Regulatory Affairs Specialist

This is a permanent position.

Roles/Responsibilities:

1. Regulatory responsibility for a portfolio of products & is responsible for close liaison with key personnel of the relevant business unit in the definition of product strategies in line with timeframes for approval.
2. Proposes & implements effective strategies to minimise the timing of & optimise the commercial viability of product licenses from IMB/ EU Competent Authority.
3. Protects the assets of company within their responsibility by effectively & proactively managing emerging issues which impact the competitiveness of the licenses. Maintains product licenses up to date and fully compliant.
4. Builds & maintains strong relationships with all personnel within the IMB (Irish Medicines Board) or appropriate competent authority to ensure ease of access and influence.
5. Be an authority on the regulatory framework in Ireland and Europe.
6. Supports EU regulatory initiatives and issues as appropriate.

Skills/Experience:

Must be qualified to degree level & have no less than 3 years experience within the Pharmaceutical arena along with a proven track record in dealing with a lot of variations & renewals & be familiar with submissions with the IMB.
Knowledge of European procedures, DCP's MRP's & be familiar with managing a large & busy product portfolio along with a strong commercial awareness & an innate ability to assess the commercial implocations of decisions & advice.  
You must also have the ability to project manage across a diverse & complex portfolio of products & priorities. 
Excellent written & oral communication skills & have the ability to work independently with minimum supervision & be a motivated self-starter.

Education/Professional Qualifications:

Applicants must be qualified to Degree level.
Have no less than 3 years experience witin Regulatory Affairs within the Pharmaceutical Industry.

To apply in confidence for this position please contact Maeve Lawlor in Brunel Recruitment on 056 7720388 or email your cv to : jobs@brunel.ie