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Search Results for Regulatory Affairs Executive

Job Title.	Location	Salary	Actions
Principal Scientist Global Regulatory Affairs CMC Principal Scientist- Global Regulatory Affairs-CMC Our client, a global pharma company, are currently recruting for a Principal Scientist- Global Regulatory Affairs-CMC for their Cork based manufacturing site. This is a permanent role withhybrid working. As Principal Scientist- Global Regulatory Affairs-CMC you will provide strategic, tactical and operational direction to expedite the CMC development of the organisations portfolio and technical agenda by supporting global clinical trial, market registration submissions, and post-approval submissions. Resp... Location: Cork, Principal Scientist Global Regulatory Affairs CMC	Cork	Not Disclosed
Senior Regulatory Affairs Specialist Job title: Senior Regulatory Affairs Specialist Location: Parkmore, Galway. 1 day a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Reporting to the Se... Location: Athlone, Clare, Connaught, Galway, Galway City, Senior Regulatory Affairs Specialist	EU	Not Disclosed
Senior Regulatory Affairs Specialist Job title: Senior Regulatory Affairs Specialist Location: Parkmore, Galway. 1 day a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Reporting to the Se... Location: Athlone, Clare, Connaught, Galway, Galway City, Senior Regulatory Affairs Specialist	EU	Not Disclosed
Senior Regulatory Affairs Specialist Job title: Senior Regulatory Affairs Specialist Location: Parkmore, Galway. 1 day a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Reporting to the Se... Location: Athlone, Clare, Connaught, Galway, Galway City, Senior Regulatory Affairs Specialist	EU	Not Disclosed
Senior Regulatory Affairs Specialist Job title: Senior Regulatory Affairs Specialist Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Reporting to the Senior Reg... Location: Athlone, Clare, Connaught, Galway, Galway City, Senior Regulatory Affairs Specialist	EU	Not Disclosed
Principal Scientist Global Regulatory Affairs CMC Principal Scientist- Global Regulatory Affairs-CMC Our client, a global pharma company, are currently developing a state-of-the-art biotech manufacturing facility based in Limerick (hybrid working) and are currently recruiting for a Principal Scientist- Global Regulatory Affairs-CMC to join their team on a permanent basis. As Principal Scientist- Global Regulatory Affairs-CMC you will provide strategic, tactical and operational direction to expedite the CMC development of the organisations portfolio and technical agenda by supporting global clinical trial, market registration... Location: Limerick, Principal Scientist Global Regulatory Affairs CMC	Limerick	Not Disclosed
CMC Regulatory Principal Scientist CMC Regulatory Principal Scientist Our client, a global pharma company, are currently recruiting for a CMC Regulatory Principal Scientist to join their team on a permanent basis. This is an excellent opportunity to join a global team very strong of regulatory experts. This role offers hybrid working. As CMC Regulatory Principal Scientist, you will lead various aspects of the global marketing authorization submission management processes, help manage submission content for Drug Substance and Drug Product, provide guidance on structure and content placement within CTD registration... Location: Cork, CMC Regulatory Principal Scientist	Cork	Not Disclosed
CMC Regulatory Senior Scientist CMC Regulatory Senior Scientist Our client, a global pharma company, are currently recruiting for a CMC Regulatory Senior Scientist to join their team on a permanent basis. This is an excellent opportunity to join a global team very strong of regulatory experts. This role offers hybrid working. As CMC Regulatory Senior Scientist, you will lead various aspects of the global marketing authorization submission management processes, help manage submission content for Drug Substance and Drug Product, provide guidance on structure and content placement within CTD registration submissi... Location: Cork, CMC Regulatory Senior Scientist	Cork	Not Disclosed
Senior Regulatory Affairs Specialist Job title: Senior Regulatory Affairs Specialist – Post market Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Rep... Location: Athlone, Clare, Connaught, Galway, Galway City, Senior Regulatory Affairs Specialist	EU	Not Disclosed
Senior Reg Affairs Specialist - Post Market Job title: Senior Regulatory Affairs Specialist – Post market Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Overview: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Reporting to t... Location: Galway, Galway City, Senior Reg Affairs Specialist - Post Market	Galway	Not Disclosed
Senior Regulatory Affairs Specialist Job title: Senior Regulatory Affairs Specialist – Premarket Location: Parkmore, Galway. 1-2 days a week on site Benefits: Top salary, Bonus, pension, healthcare, hybrid working Company: My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. This role is best suited to an individual who is self-motivated, accountable and seeking infinite learning and growth opportunities. Role: As a Senior Regulatory Affairs Specialist you will will pl... Location: Clare, Connaught, Galway, Galway City, Limerick, Senior Regulatory Affairs Specialist	EU	Not Disclosed

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Regulatory Affairs Executive Career Profile

Regulatory Affairs Executive

The role concerns the filing and regulatory maintenance of Biopharmaceutical drug products. Depending on the company and the market authorisations for various drugs, Reg Affairs professionals will be required to deal with the IMB (Irish Medicines Board), MHRA (Medicines and Healthcare products regulatory Authority - UK) and FDA (Food & Drug Administration - US)

Responsibilities

Life cycle management and Maintenance of regulatory filings including annual reports and supplements to US FDA.
Preparation of registration submissions, in CTD (Clinical Trial Dossier) format, for biopharmaceutical products for approval by the US FDA, European Regulatory Authorities and worldwide, as required.
Monitoring the progress of registration submissions, responding to queries and ensuring that registration approvals are granted without undue delays.
Regulatory Compliance, for change control activities monitoring the impact of changes in regulatory submissions.
Monitoring adverse events for submissions, preparation and review and generation of supporting documents for potential field alerts and recalls.
Maintenance of approvals, including the preparation of annual reports for US products.
Assess and review documentation to ensure compliance with product licences.
Undertake general regulatory activities that interface with other departments such as Manufacturing, Product Development, Quality Control and Quality Assurance.
Actively participate in project teams, as required.

Qualifications / Experience

Minimum of 3 years regulatory experience in the pharmaceutical industry.
Knowledge of the current regulatory requirements, particularly US and EU.
Experience in writing and submitting regulatory documentation.

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