Senior Regulatory Analyst

SRG are currently looking for Senior Regulatory Analyst for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team on an initial 6 Month basis to be based at their offices in Berkshire.

The Role: Supports the implementation of registration strategy for assigned products in the Europe Region. Supports assigned product maintenance and lifecycle management submissions. Supports clinical trials strategy as required. Has some experience with regulatory procedures and contributes to the effective functioning of the Europe Region Regulatory Affairs team. Contribute, as required, in the development of regional processes. Develops and maintains knowledge of regulatory procedures and environment within the region.Key Responsibilities: Responsible for ensuring that teams and functional groups are provided with clear, constructive regulatory advice and intelligence.  Plans and implements regulatory activities in support of lifecycle management and maintenance in the region. Supports co-ordination of the review of CMC, QRD, PSUR and labelling submissions and approval of product-related packaging. Provides appropriate Europe Region regulatory input to project teams. Ensures planned drug development activities comply with guidelines. Makes recommendations to Global Regulatory and drug development teams.  Supports the drug development strategy.  Defines Europe Region filing strategy (including CP, MRP, DCP); identifying risks and issues. Responsible for implementing and ensuring effective planning, tracking, archiving of activities.  Supports the communication of regulatory strategy in support of new product registration.  Follows core GRA policies and procedures.  Support implementation of new processes and input into changes in processes.  Provides forecasts and actuals and manage in line with regional requirements. Follow all approved regional procedures and guidance. Skills/Experience Required:Education and Experience Graduate in Life Sciences in a relevant area. Some knowledge of both pharmaceutical regulations and guidelines and national regulations within the assigned region. Prior relevant experience in pharmaceutical industry or Regulatory Affairs Essential Skills and Abilities Ability to plan and organise workload including managing multiple projects. Ability to work effectively and collaboratively across the Allergan organisation. Good interpersonal and negotiation skills. Good communication skills, both written and verbal (in English). Willingness to travel as necessary. Computer literateIf you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: corinne.laurence@argtalent.com or +441615077288