Senior Director of European Regulatory Affairs
Senior Director of European Regulatory Affairs
Permanent position – Full Time
Competitive salary and excellent corporate benefits
Our client is seeking a Senior Director to manage registration and post registration activities for all products in Europe by collaborating with Central Dossier Team/Respiratory Team/Regional RA team and R&D and with EU Business function, Quality function, Supply chain, legal functions to facilitate achievement of business priorities to obtain MAs and commercialisation with quality and supply chain and drug safety compliance.
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Role and Responsibilites
Act as a single point of contact for all stakeholders of the organisation to depend on for region-specific regulatory requirements and technical support in order to provide regulatory guidance and advice to support to the stakeholders in their decision making.
Participate in portfolio and project management meetings and discussions with input on strategy and regulatory requirements and intelligence.
Liaise with business to ensure input of critical factors to have products that can be commercialised on time in markets required
Assist with obtaining Scientific Advice from European Authorities as appropriate
Participate in launch meetings. Report on status of filings. Input on quality and manufacturing requirements that will impact launch and any supply chain matters including EU import, testing and batch release requirements.
Provide guidance to the team for the gap analysis activities
Track the filing timelines required due to IP and for business imperatives by liaison with IP and Business and regulatory intelligence to understand any changing requirements and capacity at different EU regulatory Authorities which could impact assessment timelines such as choice of RMS.
Provide guidance to EU RA team to plan submission strategy with appropriate procedure and as needed creative strategies
Review all proposed in-licensing agreements and proposed out-licensing agreements (including divestment of MAs) for Europe and advise on strategy and collaborate with all functions, especially legal and business to ensure input regarding the suitability of deals are evaluated and have suitable terms in agreements that are favourable for out-licensing maximise the value of any assets.
Monitor web-sites for regulatory guidelines and updates
Active participation in trade associations (Medicines for Europe) and professional bodies (Pharmaceutical Society and The Organisation of Professionals in Regulatory Affairs) to network and have good intelligence within the pharmaceutical industry
Network with Regulatory Authorities to have good relationships to facilitate good support and information availability
Share and disseminate information to EU RA team and other functions and regulatory intelligence team
Ensure files/databases that reflect up to date registration status is maintained by the team so that the business/cross functional teams have visibility of the registration status/portfolio of the region.
Participate in internal business reviews/ strategyProvide regular reports and data and information as required to Head of Regulatory Affairs and senior management
Evaluate tasks and processes and systems that could be more efficient or improved and look for innovative options or some incremental improvement for those processes and systems
Track and ensure awareness to comply with updated Authority systems – especially within IT.
Support EU RA team to implement revised systems and processes
Evaluate training needs of EU RA team and identify opportunities – in house training and external training as appropriate
Regular reviews with team to be conducted to evaluate strengths and weaknesses and so support and ensure strengths are optimised
Provide training on a regular basis as needed (to QA) or on an ad-hoc basis to new employees to the EU business regarding European Regulatory Affairs
Prepare a budget of filing and maintenance costs and associated regulatory costs as needed
Monitor spending wrt budget throughout the year and advice of changes or potential deviations
Approve all regulatory cost payments
Register as company director for EU-located companies with support of company secretaries
Perform required duties of the company director with the cooperation of the company secretaries and finance and other functions related to these roles
Skills & Knowledge
B.Pharm. M.R.Pharm S or a relevant science or pharmaceutical science degree
Overall minimum experience of 15 years of European Regulatory Affairs including new product submissions and post-approval activities of generic products with at least 10 years in a managerial position leading a team. Experience of direct interaction with European Regulatory Agencies and Assessors
If you are interested and feel you have the right skills or wish for a confidential discussion then please apply to this role.
Gi Group Pharmaceuticals provides a tailored Account Managed Service and dedicated Pharmaceutical recruitment team and partners with many different Pharmaceutical and Biotechnology clients throughout the globe and the United Kingdom.