Associate Director, Regulatory Affairs Labeling - Ireland
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- The Associate Director Regulatory Affairs Labeling will be responsible for regulatory support (both technical and operational) in the area of product labeling for our company.
- This position reports to the Head of Global Labeling and will be responsible for key functions including creating, updating and maintaining labeling documents throughout the product life-cycle, with primary focus on Company Core Data Sheets and products marketed globally.
- The candidate will help maintain controlled records for historical labeling changes, and communicate labeling changes to stakeholders at the time of implementation.
- As needed, the candidate will also help to implement process improvement changes to increase the efficiency and effectiveness of the label review process.
- This position will interact cross-functionally with members of commercial, legal, safety, medical, and others.
- 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
- Maintain controlled records for historical, current, and ending labeling changes, and communicate labeling changes to stakeholders at the time of implementation
- Manage quality control over entire labeling process and management of revisions, including assigning/tracking projects, workflow execution, and issue resolution
- Under the direction of the Head of Global Labeling, assist in implementing process improvements to increase the efficiency and effectiveness of the label review process
- Work closely with Regulatory Affairs colleagues and Supply chain colleagues
- Provide project management to the Labeling Team throughout the entire process, from the decision to update a CCDS/USPI/SPC through notification to stakeholders, to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements
- Responsible for proofreading and departmental QC work
- Lead the development of CCDS, package inserts and equivalents and their associated Patient Labeling Documents
- When developing new labels, research the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text, including contingency strategy development for negotiation with regulatory authorities.
- Support the Head of Global Labeling in providing development and guidance to Labeling Managers and Senior Labeling Managers.
- As assigned, provide leadership to various process improvement projects.
- B.S/B.A. (or equivalent in industry related experience)
- Proven experience in regulatory affairs with particular focus on labeling
- Experience associated with global product labeling regulations strongly desired
- Strong judgment and decision making skills
- Excellent written and verbal communication skills
- Ability to review regulatory labeling documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies
- Must be able to work successfully within a team/partnership environment and as an individual contributor, with a high level of professionalism
- Ability to interact effectively with all levels/roles of project team members
Description of Physical Demands
- Responsibilities may require working outside of “normal” hours, in order to meet business demands
- Ability to travel occasionally