Description
Senior Regulatory SpecialistMy client is a leading API manufacturing pharmaceutical company based in North Dublin and they are currently recruiting for a Senior Regulatory specialist. As the senior regulatory specialist you will be responsible for maintaining regulatory aspects of the company's drug substance in accordance with the guidelines laid down by national regulatory authorities and managing any associated change controls.
You will be responsible for preparing and maintaining regulatory aspects of manufacturing license/authorisation for the company in accordance with the guidelines laid down by national regulatory authorities (e.g. IMB, EMA,) The Senior Regulatory Specialist will assist the Quality function in maintaining the manufacturing authorisation and in performing batch release and brokering activities
Supporting the International Regulatory Manager at the companies affiliate that acts as Marketing Authorisation Holder for the group's pharmaceutical drug products in the preparation and maintenance of marketing authorisations (where appropriate) for designated territories in accordance with the guidelines laid down by national regulatory authorities
As the Senior regulatory specialist your role will also involve supporting the QA team in relation to Regulatory Affairs and Compliance in the context of the Group Quality Management System. You will also be responsible for maintaining an oversight of the registration requirements and activities in relation to other classes of products i.e. medical devices, cosmetics, biocides or medical foods both existing and arising from Business development
The Senior Regulatory specialist role will involve:
Preparing and despatching suitable dossiers and data to designated registration agencies (EU and non EU) or licensees/customers to agreed company procedures and objectives
Reviewing data to ensure suitability for submission
Registering new products in new territories in line with the company's marketing plans
Renewing and updating manufacturing licences/authorizations
Processing product licence and manufacturing authorization variations as required.
Updating regulatory documents according to agreed company strategies
Establishing and maintaining contact with key personnel in the various Regulatory agencies and within the Group
Obtaining information and keeping up to date on regulatory rules and guidelines prepared by National Regulatory Agencies
Other activities relating to Clinical support, Product Development Support, Database administration, Budgetary planning and control
Experience required:
Degree in a science discipline, e.g. BSc or MSc or equivalent.
Minimum of 3 years experience with a pharmaceutical or similar organisation.
Experience with and a good understanding of the Regulatory Compliance activities.
Excellent communication skills and ability to express themselves clearly both verbally and in writing -
Excellent technical skills, the ability to analyse and interpret complex issues and make evidence based decisions.
Excellent interpersonal and professional skills to interact with different cultures (Mostly in CEE) and at all levels within the organisation
Excellent organisational and time management skills,
Strong work ethic
Ability to work in environments with continuous change, challenges and ambiguity.
Well-developed leadership and project management skills
Some ability to travel abroad as required (mostly to CEE) to support auditing of affiliates and suppliers.
This is a really exciting opportunity which gives you variety and a high level of responsibility and exposure to many different areas. It is a very senior role and one where you will really get to develop and progress your career.
There is an excellent benefits package and an excellent salary of between €50,000 and €58,000 on offer plus occasional remote work is an option.
If you are interested in this position please apply now for immediate consideration.