Senior Regulatory Affairs Advisor
Ref No:TD6358
| Location: |
Limerick |
| Job type: |
Permanent Full-Time |
| Salary: |
Not Disclosed |
| Min. experience req: |
2-3 yrs |
| Consultant: |
Tina Dunne |
Role:
A Senior Regulatory Affairs Advisor is required to work in a well established consultancy company. This is a permanent full time role.
Key Responsibilities:
You will have Ownership/ regulatory responsibility for a portfolio of products and will 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.
You will proposes and implement effective strategies to minimise the timing of and optimise the commercial viability of product licenses from IMB/ EU Competent Authority.
Ensure and maintain product licenses are up to date and fully compliant.
Build and maintain strong relationships with all personnel within the Irish Medicines Board or appropriate competent authority to ensure ease of access and influence.
Requirements:
B.Sc. Minimum or pharmacy primary degree.
Greater than 3 years experience in EU Regulatory Affairs (Pharmaceutical Industry).
Experience with variations, renewal and new applications to the Irish Medicines Board essential
Experience in the Medical Device Sector also an advantage but not a prerequesite.
Strong commercial awareness and an innate ability to assess the commercial implications of decisions and advice.
Rounded knowledge of the national and EU regulatory framework.
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.
Ability to work independently with minimal supervision.
Motivated self-starter.
For more information on these opportunities email their CV to tdunne@thornshaw.com or call Tina on 01-2784671 for further information. For a list of all vacancies please log on to our website www.thornshaw.com.
Contact Information:
