Regulatory Affairs Manager (Pharma)
Regulatory Affairs Manager (pharma) - County Waterford. In this role you will support the Head of Scientific Affairs with activities associated with the registration of products 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. Support the Clinical Affairs teams for Regulatory approvals for clinical trials globally as required. Ensure that project plans and milestones are delivered according to agreed timelines and co-ordination of department metrics around same. Ensure department budgets and control spending in line with Corporate approved annual budgets. Core Responsibilities: 1. Project Planning/Co-ordination. Together with the Head of Scientific Affairs, 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. Together with the Head of Scientific Affairs, 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. 2. Regulatory Compliance. Oversee licence maintenance support to customers, Regulatory agents and internal departments. Regulatory Compliance liaison with QA. 3. Licensing Activities. Manage licensing activities for existing Marketing Authorisation applications in Europe, US, Japan, Canada and various markets in South America, Asia and the Middle East. 4. Dossier preparation. Manage submissions to target markets, including liaison with R&D, QC, and Production as well as external experts where required. 5. Strategic planning. Strategic planning of regulatory activities in target markets for products. 6. Leadership. Coaching/mentoring- support members of team with problem solving and skills development to aid learning and early problem resolution. 7. Recruitment- assist with recruitment of team members in line with resource requirements on to job specification. 8. Manage regulatory affairs budget and cost centre activities. Interested applicants should have: B.Sc. primary degree in Chemistry, Pharmacy or Pharmacology or other 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 (e.g. solid oral dosage forms, biologics, fill finish, inhalations. People management/leadership skills. Multi-tasking ability to manage conflicting deadlines. This job originally appeared on RecruitIreland.com.
40 days ago