We offer our staff a dynamic working environment where they get the opportunity to work on projects with the leading pharmaceutical and medical device companies in the world as well as some of the most innovative new entrants to the market. If you are interested in applying for our Regulatory Affairs Consultant vacancy please contact us on 00353 52 61 76706.
This role would suit an individual with previous regulatory affairs experience.
• B.Sc. Minimum or pharmacy primary degree.
• Strong commercial awareness and an innate ability to assess the commercial implications of decisions and advice.
• Excellent written and oral communication skills.
• Ability to project manage across a diverse and complex portfolio of products and priorities.
• Ability to get on with people, to influence people both internally and externally and to achieve objectives.
• Above average attention to detail and solid interpersonal, communication and organisational skills required.
• Excellent attention to detail with client care an integral part of your work ethic.
• Confidentiality and discretion.
• Motivated self-starter.
On a day to day basis the Regulatory Affairs Consultant will:
1. Ownership/ regulatory responsibility for a portfolio of products for nominated client and be responsible for close liaison with the Management/ other key personnel of the relevant business unit in the definition of product strategies in line with timeframes for approval.
2. Maintenance of marketing authorisations for nominated client via a range of regulatory activities including submission of variation applications and MA renewals.
3. Communication with the appropriate competent authority to answer questions and obtain timely approval for changes.
4. Implementation and communication of MA changes. Ensuring all compliance activities are correctly managed.
5. Generation and maintenance of prescribing information, patient information leaflets and packaging components, including artwork management in line with regulatory requirements.
6. Maintain sound knowledge of European regulatory requirements, regulations and guidelines to provide advice and expertise internally for matters related to client products.
7. Provision of guidance/technical support in the preparation of EU CTD dossiers applications.
8. Builds and maintains strong relationships with different Competent Authorities to ensure ease of access and influence.
9. Works collaboratively with other department colleagues to share best practice and information and to ensure a consistent approach with both Competent Authority & within company.
10. Support other team members with the maintenance of the Acorn Quality Management System and ISO 9001, including generation and review of SOPs, reports and other quality documentation.
The role is based at our headquarters in Clonmel, Co. Tipperary. We offer a comprehensive benefits package to our employees and an enjoyable working environment. Get in touch with us today by emailing Brian Cleary at: email@example.com or by calling 00353 52 61 76 706.