SENIOR REGULATORY AFFAIRS OFFICER
Our client is a global healthcare company that specialises in lifesaving medicines and technologies. They are looking to appoint a Senior Regulatory Affairs Officer, reporting directly to the Head of Regulatory Affairs.
The position is responsible for the day-to-day management of medicinal product regulatory licensing activities (MAA's and all national post authorisation activities) along with oversight and management of the Enteral Nutrition Borderline Substances range with ACBS and DHSC submissions.
To assist in the day to day management and allocation of workload within the department in addition to mentoring and coaching of the regulatory team where required.
Preparation and submission of regulatory post authorisation activities, such as variations, renewals, new MAA's to MHRA and HPRA.
Oversight and management of the enteral nutrition borderline substances to ACBS and DHSC
To assist in the management of the regulatory budget / invoicing activities, including tracking of all regulatory expenditure and budgetary spend.
Assess provided supporting dossier documentation to ensure adequacy and accuracy for submission.
Maintain effective communication between the company and the regulatory authorities during assessment of applications to obtain prompt approval.
Maintain effective communication between corporate and regional regulatory colleagues to obtain necessary information / data for regulatory submissions.
Assess promotional material against ABPI Code of Practice and relevant national requirements.
Assess licensed product labelling to ensure compliance with legal and corporate requirements.
Provide a professional, responsive and efficient service at all times.
To undertake other reasonable duties as assigned by the Head of Regulatory.
EXPERIENCE & QUALIFICATIONS REQUIRED:
A Scientific degree or an equivalent will be required for this position.
Demonstrable experience gained in a Regulatory Affairs role.
The ability to build solid internal and external relationships.
Strong communication and interpersonal skills.
Due to the high volume of applications we receive we are not able to get back to everyone who applies. Therefore if you have not heard back from Experis within 7 days please assume that your application has been unsuccessful however we will contact you if suitable roles come up that match your skill set.