Director, Regulatory Affairs Global Labeling in London

This position is responsible for the development, review, and management of US, EU, and International labeling for commercial products. The manager will ensure the appropriate labeling strategies are communicated to project teams; compliant with core labeling and local regulations; ensure the labeling is accurate and of the highest quality; and support implementation of approved labels which may include change management records, document control, QCing documents, translations and verification of translations, and tracking project milestones and status. The person that will be joining the team will become part of a developing team that is going through a strong period of growth.

RESPONSIBILITIES

• Preparation of labeling content based on source documents such as CSRs, regulatory requirements and other reference documents.
• Review worldwide labeling against the Core Company Safety Information and facilitate and track implementation of Core Labeling changes.
• Assist with the management of CCDSs.
• Document control and distribution of product labels including drafting initial documents, annotations, generate and review of SPL files, prepare final labeling.
• Project management role of logistical activities and delivering labeling documents within agreed timeframes.
• Facilitate the review and approval process within the product labeling teams, including outlining the label history and documentation of team decisions.
• Provide and maintain background documents outlining the purpose and justifications for labeling changes.
• Work collaboratively with members of the Labeling Strategy and Implementation Team and other cross functional departments to resolve issues and drive execution of deliverables.
• Ensure content of labeling text is verified and maintain version control.
• Manage approved labels in a label management database/corporate system to ensure accurate and up to date labeling is available and accessible at all times.
• Maintain knowledge of current rules and regulations governing global labeling activities.
• Receive and collate labeling text from labeling team members and manage labeling content and revision control.
• Assess text for compliance with labeling requirements and provide team recommendations on appropriate text for labeling content.

EDUCATION

• A degree in life sciences.
• External labeling training/certificates.

EXPERIENCE

• The role requires an individual with substantial bio-pharmaceutical Industry experience with a strong track record in Regulatory Affairs.
• Experience with direct management of labeling projects and related activities is essential.
• US and EU Labeling experience minimally required with international labeling and core labeling experience highly desired.
• Proven experience in providing labeling review teams direction and guidance on labeling content, verbiage, and submission requirements worldwide.
• Experience with global labeling processes and review of Company Core Safety Information.
• Experience in review process, standards, and industry best practice pertaining to labeling.
• Strong scientific background and/or experience to quickly establish therapeutic area working knowledge.
• Working knowledge of medical terminology and drug safety.
• Experience and working knowledge with SPL and PLR requirements.
• Proven project management, leading teams from multiple functional areas.
• Experience processing and assessing translations of labeling documents to ensure the content is identical to English approved text.
• Must be able to work as a team member and independently.
• Strong attention to details required and high quality work.
• Experience with MS Word, Adobe Acrobat, Excel, MS Project and other tools used in labeling.

Note: This description is not intended to be all-inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.