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Recruitment Associate - shane.robinson@bakerfinn.com
Regulatory Affairs Officer
Cork (Onsite preferably, open to up to 2 days onsite/3 remote)
Responsibilities include:
* Preparation and submission of new Marketing Authorisation applications
* Maintenance of approved marketing authorisation dossiers including submission of variations, renewals and follow-up measures
* Preparation of the above submissions in collaboration with other departments and partner companies
* Preparation of responses to queries from regulatory authorities and partner companies
* Publishing of regulatory submissions using eCTD Manager Software
* Review and approval of product artworks to ensure compliance with the relevant MA
* Interactions with management and partner companies and provision of documentation required to support the MAs they have responsibility for
* Regulatory compliance activities related to the manufacturing site, including review of change controls and GMP documentation (specifications, batch records, etc.)
* Maintenance of Manufacturer’s Authorisation and Wholesale Distribution Authorisation
* Maintenance of regulatory forms, logs, and databases with up-to-date regulatory information
GMP
* Cognisance and compliance with all the necessary elements of process paperwork including Standard Operating Procedures, system logs, stock control systems, machine logs, process documentation and specifications
* Responsible at all times for plant and process hygiene within the area of operation
* Vigilance for product or process defects and the reporting of same
* Co-operate in all respects with the correct dress wear required in the area of operation
* Co-operate with the strict level of personal hygiene required for pharmaceutical operations
Safety
* Operate all machinery in a safe and effective manner taking care to comply with all the safety mechanisms of the machine designed to protect the operator
* Make sure that plant housekeeping is maintained at all times
* Faulty or unsafe equipment is reported and rectified
* Protect the individual by wearing the correct equipment (at all times) necessary for the operation at hand
* Co-operate with the training programs instituted by the company, also the training of new employees
* Co-operate with any outside agencies or contractors as required by the company
* Co-operate with any medical screening program required by the company
* Co-operate with all elements of the company procedure for work and discipline
* To contribute in a positive manner to the overall development of the company
* To act as a professional for the organisation
* To work as part of a larger team
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Manufacturing
* Industries
Pharmaceutical Manufacturing
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