Cache of job #13790071

Job Title

Regulatory Affairs Officer

Employer

Morgan Mckinley

Location

Dublin

Description

Responsibilities: The job will involve but will not be limited to the following: Maintenance of approved marketing authorisation (MA) dossiers through submission of variations, renewals, follow-up measures and PSURs. Preparation of the above submissions in collaboration with other departments and partner companies. Preparation of responses to regulatory authority queries. Publishing of regulatory submissions using eCTD Manager software. Review and approval of product artworks to ensure compliance with the relevant MA. Interactions with the Corporate office and partner companies and provision of documentation required to support the MAs they have responsibility for. Maintenance of the company's manufacturing licence by submission of any necessary variations to the HPRA. Regulatory compliance activities relevant to the manufacturing site, including review of change controls and GMP documentation (specifications, batch records etc.) Clear communication of the regulatory status of the products to internal and external stakeholders through maintenance of compliance dossiers and circulation of Notices of Regulatory Approval/Event. Requirements: A BSc in a life sciences discipline. At least 1 years work experience in a pharmaceutical role in Regulatory Affairs or at least 2 years experience in a Quality role. Excellent attention to detail. Strong computer and administrative skills. Excellent verbal and written communication skills. Morgan McKinley is acting as an Employment Business in relation to this vacancy. Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide. This job originally appeared on RecruitIreland.com.

Date Added

2419 days ago

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