Description
A branded international Pharmaceutical company in Dublin is seeking a Senior Regulatory Affairs Officer to be part of their team.Main duties:
- Prepare, compile and submit new product applications through national, mutual recognition or decentralised procedures
- Update existing product dossiers to current formats and progress applications through national, mutual recognition or decentralised procedures
- Preparation of responses to queries from regulatory agencies on new applications and existing products in conjunction with relevant personnel.
- Preparation of variation applications to support changes to registered details.
- Preparation and/or updating of product labelling in accordance with regulatory and marketing requirements.
- Perform due diligence on file acquisitions and provide assessment reports
- Update / maintain internal databases in relation to the status of on-going tasks.
- Provide regulatory compliance information within the company in relation to change control, packaging specification, product labelling, and Product Quality Review requirements.
- Keep abreast of industry related regulatory legislation and trends in order to provide appropriate guidance / direction on regulatory compliance.
- Represent the Regulatory Affairs Department at inter-departmental meetings.
- Act as representative at meetings with the different National Regulatory Authorities.
- Any other key tasks as may be reasonable requested by the Regulatory Affairs Manager
Requirements:
- A third level degree in a scientific discipline
- 5 years Regulatory Affairs experience within the EU, and in a Pharmaceutical or related industry environment.
- Strong Formulation and Analytical skills. The applicant should demonstrate proficiency in terms of compiling robust Part II submissions.
Highly Desirable:
An Agricultural/ Veterinary back-ground
Previous experience in R&D or Quality Control.
An excellent salary and benefits package is on offer. For immediate consideration call me, Olivia Doggett, on . Otherwise apply directly to this advert.