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Would you like to work for a global leading organization where you have a voice, are respected and can influence, and a chance to experience real career growth. Then we are the company for you. We are a multi-billion dollar leading pharmaceutical organization exploding with growth and launch multiple new therapeutic areas of focus.
We are searching for a Senior Manager, Global Regulatory Affairs - Labeling
The Senior Manager, Global Regulatory Affairs, Labeling will be responsible for regulatory support in the area of product labeling. 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 webpages, 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 our 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.
- 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
- Manage external graphic designers as appropriate for creation of packaging artwork .
- Lead and manage more junior labeling roles as required.
Required Knowledge, Skills, and Abilities:
- Minimum of 5 years' experience in the pharmaceutical industry, with 4 years as direct experience in Global Labeling.
- 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
- 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.
Required/Preferred Education and Licenses:
- B.S/B.A. (Science or Health Science)
Environment and Physical Requirements:
- Responsibilities may require working outside of “normal” hours, in order to meet business demands
Ability to Travel:
- Occasional travel is required
endevis, LLC. and all companies represented are Equal Opportunity Employers and do not discriminate against any employee or applicant for employment because of age, race, color, sex, religion, national origin, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state or local protected class.