REGULATORY AFFAIRS SPECIALIST (PHARMA)
Tom Devaney of CareerWise Recruitment requires a Regulatory Affairs Specialist for a Galway based client.
Contact Tom Devaney on +353-91-758771 for more information
CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times.
1. Life cycle management and regulatory filing maintenance activities;
* Preparation, review and submission of supplements to existing approvals (with guidance from Senior Regulatory Specialist/ Regulatory Manager).
* Monitoring the progress of regulatory submissions, responding to queries and ensuring that approvals are granted without undue delays.
* Preparation, review and submission of Annual Reports for ANDAs/NDAs. This also includes the review of documents, utilizing the change control database to ensure accurate reporting and tracking FDA acknowledgements.
Assess and review documentation to ensure compliance with product licences.
* Recommend the appropriate regulatory reporting mechanism using FDA regulations, guidance documents and in-house policies and procedures upon review of Change Control Documentation. Track and monitor change controls using Trackwise Change Control system.
2. New Product Submission Activities;
* Preparation of registration submissions, in CTD format, for approval by the US FDA, European Regulatory Authorities and worldwide, as required (with guidance from Senior Regulatory Specialist/Regulatory Manager).
* Monitoring the progress of registration submissions, responding to queries and ensuring that registration approvals are granted without undue delays.
* Establish and maintain positive working relationships with internal and external partners to facilitate efficient accomplishment of regulatory and site goals.
* Actively participate in project teams, as required.
* Make updates to departmental procedures to foster an environment of continuous improvement.
* Perform other duties as assigned.
* Minimum of a Bachelor's degree (or equivalent) in a science related discipline and 1-2 years? regulatory experience in the pharmaceutical industry. However, a combination of experience and/or education will be taken into consideration.
* Topra certification or RAC, preferred.
* Good knowledge of the USP, 21 CFR and various FDA Guidance?s for Industry.
* Knowledge of cGMP awareness and compliance.
* Knowledge of sterile products and their regulatory requirements.
* Excellent communication skills, both oral and written.
* Experience in writing and submitting regulatory documentation.
* Technical background.
* Strong organizational skills.
* Accuracy and attention to detail.
* Strong work ethic.
* Ability to respond quickly to a changing regulatory environment.
* Computer skills, E-mail (Lotus Notes), Microsoft Word, Excel, Powerpoint an advantage.
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Specialists in the recruitment of
Senior Management, Commercial, Technical/Engineering, Supply Chain & IT personnel
Supporting Business Demands & Growth since 1999