My client, a small generics pharmaceutical company is looking for a Regulatory Affairs officer on a permanent basis.
Ensure the appropriate licensing of assigned products and development projects in order to control their safety and efficacy, in line with company business objectives, relevant regulatory requirements and internal and external standards.
ACCOUNTABILITIES:RELATED PERFORMANCE INDICATORS:
Responsible for the provision of full regulatory support for assigned products across the full life cycle, from pre-launch, launch, maintenance, discontinuation and divestment. Includes the preparation and submission of licence variations, implementation of SPC and pack updates.
Manages increasingly complex submissions making decisions independently and with minimal referral to Regulatory Affairs Manager.
Interacts directly with regulatory authorities on defined matters, liaise with, and make presentations to regulatory authorities on defined matters including negotiating regarding marketing authorisations.
High quality submissions made in line with local and/or corporate timelines and in compliance with local SOPs and defined KPIs.
Collects, collates and evaluates scientific data from a range of sources
Review and submit clear arguments and explanations for new product licences and licence renewals
Performs routine regulatory activities (i.e. maintenance/ renewals/variations)
Follows approval strategy and works proactively to ensure project completion
Recommends changes for labelling, and manufacturing for regulatory compliance
Ensure the maintenance of regulatory databases and departmental filing systems to facilitate accurate and retrievable records of department activities.Activities completed accurately and in accordance with relevant SOPs and defined KPIs
Provide regulatory input on artworks and ensure approval in time for product launch and compliance with legislation and guidelines.
Provide support for marketing material when required
Input is timely, tailored to the audience and shows awareness of the wider business needs
Maintain an up to date and developing knowledge of regulatory affairs legislation and Codes of Practice, with responsibility for completion of assigned training and own development. Apply knowledge within the sphere of own role and in support of the department's activities more widely.
Coaches more junior members of the team.
Regulatory advice given on a range of familiar topics and issues
Timely and accurate input to projects
Represents company at committees and associations and develops knowledge
Shares knowledge and experience to junior members of the team
Support the PV and Medical Information function by providing assistance to ensure pharmacovigilance activities performed at company are completed in a timely manner ensuring compliance and mitigation of risk for company.
Contribute to quality assurance, ensuring that products manufactured on behalf of company and marketed by company comply with EU legislation.
Support company's Quality System, to ensure compliance with policies and procedures, and with local regulatory requirements.
Prepare/review SOP's where required.
If the above is of interest and you feel you have a suitable profile, please apply and get in touch with Ross Wilson at firstname.lastname@example.org for further information.