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Senior Specialist, Regulatory Projects Team
Other Locations:Stockley Park, UK 1 Longwalk Road Stockley Park Hillingdon UB11 1DBDescriptionSupports execution and delivery of EU regulatory strategy for assigned projects. Supports the building of regulatory dossiers to achieve timely regulatory approvals and maintenance of the existing product portfolio. Liaises with Regulatory Affairs (RA) Projects Team management and with other internal/external stakeholders.
* Supports the execution of development and submission strategies in the EU for assigned projects, by contributing to the development of high quality regulatory dossiers (e.g., scientific advice requests, orphan medicinal product designation applications, MAAs and variations), ensuring compliance with regulatory requirements.
* Contributes to the content of regulatory documents working with other functions as necessary and contributes to the review of documents before submission.
* May support the regulatory aspects of clinical trials and liaise with individuals with CTA or CRO oversight responsibility.
* Supports the delivery of Content Plans to allow publishing and timely dossier submission.
* Responsible for; tracking activities, projects and timelines, managing deliverables and for accurate submission plans in eQRMS
* Identifies and communicates to manager, any emerging issues that may impact Celgene's business.
* Ensures that copies of regulatory documents such as contact reports with regulatory agencies are archived.
* Identifies any learning or best practice and communicates to manager.
* Responsible for developing knowledge of current EU regulatory guidance and procedures.
* International travel may be necessary
* Bachelor's degree in scientific discipline or equivalent required.
* Pharmaceutical industry experience required and experience of Regulatory Affairs preferred
* Basic understanding of current EU regulatory processes preferred.
* Developing understanding of CTD modules; non-clinical, CMC, Clinical
* Good understanding of core processes of drug discovery, development, manufacturing and marketing preferred.
* Developing understanding of therapeutic area for projects assigned
* Eager to learn and take on new initiatives
* Effective time manager. Delivers projects in accordance with timelines
* Acknowledges others who take the initiative to try new approaches even if the results are not perfect
* Can identify when to escalate issues to line management and knows when to seek advice.
* Communicates with clear messaging
* Understands contributions of other departments and external stakeholders
* Exhibits consistent professional behaviours