Quality/Risk Management, Regulatory Compliance, Submission & Registration, US Regulatory Affairs
Available to sit in Philadelphia, PA or Palo Alto, CA.
The Senior Manager, Global Regulatory Affairs, Labeling will be responsible for regulatory support in the area of product labeling for Jazz Pharmaceuticals. This position reports to the Associate Director/Senior Director, Global Labeling and will be 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. This position will help maintain controlled records for historical labeling changes, and communicate labeling changes to stakeholders at the time of implementation. As needed, this position will also support the implementation of process improvement changes to increase the efficiency and effectiveness of labeling processes. This position will interact c with Regulatory Affairs colleagues and interact cross-functionally with members of the Clinical, Medical, Legal, Safety, Commercial, Quality and Supply Chain organizations.
Maintain expertise regarding key labeling requirements worldwide and stay current with labeling regulations and guidance 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 proposed labeling changes, including labeling compliance activities (management of product information on corporate labeling web pages, as well as participating in audit and inspections as required).
Communicate labeling changes to stakeholders at the time of implementation, including PRA and Medical Information colleagues
Maintain awareness of regulatory legislation pertaining to labeling; assessing and communicating the impact on Jazz business and products.
Manage quality control over entire labeling process and management of revisions, including assigning, tracking projects, workflow execution, and issue resolution.
Assist in implementing process improvements to increase the efficiency and effectiveness of the label review process in collaboration with the Labeling Operational Excellence team.
Provide project management to the Labeling Team throughout the entire process, from the decision to update a CCDS/USPI/SmPC or other labeling document (including patient information labeling such as Med Guides, IFUs, PIL) through to implementation into printed materials, to ensure that labeling documents are produced in a timely manner according to internal SOPs and external regulatory requirements. Responsible for proofreading and departmental QC work.
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.
Schedule, coordinate and lead LC meetings, schedule and coordinate ELC endorsement Lead and manage more junior labeling roles as required.
Required Knowledge, Skills, and Abilities
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 verbal and written communication skills and collaborative interpersonal 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
Some travel required.
Responsibilities may require working outside of "normal" hours, in order to meet business demands.
Required/Preferred Education and Licenses
Bachelor degree minimum, Masters, or other advanced degree in a scientific discipline preferred (or equivalent in industry related experience)
Minimum of 5-7 years’ experience in the pharmaceutical industry, with 4 as direct experience in Global Labeling or 3 in other regulatory affairs function(s).
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
Internal Number: 4213
About Jazz Pharmaceuticals
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.