Shire's strategic goal is to become the most valuable specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. We aspire to imagine and lead the future of healthcare, creating value for patients, physicians, policymakers, payors and our shareholders.
Shire is listed on NASDAQ & London Stock Exchange (LSE) In 2011 total revenues increased to $4 billion growth - sales increased 26% .Shire is the largest growing FTSE 100 company past 2 years running . We have ambitious plans of continued growth for the future.
Shire is a global company with offices in the major pharmaceutical markets. Its UK offices are in Basingstoke and its US offices are in Pennsylvania, Massachusetts and California. Our products are marketed in over 50 countries worldwide, and we have offices in over 29 countries across Europe, America's & Asia Pacific.
Due to company growth, Shire is now recruiting a Regulatory Affairs Manager to join our UK team, based in Basingstoke. This is a great opportunity to join a growing and successfulteam and be part of Shire's future success, with excellent opportunities for further progression for the right individual.
The Regulatory Affairs Manager serves as a project team regulatory liaison for investigational and marketed products
Responsibilities
* Offers strategic and operational regulatory support to preclinical, clinical, manufacturing, quality assurance and marketing departments.
* In collaboration with senior management and regulatory project strategy teams, develops and reviews regulatory strategy for operational efficiency.
* Negotiates and makes agreements on behalf of the department.
* Interprets applicable regulations and guidelines for project team use. Keeps project team abreast of regulatory decisions, issues, potential problems and new regulations.
* Serves as a primary contact to the local health authority (HA(s) and facilitates communication between the HA(s) and the project team. Attends and generally leads agency meetings.
* Ensures timely submission of appropriate regulatory documents in conjunction with Regulatory Operations, individually or through subordinates and/or contract organizations.
* Coordinates and solicits components of the submission from various functional areas.
* Proactively raises major project issues to senior management for resolution and agreement.
* Attends Shire advisory panel meetings, investigator meetings and kick-off meetings as required.
* Mentors and/or manages other Regulatory Managers, Regulatory Associates and other junior level or administrative Regulatory staff.
* Maintains a high level of professional expertise through familiarity with scientific literature and participation in training courses.
* Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
The successful candidate willhave a Bachelor's degree. Scientific/health care field preferred, but not required. Have related experience within a pharmaceutical company, CRO or similar organization. The regulatory experience should be broad to match the "generalist" regulatory model within Shire.
This is the chance to join a highly supportive team that believes in delivering to the highest standard but where a work-life balance is key. The team has a proven track record of internal progression and development and Shire has a well defied Talent Management Programme that assists and develops our employees.
Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.
