Senior Associate, Regulatory Affairs Labeling Compliance - Endo : Job Details

Why Endo?

We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.

The Regulatory Affairs Labeling Senior Associate is a key member of the Regulatory Affairs Labeling team and will report directly to the Regulatory Affairs Labeling Director. The Regulatory Labeling Senior Associate will be responsible for the development/revision of labeling content along with the review and approval of all Regulatory Labeling text documentation for Labeling Updates (SLC, RLD, FDA Letters) for all Endo sites. The Regulatory Labeling Senior Associate will be expected to work in an environment that requires strict adherence to procedures necessary to ensure error-free labeling and FDA submissions.

• Coordinate all labeling development, reviews, and approvals through the RA labeling group.
• Review of regulatory documentation pertaining to NDA, ANDA and post approval submissions for labeling revision verification.
• Proofread and review in-house and vendor proofs for labeling components for all Par sites, Third Party and special projects.
• Review the Labeling section of NDA and ANDA Annual Reports.
• Review all Brand and Generic Structured Product Labeling (SPL) documents for each Regulatory Labeling Submission.
• Prioritize workflow to meet critical timelines which are consistent with departmental and company objectives.
• Work closely with the Graphics Department regarding all in-house artwork.
• Monitor graphic development of relative labeling components for all generic products.
• Provide support to internal departments, customers and vendors pertaining to labeling requests, inquiries, issues, and responses.
• Support implementation and use of documentation systems/tools, e.g. Docuproof.
• Work with cross functional team members both within Endo and with Partner Companies.

Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.

EEO Statement:

At Endo we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.