Local Regulatory Affairs Manager

The Local Regulatory Affairs Manager Ensure regulatory compliance and delivery of the local regulatory milestones for a defined range of products of the Bayer portfolio. Oversee IT requirements to submission standards, Oversee 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. Ensure alignment to country requirements and internal SOPs.  

 Major Tasks and Responsibilities:

• Ensure local Regulatory compliance
• Contribute to the good company image and to the company
• Quality Management
• To manage Group IT needs and implementation of new IT technology/software to optimize RA operations in order to meet GRA electronic submission/publishing requirements.
• To advise and assist Regulatory team members in the electronic submission of registration
• To manage group expenditure, provide supervisor budget information and carry out budget forecasting/resource planning in line with controlling processes in cooperation with supervisor.
• To manage group finance systems, liaison with MHRA regarding all invoicing queries and management of annual registration fees process.
• Manage 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
• Manage legal contracts to ensure supplier contracts are prepared according to template, are updated in a timely manner as required and availability of all local/country RA contracts in Efilia.
• Ensure appropriate archiving process in place and carried out to meet company compliance standards.

 Work relations:

• ·         Health Authorities ( registration, labeling, promotion, clinical activities)
• ·         HTA bodies ( Pricing)
• ·         PCT
• ·         Third parties
• ·         Global and regional Regulatory affairs
• ·         Country Commercial Lead
• ·         CPD Manager
• ·         Marketing/ Sales
• ·         Supply chain
• ·         Country PV head
• ·         Packaging Developement
• ·         Local Quality Representtaitive

    Who you Are:

• ·         Ph.D. or M.Sc. degree in life science.
• ·         Experience in a national and / or regional registration procedure.
• ·         Leadership , communication and negotiations skills
• ·         Commercial awareness, good project management skills and an ability to adapt to changing priorities
• ·         Knowledge of national and regional pharmaceutical regulatory
• ·         Languages: English, French , Arabic