Senior Regulatory Affairs Manager

Collins McNicholas Recruitment; Leinster; Hybrid; EUR 75,000 - 95,000; Full time

Job summary

A leading company in healthcare innovation is seeking a Senior Regulatory Affairs Manager based in Athlone, Co. Westmeath. This permanent role involves managing regulatory activities, developing strategies for new products, and preparing submissions to regulatory authorities, offering an attractive benefits package and hybrid work arrangements.

Qualifications

• 5 years of Regulatory/CMC authoring experience in a pharmaceutical company.
• Experience in new market access filing and post-approvals.
• Ability to collaborate with stakeholders and manage multiple projects.

Responsibilities

• Prepare and deliver high-quality CMC regulatory submissions for global agencies.
• Contribute to regulatory strategies and manage submission information.
• Lead regulatory affairs-related projects.

Skills

Project Management

Communication

Interpersonal Skills

Leadership

Detail-oriented

Education

Bachelor's/Graduate degree in relevant science discipline

Job description

Our client, a globally recognised leader inhealthcare innovation, based inAthlone, Co. Westmeathis seeking aSenior Regulatory Affairs Manager to join their team. The successful person will take charge of managing regulatory activities and projects, developing regulatory strategies for new products, and handling submissions to regulatory authorities while supporting the company's growing regulatory needs. This is a permanent position offering an attractive benefits package and hybrid arrangements.

Key Responsibilities:

• Prepare and deliver high-quality CMC regulatory submissions for global agencies

• Contribute to regulatory strategies and manage submission information, tracking commitments and timelines

• Collaborate with stakeholders, provide consultation, and resolve regulatory issues

• Manage submissions for new registrations, post-approval changes, renewals, and line extensions

• Maintain global regulatory approvals and ensure timely responses to agency queries

• Lead regulatory affairs-related projects

Essential Criteria:

• Bachelor's/Graduate degree in a relevant science discipline (Biology, Chemistry, Pharmacy)

• Minimum 5 years of Regulatory/CMC authoring experience in a Pharmaceutical company is essential

• New market access filing and post-approvals experience

• Experience liaising with CMOs

• Excellent written, oral communication, and project management skills

Core Competencies:

• Action-oriented, detail-focused, and results-driven

• Strong leadership, interpersonal, and presentation skills

• Ability to manage multiple projects and respond effectively to change

For a confidential discussion about the role of Senior Regulatory Affairs Manager in Athlone, please contact Ranait Coughlan.

[e-mail]

[phone](01) 66 200 88