Regulatory Affairs Manager

ICDS Recruitment

Waterford

Regulatory Affairs Manager. Key Purpose: The ideal candidate will be required to support the Head of Scientific Affairs with activities associated with the registration of company products (Human and Veterinary) in Worldwide markets including US, EU and Japan, as well as Regulatory Compliance liaison with QA for registered products. You will lead and develop the Regulatory team. Supporting the Clinical Affairs teams (Human and Vet) for Regulatory approvals for clinical trials globally as required. The ideal candidate will ensure that project plans and milestones are delivered according to agreed timelines and co-ordination of department metrics around the same. Also ensuring that department budgets are met and control spending in line with Corporate approved annual budgets. Key Responsibilities: Project Planning/Co-ordination. Actively plan regulatory requirements ensuring major milestone targets for each product are visible to all team members and key stakeholders to achieve on time market entry. Determine tasks and resources required to deliver each project milestone and deliverables. Work with the Clinical Affairs team to support clinical trials by direct responsibility for activities associated with the clinical trials including Regulatory approvals and IMP management. Regulatory Compliance. Oversee licence maintenance support to customers, Regulatory agents and internal departments. Regulatory Compliance liaison with QA. Licensing Activities. Manage licensing activities for existing Marketing Authorisation applications in Europe, US, Japan, Canada and various markets. Dossier preparation. Manage submissions to target markets, including liaison with R&D, QC, and Production as well as external experts where required. Strategic planning. Strategic planning of regulatory activities in target markets for company products. Leadership. Coaching/mentoring- support members of team with problem solving and skills development to aid learning and early problem resolution. Recruitment & Finance. Assist with recruitment of team members in line with resource requirements on to job specification and manage regulatory affairs budget and cost centre activities. Qualifications & Experience. Minimum B.Sc. Ideally primary degree in Chemistry, Pharmacy or Pharmacology but any Science related discipline considered. At least 10 years Regulatory affairs experience to include responsibilities in supervisory/people management. Familiarity with cGMP in pharmaceutical manufacturing. Significant experience of Regulatory Approval processes for pharmaceutical products globally. Technical knowledge of analytical/ formulation development of pharmaceutical Products. Working knowledge of EDMS (Electronic Document Management System. This job originally appeared on RecruitIreland.com.

1801 days ago