Regulatory Affairs Manager
- Experience Level
On behalf of our client, an expanding pharmaceutical company based in the South East we are actively recruiting for a Regulatory Affairs Manager.
To support the Head of Scientific Affairs with activities associated with the registration of products (Human and Veterinary) in Worldwide markets including US, EU and Japan, as well as Regulatory Compliance liaison with QA for registered products.
To lead and develop the Regulatory team. Supporting the Clinical Affairs teams (Human and Vet) for Regulatory approvals for clinical trials globally as required.
To ensure that project plans and milestones are delivered according to agreed timelines and co-ordination of department metrics around same
To ensure department budgets and controls spending in line with Corporate approved annual budgets
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.
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.
Education & Experience:
B.Sc. Ideally 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
Skills & Behavioral Competencies:
1. Familiarity with cGMP in pharmaceutical manufacturing
2. Significant experience of Regulatory Approval processes for pharmaceutical products globally
3. Technical knowledge of analytical/ formulation development of pharmaceutical Products (e.g. solid oral dosage forms, biologics, fill finish, inhalations)
4. People management/leadership skills
5. Multi-tasking- ability to manage conflicting deadlines
6. Good planning and organizational skills
7. Working knowledge of EDMS (Electronic Document Management System)
1. Planning and organising - effectively develop and implement plans to accomplish project objectives.
2. Communication - write, speak and present information effectively across communication settings.
3. Adaptability - maintain effectiveness in varying environments and with different tasks, responsibilities and people.
4. Problem Solving/Analysis - secure relevant information and identify key issues and relationships from a base of information; relate and compare data from different sources, identifying cause-effect relationships.
5. Teamwork and Collaboration - working effectively with team I work group or those outside the formal line of authority (e.g. peers, senior managers) to accomplish organisational goals; taking actions that respect the needs and contributions of others, contributing to and accepting the consensus; subordinating own objectives to the objectives of the organisation.
6. Customer Service Orientation - making efforts to listen and understand the customer (both internal and external); anticipating and providing solutions to customers’ needs giving high priority to customer satisfaction.
7. Initiative making attempts to influence events to achieve goals; self-starting rather than accepting passively; acting to achieve goals beyond what is required; being proactive.
For full details and job spec email your CV to firstname.lastname@example.org or call +353 1 2784671