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Regulatory Affairs Manager

Employer
Thornshaw Recruitment
Location
Waterford (County), Munster (IE)
Salary
Negotiable
Start date
17 Jun 2019
Closing date
3 Jul 2019

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Discipline
Regulatory Affairs, Compliance
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

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:
Skills
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)

Competencies
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 tdunne@thornshaw.com or call +353 1 2784671

Company

thornshaw-title

Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment.  In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.

Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.

Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.

Our Industries

We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years. 

Our Specialities

Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.

Our Mission

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For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com

 

Company info
Website

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