medical devices within the business and ensuring plans are in place to maintain compliance with the requirements of Medical Devices Regulation (EU) 2017/745 and the in Vitro Diagnostic Medical Device Regulation (EU) 2017/746, in the context of our obligations as an own brand
Ensure that Regulatory Intelligence data is maintained and updated according to the relevant processes. Demonstrate an innovative approach to obtaining market intelligence from suppliers and/or other sources, which can support the brand and local commercial teams in identifying new product opportunities and developing long-term NPD plans
Support the business on regulatory impacting changes, to ensure the necessary steps are taken to mitigate risk to the business
Manage the preparation and submission of the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) Marketing Authorisation Applications (MAAs), involving more than one market
Co-ordinate the management of variations with suppliers and local regulatory teams for European Procedures involving more than one market, ensuring all MAs and products in market meet necessary legal compliance
Manage the preparation and maintenance of Regulatory Compliance Files with the local affiliates and suppliers for European Procedures involving more than one market

Fulltime

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