Director Regulatory Labelling
Our client is a biopharmaceutical company focused on improving patients' lives in the therapeutic areas of hematology and oncology. The company is seeking a Director, Regulatory Labelling to join their team in Reading, UK on a full-term basis.
- Responsible for the leadership and oversight of labeling for products marketed globally.
- Serves as an internal expert on the content of Core Data Sheet and local labels and labeling (including EU SmPC and RoW Product Information).
- Representing the labeling perspective and applying expertise and organizational influence with cross functional teams and will work collaboratively with the Clinical, Medical, Legal, Compliance, Safety, Commercial Quality and Supply Chain
- Lead, develop and manage employees and resources needed to support Global labeling activities to support business needs, including oversight of staffing, personnel development and training, as well as management of resources and budget.
- Accountable for ensuring the completion of key labeling functions with primary focus on Company Core Data Sheets and regional/local labeling for products marketed globally.
- Provide regulatory consultation and strategy to business functions during development of target product profiles for development programs as well as for labeling development needs
- Oversee the entire labeling process, from the decision to update a CCDS/SmPC for assigned product(s) through implementation of changes of local package inserts and equivalents and their associated Patient Labeling Documents, to ensure that labeling documents are reviewed, approved and produced in a high quality and timely manner according to internal SOPs and external regulatory requirements
- Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations as they pertain to the development/maintenance of labeling: and advise key stakeholders on the application of these labeling principles, including recommendation of policy and/or process changes as needed
- Provide strategic advice in the development of labeling text, including contingency strategy development for negotiation with regulatory authorities
- Support regional and local affiliates by developing a network of regulatory and medical contacts, acting as consultant in regulatory and code compliance matters, supporting local affiliates in promotional complaints, supporting the development, integration and update of local affiliate processes and standards for promotional material review and determining the training needs for International stakeholders
Education, Skills and Experience:
- Minimum of 10 years of increasingly responsible experience in the pharmaceutical industry, including at least 6 years of direct experience in Global Labeling and 3 years of experience in other regulatory affairs function(s)
- Extensive experience and knowledge in labeling and product information (including labeling texts for artwork content), including superior working knowledge of applicable SmPC Guideline and QRD requirements and practice.
- Strong judgment and decision-making skills
- A proven track record of effective collaboration with regulatory agencies.
- A proven record of effective collaboration with cross-functional teams.
- Evaluative, analytical, and interpretative skills, enabling review and synthesis of reports and other documents used in promotional regulatory strategy and submissions.
- Ability to travel occasionally - approximately 10-20% regional and/or international travel
- Responsibilities may require working outside of "normal" hours, in order to meet business demands.
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