Regulatory Affairs Manager

3 weeks ago

Cashel, Ireland recruitireland - jobboard Full time

We are seeking an experienced Regulatory Affairs Manager to join a global pharmaceutical leader. This role offers the opportunity to lead regulatory activities, manage submissions, and develop global regulatory strategies.

What You'll Do
  • Lead regulatory strategy for key projects, ensuring compliance with global requirements.
  • Manage regulatory submissions, including new registrations, post-approval changes, renewals, and technical variations.
  • Track regulatory commitments, assess risks, and provide strategic input on development plans.
  • Act as a scientific and technical resource, mentoring colleagues and sharing expertise.
  • Prepare responses to regulatory authority queries, ensuring timely and high-quality submissions.
  • Stay updated on evolving regulations and assess their impact on existing and future products.
  • Collaborate with internal stakeholders across R&D, Manufacturing, and Regulatory Affairs.
  • Engage with regulatory authorities (HPRA and other EU bodies) to support marketing authorisation applications.
  • Review GMP documents such as change controls, deviations, and batch manufacturing records.
  • Represent the company at industry conferences and regulatory advisory committees.
What You Need

Experience: Minimum 5+ years in Regulatory Affairs within the pharmaceutical industry.

Knowledge: Strong understanding of EU and global regulatory frameworks, including HPRA submissions.

Skills: Excellent project management, communication, and stakeholder engagement.

Education: Degree in Life Sciences, Pharmacy, or a related discipline.

Advantageous: Experience in CMC, post-market surveillance, and regulatory strategy development.

Why Join Us?

Competitive salary + Annual Incentive Plan

Work with a global pharma leader in an impactful regulatory role.

Collaborative environment with strong career development opportunities.

Exposure to international markets and regulatory bodies.

If you're a regulatory expert looking to take the next step in your career, apply now

#J-18808-Ljbffr

  • GMP Regulatory Compliance Specialist

    4 days ago

    Cashel, Ireland Cpl Full time

    Cpl is hiring an experienced Quality Control professional to join our team as a QC Laboratory Supervisor.The successful candidate will have a proven track record of leading analytical activities in a GMP-regulated environment, with expertise in method validation, troubleshooting, and analytical method transfers. They will be responsible for overseeing all...

  • Laboratory Manager – Microbiology

    7 days ago

    Cashel, Ireland Cpl Full time

    Laboratory Manager – Microbiology | Pharma Client | CashelOur pharma client based in Cashel is looking for a Laboratory Manager – Microbiology to join their team. This is a leadership role in a growing organisation, responsible for developing microbiology testing processes, managing laboratory operations, and ensuring compliance with regulatory...

  • Laboratory Manager – Microbiology

    8 hours ago

    Cashel, Ireland Cpl Full time

    Laboratory Manager – Microbiology | Pharma Client | CashelOur pharma client based in Cashel is looking for a Laboratory Manager – Microbiology to join their team. This is a leadership role in a growing organisation, responsible for developing microbiology testing processes, managing laboratory operations, and ensuring compliance with regulatory...

  • Microbiology Laboratory Manager

    6 days ago

    Cashel, Ireland Cpl Resources - Limerick Full time

    Laboratory Manager – Microbiology | Pharma Client | CashelOur pharma client based in Cashel is looking for a Laboratory Manager – Microbiology to join their team. This is a leadership role in a growing organisation, responsible for developing microbiology testing processes, managing laboratory operations, and ensuring compliance with regulatory...

  • Pharma Lab Manager

    6 days ago

    Cashel, Ireland Cpl Resources - Limerick Full time

    Microbiology Laboratory Manager PositionWe are seeking an experienced Microbiology Laboratory Manager to join our team at Cpl Resources - Limerick. In this role, you will be responsible for developing and implementing microbiology testing processes, managing laboratory operations, and ensuring compliance with regulatory requirements.Key...

  • Lab Operations Manager in Microbiology

    6 days ago

    Cashel, Ireland Cpl Resources - Limerick Full time

    Microbiology Lab Operations ManagerCpl Resources - Limerick is seeking an experienced Microbiology Lab Operations Manager to join our team. In this role, you will be responsible for managing laboratory operations, including staff supervision, inventory management, and equipment maintenance.Key Responsibilities:Manage laboratory operations, including staff...

  • Analytical Operations Manager

    4 days ago

    Cashel, Ireland Cpl Full time

    We're seeking an experienced Quality Control professional to lead analytical activities in a fast-paced GMP-regulated biopharma environment.The ideal candidate will have a strong background in analytical techniques and leadership, with 5+ years of QC experience in a GMP-regulated laboratory (2+ years in a supervisory role). They will oversee all QC/ARD...

  • Document Controller

    7 days ago

    Cashel, Ireland Cpl Full time

    Document Controller – Pharmaceutical (GMP) – CashelOur pharma client based in Cashel is looking for a Document Controller to join their team. This role involves managing and controlling GMP documentation to support production, quality, and compliance activities.Key Responsibilities:Implement and manage an Electronic Document Management System...

  • Head of Microbiology Quality Assurance

    6 days ago

    Cashel, Ireland Cpl Resources - Limerick Full time

    Head of Microbiology Quality AssuranceWe are seeking an experienced Head of Microbiology Quality Assurance to join our team at Cpl Resources - Limerick. In this role, you will be responsible for ensuring compliance with regulatory requirements, including quality control and quality assurance procedures.Key Responsibilities:Ensure compliance with regulatory...

  • Senior Microbiologist Team Lead

    6 days ago

    Cashel, Ireland Cpl Resources - Limerick Full time

    Laboratory Manager – MicrobiologyCpl Resources - Limerick is seeking an experienced Laboratory Manager – Microbiology to lead our pharma client's microbiology team. This role involves developing and implementing microbiology testing processes, managing laboratory operations, and ensuring compliance with regulatory requirements.Key Responsibilities:Lead...

  • Quality Control Team Lead

    4 days ago

    Cashel, Ireland Cpl Full time

    Cpl is seeking a skilled Quality Control professional to join our team as a QC Supervisor.The successful candidate will have a proven track record of leading analytical activities in a GMP-regulated environment, with expertise in method validation, troubleshooting, and analytical method transfers. They will be responsible for overseeing all QC/ARD Laboratory...

  • Renewable Energy Specialist

    3 days ago

    Cashel, Ireland Stakelum Consultancy Full time

    At Stakelum Consultancy, we are seeking a highly skilled Renewable Energy Specialist to join our team. The successful candidate will play a key role in supporting our renewable energy clients.The ideal candidate will have a strong background in finance and accounting, with experience in conducting research and preparing reports. They will be responsible for...

  • Support Worker, St. Patricks Gardens

    1 week ago

    Cashel, Ireland TN Ireland Full time

    Client:Brothers of CharityLocation:Cashel, IrelandJob Category:OtherEU work permit required:YesJob Reference:51c8a02672d8Job Views:65Posted:22.01.2025Expiry Date:08.03.2025Job Description:BROTHERS OF CHARITY SERVICES IRELAND - SOUTH EAST REGIONSOUTH TIPPERARY SERVICESPermanent Full Time (78 hours per fortnight) Support Worker, St. Patrick's Gardens, Dun...

  • QC Laboratory Supervisor

    4 days ago

    Cashel, Ireland Cpl Full time

    We're looking for an experienced Quality Control professional to join our team as a QC Supervisor.The successful candidate will have a strong background in analytical techniques and leadership, with 5+ years of QC experience in a GMP-regulated laboratory (2+ years in a supervisory role). They will oversee all QC/ARD Laboratory activities, ensuring timely...

  • Sustainability and Finance Expert

    3 days ago

    Cashel, Ireland Stakelum Consultancy Full time

    We are seeking an experienced Sustainability and Finance Expert to join our team at Stakelum Consultancy. As a Sustainability and Finance Expert, you will play a key role in supporting our renewable energy clients and contributing to the development of our company's initiatives.The ideal candidate will have a strong background in finance and accounting, with...

  • Corporate Finance Professional

    3 days ago

    Cashel, Ireland Stakelum Consultancy Full time

    Stakelum Consultancy is looking for a talented Corporate Finance Professional to join our team. As a Corporate Finance Executive, you will play a key role in supporting our renewable energy clients and contributing to the development of our company's initiatives.The ideal candidate will have a strong background in finance and accounting, with experience in...

  • Financial Analyst

    3 days ago

    Cashel, Ireland Stakelum Consultancy Full time

    Are you an experienced Financial Analyst looking to make a career move into the renewable sector? Do you have a passion for sustainability and finance? We are seeking a Financial Analyst - Renewable Sector to join our team at Stakelum Consultancy.The ideal candidate will have a strong background in finance and accounting, with experience in conducting...

  • QC Supervisor

    3 weeks ago

    Cashel, Ireland Cpl Full time

    We're Hiring: QC Supervisor – CashelAre you an experienced Quality Control professional with a strong background in analytical techniques and leadership? We're looking for a QC Supervisor to lead analytical activities in a fast-paced GMP-regulated biopharma environment.What We're Looking For:BSc/MSc in Chemistry, Biochemistry, or a related field5+ years of...

  • QC Supervisor

    4 days ago

    Cashel, Ireland Cpl Full time

    We're Hiring: QC Supervisor – CashelAre you an experienced Quality Control professional with a strong background in analytical techniques and leadership? We're looking for a QC Supervisor to lead analytical activities in a fast-paced GMP-regulated biopharma environment.What We're Looking For:BSc/MSc in Chemistry, Biochemistry, or a related field5+ years of...

  • Corporate Finance Executive

    3 days ago

    Cashel, Ireland Stakelum Consultancy Full time

    Full Job DescriptionThe Corporate Finance Executive will play a role in supporting our team and renewable energy clients. They will be responsible for conducting research, preparing reports, assisting clients with their renewable projects, and contributing to the development of renewable-focused initiatives within Stakelum Consultancy.Key...