Regulatory Affairs Officer

Location
County Waterford
Salary
Dependent on Experience
Posted
11 Jan 2019
Closes
08 Feb 2019
Ref
J5630744
Contact
Georgia Walden
Contract Type
Permanent
Hours
Full Time
An exciting Regulatory Affairs opportunity has become available to join a Leading Pharmaceutical company based in Co. Waterford in Ireland. You would be joining the company as a Regulatory Affairs Officer and will assist with the registration of Small and Large molecule products as well as Generics to Global markets including the US, EU and Japan. You will also have to opportunity to support regulatory activities focused on new drug development as well as Clinical and Bioequivalence studies.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Regulatory Affairs Officer will be varied however the key duties and responsibilities are as follows:

1. Life Cycle Maintenance of current product licences held by the company and their clients.

2. Support licensing activities of existing Marketing Authorisation Application ( MAA ) to new market regions across in the EMEA, FDA and other rest of world markets.

3. You will prepare dossiers for submission through liaison with R&D, QC and manufacturing teams as well as external partners as required.

4. You will assist with the strategic regulatory planning for a wide variety of product types across human and animal health.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Regulatory Affairs Officer we are looking to identify the following on your profile and past history:

1. Relevant degree in a Life Sciences discipline (e.g. Chemistry, Pharmacy, Pharmacology, Biology etc.) in addition to any experience in a Pharmaceutical / Biopharmaceutical industry.

2. Proven industry experience within Regulatory Affairs including knowledge of EU and US regulations for submission as well as clinical trial legislation.

3. A working knowledge and practical experience with cGMP and cGCP pharmaceutical manufacturing as well as an understanding of pharmaceutical product development.

Key Words: Regulatory Affairs | Pharmaceutical | Biopharmaceutical | EU | US | EMEA | CTA | IND | Clinical Trial | Life cycle management | GMP | GCP | Solid Dosage Forms | Steriles | Inhalation | Marketing Authorisation Application | MAA

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.

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