101695
Compliance Officer RA Executive Compliance Executive Regualtory Affairs Executive
Dublin North Dublin South Dublin West
25000 - 35000
1 - 2 Years
Permanent Full-time
Third Level Degree
Ciaran McArdle
dublin@brunel.ie
Regulatory Affairs Officer - Dublin South
A leading multinational pharmaceutical manufacturers require an experience Regulatory Affairs Executive to join there their team
Your duties will include, but will not necessarily be confined to:
- Prepare, compile and submit, new product applications through national, mutual or decentralised procedures
- Update dossiers to mutual recognition standard and progress through national, mutual or decentralised procedures
- Preparation of responses to queries from regulatory agencies on new and existing products in conjunction with relevant personnel.
- Preparation of renewal applications.
- Preparation of variation applications to support changes to authorised details.
- Preparation and/or updating of product literature in accordance with regulatory and marketing requirements.
- Update / maintain internal databases in relation to the status of on-going tasks.
- Provide regulatory compliance information within the company in the company in relation to change control, packaging specification, product literature, and Product Quality Review requirements.
- Filing and retrieval of regulatory information
- Keep abreast of all regulatory legislation and trends in order to provide appropriate guidance / direction to internal and external stakeholders on all areas of regulatory compliance.
- Any other tasks as may be reasonable requested by the Regulatory Affairs Manager
PERSON SPECIFICATION
Primary degree within a scientific discipline.
EXPERIENCE
At least 1-2 years regulatory affairs / compliance experience with the Pharmaceutical or related industry
PERSONAL ATTRIBUTES, SKILLS AND EXPERIENCE
Excellent organisational skills with the ability to prioritise and manage projects within a team environment.
Excellent communication skills both written and verbal
A keen eye for detail and accuracy
Good interpersonal skills, building strong working with relationships with stakeholders both internal and external.
Self motivated with the initiative and resourcefulness to successfully see projects through to completion
CORE COMPETENCIES
Technical Knowledge
Data Analysis and Innovative Thinking
Building and Maintaining Relationships
Communication
Personal Adaptability / Energy / Resilience
Contact Ciaran McArdle today for immediate interview dublin@brunel.ie +353-4321510