My client, a London based pharmaceutical company, are currently searching for a Regulatory Officer / Senior Officer to join their team based in South West London. Within this role you will ensure the appropriate licensing of assigned products and development projects in order to control their safety and efficacy, in line with the company business objectives, relevant regulatory requirements and internal and external standards.
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.
Ensure the maintenance of regulatory databases and departmental filing systems to facilitate accurate and retrievable records of department activities.
Provide regulatory input on artworks and ensure approval in time for product launch and compliance with legislation and guidelines.
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.
Support the PV and Medical Information function by providing assistance to ensure pharmacovigilance activities performed are completed in a timely manner ensuring compliance and mitigation of risk.
Support company Quality System, to ensure compliance with policies and procedures, and with local regulatory requirements.
Comply with relevant legal and compliance requirements, regulatory and ethical standards and company SOPs.
Qualifications and Experience:
Degree in a suitable scientific discipline (biological/chemistry/life sciences)
Basic knowledge of local and European regulatory affairs/PV legislation and guidance
Planning and organisation skills- ability to multitask
Able to work under pressure and to strict deadlines
A confident credible communicator with good negotiation skills
Good written communication skills with attention to detail.
In depth knowledge of local and European regulatory affairs/PV legislation and guidance
Substantial regulatory experience across the full product lifecycle
Broad experience of managing relevant regulatory submissions, with demonstrated ability to work independently and manage complex projects.
Able to build relationships at all levels of the business
Excellent written communication skills with attention to detail.
Ability to handle multiple tasks/projects and manage priorities accordingly.
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email a copy of your CV to email@example.com