Regulatory Affairs Manager

5 days ago


Dublin, Ireland Parexel Full time

When our values align, there's no limit to what we can achieve.
 

Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team This is a client dedicated project, and the role can be office or home based in various European locations.

As the CMC Regulatory Manager, you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological products.

Primary Tasks & Responsibilities:

Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.

Assess change controls and provide regulatory assessments of quality changes in production and quality control.

Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.

Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.

Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.

Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.

Identify, escalate, and mitigate risks associated with regulatory procedures and activities.

Experience and Knowledge Requirements:

University-level education, preferably in Life Sciences, or equivalent by experience.

Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.

Strong understanding of CMC and post-approval regulatory requirements.

Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations.

Knowledge of biological processes.

Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of qualification/validation principles.

Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.

Team spirit, flexibility, accountability, and organizational skills.

Fluent in English (written and spoken). French, Italian and German would be a strong plus.



  • Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Regulatory Affairs ManagerMy client, a multinational medical device and health care company, is looking to recruit a Regulatory Affairs Manager. The Regulatory Affairs Manager will be in charge of managing teams within the Regulatory Affairs Sub-Function. The core focus of this position is on policy and strategy implementation and control rather than...


  • Dublin, Dublin City, Ireland Robert Walters Ireland Full time

    We are excited to be working with a global leading Investment firm in Dublin who are looking for a Regulatory Affairs Manager to join the business. This role offers a unique opportunity to shape the firm's regulatory policies and ensure compliance across multiple jurisdictions.As a Regulatory Affairs Manager, you will conduct horizon scanning for regulatory...


  • Dublin, Dublin City, Ireland Robert Walters Ireland Full time

    Regulatory Affairs ManagerRobert Walters Ireland is seeking an experienced Regulatory Affairs Manager to join their Risk and Compliance team. This key role will be responsible for ensuring our client's adherence to data protection laws and regulations, handling complaints efficiently, and maintaining ISO certification standards.The ideal candidate will have...


  • Dublin, Dublin City, Ireland Robert Walters Full time

    We are seeking a highly skilled Regulatory Affairs Manager to join our Risk and Compliance team at Robert Walters. In this role, you will play a crucial part in ensuring that our business operates within the boundaries of data protection laws and regulations.As a Regulatory Affairs Manager, your responsibilities will include conducting regular data...


  • Dublin, Dublin City, Ireland Blackhawk Network (GVS) Full time

    **Head of Regulatory Affairs:We are seeking a highly experienced professional to join our team as a Head of Regulatory Affairs. In this role, you will be responsible for leading our regulatory affairs function and ensuring that our business operations are in compliance with all relevant regulations and laws.The ideal candidate will have extensive knowledge...


  • Dublin, Dublin City, Ireland Flexjet Europe Full time

    We are seeking an experienced Regulatory Affairs Manager to join our team at Flexjet Europe. In this role, you will be responsible for ensuring that the organization remains compliant with aviation regulations and standards.This will involve performing internal audits, analyzing compliance data, and creating reports to support timely and effective closure of...


  • Dublin, Dublin City, Ireland Cpl Healthcare Full time

    JOB DESCRIPTION FORM Thornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin. Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.The role & Responsibilities: Take lead role and responsibility for the...


  • Dublin, Dublin City, Ireland GxP Recruitment Full time

    In this role you will be in charge of managing teams within the Regulatory Affairs Sub-Function.Focus is on policy and strategy implementation and control rather than development and you will typically handle short-term operational/tactical responsibilities.As the Manager of the Regulatory Affairs Sub-Function, you will be responsible to:Oversee the strategy...


  • Dublin, Ireland Cpl Full time

    Regulatory Affairs Officer & Senior Regulatory Affairs OfficerThornshaw Scientific, in collaboration with my client, a global pharmaceutical company, now have a new opportunity for a Regulatory Affairs Officer to join the Dublin team. The same company also have Senior Regulatory Affairs Officer opportunities.Key Responsibilities:Manage EU marketing...


  • Dublin, Dublin City, Ireland Cpl Healthcare Full time

    **Job Overview**Cpl Healthcare is seeking an experienced Regulatory Affairs Manager to join our team. As a key member of the organization, you will be responsible for managing teams within the Regulatory Affairs Sub-Function.


  • Dublin, Dublin City, Ireland Thornshaw Recruitment Full time

    Thornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin.Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.The role & Responsibilities:To take lead role and responsibility for the effective planning,...


  • Dublin, Dublin City, Ireland RedChair Recruitment Full time

    What we are looking for: You will ensure that the requirements of the industry and regulatory bodies are fulfilled. You will be Responsible for the communications and interactions with the Competent Authorities in relation to the Authorized Representative duties. You will contribute to Regulatory Affairs activities across the company, ensuring...


  • Dublin, Dublin City, Ireland Cpl Full time

    Regulatory Affairs Officer & Senior Regulatory Affairs OfficerThornshaw Scientific, in collaboration with my client, a global pharmaceutical company, now have a new opportunity for a Regulatory Affairs Officer to join the Dublin team. The same company also have Senior Regulatory Affairs Officer opportunities.Key Responsibilities:Manage EU marketing...


  • Dublin, Dublin City, Ireland Cpl Full time

    Job Title: Regulatory Affairs SpecialistAbout the Role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Dublin. As a Regulatory Affairs Specialist, you will be responsible for managing EU marketing authorisation dossiers and submissions, preparing and filing EU submissions, and writing local modules and administrative...


  • Dublin, Dublin City, Ireland Thornshaw Recruitment Full time

    Thornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin.Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.The role & Responsibilities:To take lead role and responsibility for the effective planning,...


  • Dublin, Dublin City, Ireland Parexel Full time

    When our values align, there's no limit to what we can achieve.   Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team This is a client dedicated project, and the role can be office or home based in various...

  • Regulatory Affairs

    2 weeks ago


    Dublin, Dublin City, Ireland Thornshaw Recruitment Full time

    Thornshaw Scientific, in collaboration with my client, a global pharmaceutical company, now have a new opportunity for a Regulatory Affairs Officer to join the Dublin team.Key Responsibilities:Manage EU marketing authorisation dossiers and submissions (MAAs, lifecycle activities, variations, transfer etc.) for our current portfolio of pharmaceutical...


  • Dublin, Dublin City, Ireland Robert Walters Ireland Full time

    A leading Fintech Company in Dublin is seeking an experienced Regulatory Affairs Specialist to join their team.This role involves ensuring the company's compliance with regulatory standards and managing relations with the Central Bank of Ireland (CBI).The successful candidate will be responsible for developing the compliance strategy, aligning it with...


  • Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Thornshaw Scientific, in collaboration with a global pharmaceutical company, is seeking an experienced Regulatory Affairs Specialist to join the Dublin team.The role presents an opportunity for individuals with a strong background in EU regulatory affairs to contribute to the development and maintenance of marketing authorisation dossiers and submissions.Key...


  • Dublin, Dublin City, Ireland CPL Full time

    At Thornshaw Scientific, our collaboration with a leading global pharmaceutical company has led to an exciting opportunity for a skilled Regulatory Affairs Officer to join our Dublin team.About the RoleThe successful candidate will be responsible for managing EU marketing authorisation dossiers and submissions, including lifecycle activities, variations,...