Celgene Associate Director, Global Regulatory Labelling - UK or Switzerland in Stockley Park, United Kingdom

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Summary

You will provide regulatory guidance and oversight of global labelling activities for assigned products and may serve as the Global Labelling Lead on the Company Core Data Sheets (CCDS) and labeling teams, proving strategic input into the development and approval of CCDS, SmPC and USPI for assigned products.

This role is also a Celgene expert on EU labeling requirements and the EMA centralised labelling and translation process and maintains an awareness of the impact on the Company of proposed regulatory changes.

Role and Responsibilities

  • Serve as the Global Labelling subject matter expert for all matters relating to the CCDS

  • Maintain knowledge of US and EU labelling regulations and guidelines

  • Provide leadership in the preparation, maintenance, and finalisation of labelling texts for internal review and approval before submission to regulatory authorities. Solicit affiliate feedback, where relevant, to understand potential linguistic issues and issues impacting reimbursement

  • Ensure compliance with current EU and US regulations, guidance and templates

  • Ensure labelling complies with the CCDS and deviations are identified and managed appropriately for assigned products

  • Act as the Subject Matter Expert for EU/US Regulatory Labelling guidance and answer any technical or procedural queries relating to them

  • Liaise with Readability Testing company to initiate and monitor progress of projects on consultation with target patient groups

  • Assist in the review and response of global HA queries relating to labelling

  • Manage the process for providing translations of Product Information (PI) in multiple languages (centralised procedure) within strict European Medicine Agency (EMA) procedural timelines, ensuring compliance with EN PI and language-specific Quality Review of Documents (QRD) templates/guidelines and terminology

  • Versions, archives and distributes final PI for internal use

  • Responsible for review and compilation of change control workflows for updates to labelling text and artwork for assigned products marketed in EMEA

  • Manage electronic archiving of draft mock-ups and label texts, and packaging artwork, including version control and archiving

  • Manage the development and maintenance of the core abbreviated product information documents

  • Liaise with Product Lifecycle Management teams to progress labelling content into printed packaging materials

  • Update XEVMPD database for assigned products

  • Support Regulatory inspections and internal audits

  • Contribute to or lead activities on the creation and update of labelling processes

  • Support Manager in the training and development of other team members

Skills and Knowledge required

  • Bachelor's degree in a scientific discipline or closely related field

  • Experience in the pharmaceutical/ biotechnology industry

  • European Regulatory labelling experience

  • US Labelling experience desirable

  • Excellent writing, editing and proofreading skills with attention to detail

  • Expertise in developing labelling content

  • Experience working with translation vendors and working with the CP linguistic review process

  • Expertise in QA change control system

  • Knowledge of regulatory requirements on packaging information

  • Understanding of Electronic Document Management Systems to a sufficient level to support labelling documentation

  • Confident with data input for document management systems

  • Ability to prioritise workload and handle multiple projects

  • Demonstrated ability to interact effectively with cross-functional teams and regulatory agencies

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COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE