Reference Number: JO-2009-454554
Regulatory & Medical Affairs Manager
Job Type: Contract
Role: Regulatory and Medical Affairs Manager
Location: Surrey fully remote until next year & then from next year, 3 days homeworking offered
Salary: highly competitive + benefits
employment: 18 months FTC potential to go permanent
Regulatory Professionals are collaborating with a multinational pharmaceutical company who is focused on contributing toward improving the health of people around the world through the pro-vision of innovative and reliable pharmaceutical products. Their core therapeutic areas include On-cology, Nephrology, Urology, Transplantation and Anti-infectives.
Our client are seeking an experienced Medical Affairs professional who is a ABPI Final Signatory to join the UK Regulatory team on a fixed term contract basis for 12-18 months, to be the SME for the Specialists Brands & Urology product portfolio, ensuring the provision of appropriate regulatory services, compliant with their policies, EU and local laws and guidance, as necessary for the com-panys activities in the UK.
Embed Compliance Culture across all Regions of the business ensuring Integrity in Action is ac-tively applied in all initiatives. Ensure Medical and Regulatory Affairs Function(s) strictly adopt a culture of ethics and compliance; leading by example and appropriately challenging non-compliance.
Ensure adherence to our clients policies relating to Ethics and Compliance standards and in-teractions with Healthcare Professionals (HCPs), Healthcare Organisations (HCOs) and Patient Organisations (POs).
Review and approve promotional materials complying with ABPI, MHRA and applicable inter-nal regulations and/or policies.
Participate in brand teams, representing regulatory affairs in cross-functional meetings e.g. brand planning, launch meetings.
Drafting and updating RA quality documents (SOPs) or guidance document
Training other shareholders on main learnings from MHRA vetting process or other topics re-lated to promotional review.
Organizing cross-functional meetings with promotional material reviewers when needed (i.e. risk assessment).
Ensure strategic and operational alignment of RA activities with e.g. Marketing, Sales, Market Access & Pricing and reimbursement and Supply Chain departments to allow the commercial and Supply Chain departments to anticipate and plan product registrations and belonging launches.
Maintain a high level of expertise about UK and EU regulatory procedures and requirements. Ensure that local regulatory requirements intelligence to full extent is monitored, applied and communicated within RA-Established markets and within the affiliate.
Understand and interpret scientific data and make recommendations.
Responsible for ensuring current regulatory product information is available to internal and external stakeholders at all times.
Ensure SmPCs are maintained and relevant notifications are made in a timely manner accord-ing to local processes.
Produce regular overviews for relevant personnel of upcoming variations that impact on com-pany product information.
Receive regulatory related our clients global and regional policies and SOPs and ensure appro-priate affiliate staff are notified and trained on, applicable SOPs
Back up for regulatory submissions and maintenance of external databases necessary for op-eration of the department (i.e. electronic Medicines Compendium/, Chemist & Druggist, In Demand).
Take ownership of Regulatory or company projects as required.
Develop and maintain professional relationships with relevant external contacts such as gov-ernmental bodies and pharmaceutical industry association, where appropriate.
Ensure that regulatory review and approval of (abbreviated) prescribing information and pro-motional materials are conducted as mandated by our client procedures and UK legislation.
Skills & Experience Required
Extensive pharmaceutical medical department experience
ABPI Final Signatory
Relevant degree or equivalent (e.g. pharmacy/pharmacology, life sciences, chemistry or simi-lar)
A challenging and diversified role
Good career opportunities
Inspiring and collaborative work climate
Attractive remuneration package
If you would like to apply for this position, please contact Amani via firstname.lastname@example.org. If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers *terms and conditions apply*