Senior Regulatory Affairs Specialist
About the job
Senior Regulatory Affairs Specialist
Our client is a global pharmaceutical leader seeking a Senior Regulatory Affairs Specialist to join their regional regulatory team. This role is a cornerstone of the organization's compliance strategy, serving as a primary link between product development and the market.
Reporting to the Regulatory Affairs Lead, you will manage the end-to-end lifecycle of medicinal drug products. Your success will be defined by your ability to secure marketing authorizations, navigate complex labelling requirements, and maintain seamless compliance across EU, UK, and international markets.
The Impact You'll Make
You will ensure that life-changing medicinal products reach patients and remain on the market legally and safely. You will sit at the intersection of Science, Quality, and Commercial, translating complex regulations into actionable submission strategies.
Key Responsibilities
- Submissions & Lifecycle Management: Lead the coordination and submission of high-quality dossiers (MAs, variations, renewals, and line extensions) using CP, DCP, NP, and UK IRP procedures.
- Labelling & Artwork Governance: Act as the regulatory lead for SmPC, PIL, and labelling texts. You will manage the entire labelling lifecycle, ensuring alignment with approved dossiers and health authority requirements.
- MAH Compliance: Support Marketing Authorisation Holder (MAH) obligations by overseeing change controls, safety-related updates, and post-marketing compliance activities.
- Cross-Functional Collaboration: Partner with Pharmacovigilance (PV), Quality, and Commercial teams to assess safety signals and ensure supply chain continuity.
- Vendor Oversight: Serve as the primary point of contact for external regulatory service providers and artwork vendors, ensuring high-quality, timely deliverables.
- Process Excellence: Contribute to the refinement of eCTD publishing standards and internal Regulatory Information Management (RIM) systems.
Requirements
- Full Irish Working rights, no sponsorship available.
- Expertise: Minimum 7+ years of experience in EU/UK pharmaceutical Regulatory Affairs.
- Education: A degree in Pharmacy, Life Sciences, Chemistry, or a related pharmaceutical discipline.
- Technical Proficiency: Hands-on experience with EU regulatory procedures (CP, DCP, NP) and a strong grasp of eCTD standards.
- Labelling Mastery: Demonstrated experience managing labelling and artwork workflows within a regulatory framework.
- Niche Knowledge: Experience with sterile or injectable products is highly advantageous.
- Vendor Management: Proven ability to work effectively within outsourced regulatory models.
Core Competencies
- Independence: Ability to execute complex regulatory activities with minimal supervision.
- Strategic Judgment: Strong critical thinking skills used to navigate risk-based decision-making.
- Detail Orientation: An uncompromising commitment to accuracy and documentation quality.
- Agility: A proactive approach to managing shifting priorities in a global, fast-paced framework.
