Job Description
Our client, an international pharmaceutical company based in Dublin, now seeks a Senior Regulatory Affairs Specialist who will manage and coordinate various regulatory activities throughout the life cycle of a pharmaceutical projects and products globally. This role will have office presence in Dublin, however there is also flexibility to work from home some days per week.
The successful candidate will provide project-specific Regulatory Strategic advice, technical expertise and coordination oversight for assigned projects. Additionally, this hire will liaise directly with Regulatory Agencies as required.
The ideal candidate will be a Regulatory Affairs Specialist who is experienced in dossier preparation and management, and other regulatory compliance activities. This role will suit a professional who is ambitious to develop and who is adaptable to the changing nature of a busy environment.
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Responsibilities for Senior Regulatory Affairs Specialist:
Review current registration dossier for all marketed products to identify and record dossier completeness, formatting issues, compliance with guidelines / legislation, on-going regulatory issues and outstanding regulatory commitments.
Maintain assigned products’ Marketing Authorisations via timely variations and renewals submissions and their approvals.
Ensure timely preparation and compilation of registration dossier for assigned projects in accordance with EU and international standards
Ensure meeting registration timelines, via timely response to queries from Health Authorities’ and deficiencies as well as via close cooperation with other involved functions and liaison with Regulatory Authorities, where required.
Direct / mentor other RA individuals assigned to support projects of responsibility, as appropriate.
Participate in project launch meetings, review meetings and project team meetings as required.
Build departmental awareness of local regulatory requirements in EU and international markets and provide regulatory advice, guidance and support to all project teams, as required.
Support compilation of regulatory component of annual product quality reviews.
Establish and maintain system for tracking changes in documents submitted to agencies or partners.
Requirements for Senior Regulatory Affairs Specialist:
Bachelor of Science Degree in Chemistry, Pharmacy or related Life Science discipline.
3+ years of applicable experience in quality and regulatory teams, within cGMP pharmaceutical manufacturing.
Experienced in maintaining Marketing Authorisations, managing variations and renewals submissions and their approvals through process.
Attention to detail and quality of documentation.
Ability to handle multiple projects.
Analytical and investigative skills, with ability to interpret data.
Good judgement and decision-making skills.
Effective oral and written communication skills.
Good interpersonal skills and ability to work in team environment.
Familiar with computers and their applications, e.g. Word, Excel, Power Point.
Please phone Larry on +353 (0)1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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