Director of Regulatory Affairs required for global pharmaceutical company based in London.
Location: London AreaOur client, a global pharmaceutical company, has a vacancy for a Director – Regulatory Affairs to join the organisation.Your responsibilities will include the following: You should have experience in the following areas: Application detailsFor further details, please contact Samantha on 01438743047. If this vacancy is not exactly what you are looking for why not give us a call, we may be dealing with a vacancy better suited to your needs.About us Finding a new job can be a rather daunting process, at CK Clinical we pride ourselves In our honest and supportive approach. This is the reason why nearly 50% of people we help are referred to us by their colleagues and friends. CK Clinical are preferred suppliers to the top 5 global organisations within our sector aswell as having agreements in place with smaller, more niche organisations too.If you expect more than just a great salary and benefits package and believe you can make an impact in this innovative and cutting edge business then please contact Samantha Ng on Tel: +44 (0)1438 743047 who specialises in this field. Email: firstname.lastname@example.org
Work for a Global Pharma
Lead regulatory strategy
Play a vital role in developing the department
Effectively liaise, negotiate and partner with European Regulatory Agencies and EMEA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects.
Liaise, negotiate and orchestrate meetings and teleconferences with National Regulatory Agencies and EMEA; strategise and plan for Regulatory Agency meetings; capture key communications via contact reports.
Manage the preparation, assembly and publishing (as required) of all regulatory documents (MAAs, CTAs, Amendments etc) in paper and electronic format in accordance with European Directives as well as National requirements.
Participate in global product team meetings (for products assigned); by applying regulatory expertise and knowledge of European requirements provide strategic input, regulatory support and guidance.
May support global regulatory or technical initiatives or act as a regional representative in a cross-functional initiative.
Collaborate with all disciplines within the organisation to obtain and/or provide information/data for regulatory submissions.
Mentor/instruct and provide guidance to internal and external direct/in direct reports including consultants and CROs as well as plan, assign and direct work; managecompeting priorities as appropriate
Review and interpret regulatory guidelines.
Review RA and related documents for approval.
Knowledge and support of electronic publishing, electronic submissions and electronic document management systems.
Ability to manage and coordinate several global projects simultaneously.
Ability to liaise, negotiate and interact with worldwide regulatory agencies; orchestrate meetings and teleconferences; document interactions between the company and Regulatory Agencies.
Ability to provide managerial direction and regulatory guidance.
Ability to build team relationships and interface in a global team environment at all levels of management.
A thorough understanding of the submission processes: complete CTAs/MAAs including amendments and variations (coordinating, managing, preparation and assembly of its components, and publishing a final quality submission) CTA annuals reports; adverse events etc
Comprehension of Regulations, Directives and guidelines; comprehension of GMPs, GLPs and GCPs.