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Senior Manager, Regulatory Operations

United Kingdom - Cambridge, United Kingdom - UxbridgeRegulatoryRegular

Job Description

Senior Manager, Regulatory Operations

Gilead is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Job Overview:

  • As a member of the Regulatory Operations team, this position manages the submission, compilation, and publishing activities associated with generating complex hard copy and electronic submissions within Regulatory Operations.

  • Performance management of direct reports, to include but not limited to biannual performance reviews, goal setting, leave approval, sick leave acknowledgement, SOP compliance tracking, regular 1-1 meetings.

  • Managing projects with high complexity.

  • Line management of Associate and Manager level staff.

Job Responsibilities:

  • Manages staff for their areas of expertise and accomplishes results mainly through senior associates and associates.

  • Responsible for medium-term forward planning of publishing resources (up to 1 year out). Has an awareness of long-term filing plans (more than 1 year) and advises senior management of resource implications.

  • Coordinates activities associated with generating paper/electronic EU centralized and Swiss regulatory submissions, including, project and timeline planning, workload assignment and oversight of publication activities.

  • Acts as a Therapeutic Lead for Regulatory Operations, building and maintaining strong relationships with the Regulatory TA Team.

  • Interfaces with Regulatory Operations globally to ensure technologies, processes and required resources are in line with global Gilead business objectives. Follows and interprets FDA, EMA, SwissMedic and ICH guidelines for electronic submissions.

  • Actively collects, manages and actions Regulatory Intelligence

  • Applies quality control processes to ensure submission integrity.

  • Guides the successful completion of major initiatives.

  • Contributes to the design, development, and implementation strategies for dossier management and planning.

  • Manages multiple projects. Reviews documentation for, and maintains oversight of, the status of multiple projects managed by junior colleagues. Maintains constructive and positive interactions with colleagues.

  • Follows up on and discusses the status of ongoing projects with the team, sets expectations and provides support where necessary and reports on project statuses to senior management. Takes decisions regarding issue resolution.

  • Represents the organization as a technical contact for projects of any complexity.

  • Acts as a technical expert with exceptional detailed knowledge, understanding and broad contextual awareness associated with generating regulatory submissions and formatting documents.

  • Acts as department point of contact for Stakeholder relationships and engagement.

  • Co-ordinates and manages routes of communication between stakeholders and Regulatory Operations

  • Manages staff for expertise from Associate to Manager.

  • Can assist with the coordination of non-routine projects as applicable.

  • Can assist with onboarding of acquired companies and their staff

  • Can assist with strategies of acquired companies with process or additional projects.

Knowledge & Skills:

  • Must have excellent verbal, written, extensive organizational and time management skills and a strong attention to detail.

  • Is able to prioritize and balance multiple tasks simultaneously to achieve goals and satisfy customers.

  • Must be able to manage work projects effectively within an environment that has quickly changing processes, priorities, and deadlines.

  • Demonstrates an in-depth knowledge of eCTD.

  • Demonstrates strong interpersonal skills in all situations

  • Demonstrates strong project management skills, with the ability to manage the tasks of more junior associates.

  • Expert technical knowledge of current systems (Word, Acrobat, document management system, Document Processing supporting tools)

  • Understanding of RIM strategy and systems and software setup and implementation supporting this

  • Demonstrates excellent people management skills with the ability to motivate, support and lead a diverse team

Education & Experience:

  • Demonstrable relevant experience

  • Experience in document management and Regulatory publishing is required.

  • An in-depth familiarity with pharmaceutical development and global Regulatory submissions is required.

Location

Cambridge or Stockley Park (Uxbridge)