Pharma Solutions Recruitment Specialists

Regulatory Affairs Manager - Pharmaceuticals - Dublin - December 2019 - Urgent

Our client, a major pharma company based in Dublin currently have a vacancy for an experienced Regulatory Affairs Manager to play a leading part in their Medical Affairs Department.

This is a permanent full-time position. The position will report into the Head of Medical

Purpose:

Ensure regulatory compliance and delivery of the local regulatory milestones for a defined range of ethical products for Ireland and also MT as relevant. Contribute to IT requirements to submission standards, contribute to local OI updates to ensure compliance standards and training are maintained in line with local standards and global SOPs. Manage electronic and paper archiving systems ensuring alignment to country requirements and internal SOPs

Key Tasks:

Ensure local Regulatory compliance by:

• Timely, in good quality and properly documented submission of labelling changes based on the CCDS according to pharma SOPs
• quality related changes according to the agreed timeliness
• DSURs according to SOP and the local legislation
• applications for new Marketing Authorisation, line extensions and new indications
• renewals in order to keep Marketing Authorisations valid in the country- (if applicable)
• educational materials, DHPCs and other risk minimisation activities according to SOP and HPRA guidelines
• other documents and information as required
• Regular monitoring of the submission status with the authorities, contributing to the preparation of answers to deficiency letters and other Authority requests in cooperation with GRS/EPM, documenting all relevant contacts in a factual manner, checking of incoming documents and initiating their correction, if needed.
• Timely update of internal and external databases and document management systems (like BRAIN, Contact database, ShareDoc, local compendia etc.), providing relevant information on RA milestones to GRA and other functions on the local level (Medical, Pharmacovigilance, Product Supply, Business, Communication, Market Access, etc.).
• Timely implementation of approved labelling and CMC changes into the packaging materials according to SOPs and the local legislation.
• Archiving of all documents and correspondence submitted to and received from the Authority according to the Global SOP and locally agreed processes.
• Adherence to the global and local Standard Operating Procedures and Operational Instructions.
• Contribute to the good company image and to the company success by:
• Timely delivery of regulatory milestones in line with the EU and national objectives.
• Open and transparent communication with the local Authority, prompt reactions to their requests and documentation of thereof in the respective database (e.g. Contact database, BRAIN).
• Monitoring of the local legislation and competitive environment changes, promoting awareness of regulatory requirements within the company, influencing legal landscape via local networking.
• Contributing to the development of strategies that meet both regulatory and commercial objectives, contributing to the successful products’ launches.
• Quality Management:
• Contribute to ensures that all local procedures comply with global directives and procedures, as described in the procedure on review and implementation of global directives
• Provides support in the preparation, conduct and follow up of inspections as described in the procedure on Inspection Management
• Give needed RA support to Quality Manager to perform the investigations and CAPA, as described in the procedure on investigation and CAPA management
• Writes, reviews and approves documents applicable to his department, as described in the procedure on SOP management
• Ensures that the correct texts are used for the packaging materials as described in the procedures on repackaging and extra labelling activities
• As an ad-hoc member of the PQSC, as necessary, provide support in the management and organization of a recall, as described in the SOP Recall handling
• Provides guidance on regulatory obligations and company policies for the management of self-inspections, as described in the SOP Self-inspection
• As an ad-hoc member of the PQSC, as necessary, support the process of handling of safety and quality crises
• Has overall responsibility for the publication of SmPC and PIL for allocated products on the regulatory product information databases
• To implement new IT technology/software to optimize RA operations in order to meet GRA electronic submission/publishing requirements.
• To advise and assist other Regulatory team members in the electronic publishing and submission of registration packages according to HPRA requirements.
• To provide supervisor resource planning in line with controlling processes in cooperation with supervisor.
• Contribute to local/country OI/SOPs to ensure preparation and maintenance of local documentation according to local requirements and in-line with Global SOPs to meet inspections standards.
  
  Qualification & Competencies:
• Requires a Ph.D., M.Sc. or B.Sc. degree in life science or pharmacy.
• Experience in a national and/or regional registration procedure.
• Minimum 2 years’ experience as a Regulatory Affairs Manager in Pharma
• Fluency in English.
• Requires adequate negotiating, interpersonal and influencing skills.
• Commercial awareness, good project management skills and an ability to adapt to changing priorities
• Knowledge of national and regional pharmaceutical regulatory requirements.

An excellent salary plus bonus and strong benefits package will be offered to the successful candidate

For further information, please contact Paul Flanagan at Dublin or e mail your c/v in the strictest confidence to paul@pharmasolutions.ie asap