Regulatory Affairs and Quality Manager

1 week ago

South East England, United Kingdom Page Group Full time

The local role is essential for Scientific Affairs to stay close to its most important stakeholders: the customers, patients, consumers and HCPs. **Client Details** My Client is a fast growing pharmaceutical business who own and commericialize branded, orginial over the counter products and prescription medicinies. Products are available in more than 60 countries with EU and Nordic region as the core markets. Due tocontinious growth and recent acqusitions we are looking for a Scientific Affairs Manager to join the team. UK HQ based in the South East of England. **Description** Regulatory Affairs And Quality Manager RA: - Manage launch compliance execution - Responsibility for the local product information and timely roll-out of label updates into the local market, including updates to texts, submission as applicable and implementation following approval. Duties are performed in collaboration and with supportfrom Global functions. - Review and approval of local labeling (mock-ups) of the products - Maintenance of local databases - Coordinate local regulatory activities for UK, IE, CA, AU/NZ, ZA and MT as instructed by the Global team - Maintain/renew CPNP registrations in UK - Act as direct contact with UK Notified Body for medical devices marketed in UK. - Work with the global RA CHC (consumer healthcare) team towards compliance of the CHC portfolio on the UK market according to UK regulations for medical devices and cosmetics. QA: - RP on the UK WDA. Responsible for MHRA communication and compliance. Responsible for sourcing the import and RPi activities which will be outsourced. - Assist the senior management with the strategic goals of obtaining and maintaining a Wholesale Distribution authorisation for Great Britain to allow them to import Qualified Person certified medicines from the European Economic Area. PV: Govern Patient Safety interest in local marketing activities and mentor a vigilant mind set. Ensure that Local PV takes part in local brand teams "centre of attention". - Register with MHRA as the National Contact Person (NCP) for Pharmacovigilance. - Act as the nominated Local PV Contact Person (LPV) in the designated territory UK and Ireland. - Act as the CA contact person for PV in respective territory - Collection and assessment of case reports (AE and other safety information) from various sources, translating, and forwarding to HQ in accordance with stipulated timelines - Identification of safety-related publications in the local scientific literature - PV intelligence locally - Supporting maintenance of the UK PSMF - Ensuring BCP locally and annual testing **Profile** Regulatory Affairs And Quality Manager - 2 years experience within a pharmaceutical distribution environment - Formal GDP training - 5 years experience of local Pharmacovigilance - Experience with Regulatory Affairs procedure and variation management - Professional verbal and written communication skills - Enjoy solving problems and mediate issues that may arise - Structural sense and good documentation skills with ability to work towards and reach set up goals. - Ability to lead & train others **Job Offer** Competitive Basic Salary + Package

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