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Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek dedicated individuals who share our sense of urgency, unity, and excellence.

We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future.

We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact.

OBJECTIVES/PURPOSE OF JOB Labeling Manager is responsible for leading labeling artwork projects for the development of new and changes to existing product labeling components for Pharma, Consumer and Medical Device products.

KEY ACTIVITIES/RESPONSIBILITIES

• Manages labeling artwork projects for the development of new and changes to existing product labeling components (including package inserts, medication guides, patient/pharmacist information inserts, directions for use, instructions for use, container labels, and cartons, etc.)

• Provides labeling component artwork files to support initial submissions and post approval labeling changes

• Evaluates content of labeling on all labeling component artwork to ensure compliance with regulatory requirements and company guidelines (Branding, Trademarks

• Collaborates and facilitates review and approval processes with appropriate cross-functional teams (such as Regulatory Affairs Product Lead, CMC, Graphics, Legal, Quality, Supply Chain, Marketing, R&D, Engineering) and external parties to develop new or update existing labeling component artwork

• Monitors, evaluates and recommends improvements to labeling process, systems, tools and/or procedures.

• Review new labeling for accuracy and for other regulatory requirements.

• Liaise with Regulatory Affairs members and other cross-functional teams to ensure the accuracy of all information included on the label or in the labeling.

• Support the review process and coordinate with other Regulatory functions for the submission, approval and notification of new/revised labeling content.

• Develop and maintain tools/lists that support the coordination with other functions (eg: Quality, manufacturing) to make certain only agency approved labels are produced for appropriate products.

• Monitor changes to Referenced Listed Drug (RLD) products.

• Support Regulatory leads by creating labeling documents for FDA submissions.

• Other job responsibilities as needed.

TECHNICAL COMPETENCIES:

• Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product lifecycle including Development, Commercialization, and Operations.

• Knowledge of FDA regulations relating to submissions and regulatory approval of drug products.

• Knowledge of pharmaceutical industry product labeling processes for review and obtaining regulatory approvals.

• Strong technology skills and abilities, especially with Microsoft Office programs and web-based programs.

• Ability to critically and efficiently review detailed information to support a labeling revision.

• Strong technical knowledge of drug listing and SPL.

PROFESSIONAL COMPETENCIES:

• Demonstrated ability in analytical reasoning and critical thinking skills.

• Ability contribute and lead a team environment.

• Ability to understand and apply business drivers outside of Regulatory Affairs

• Strong communication skills; both oral and written

• Strong interpersonal skills with the ability to influence others in a positive and effective manner.

• Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies – able to do so quickly without sacrificing attention to detail.

EXPERIENCE:

6+ years relevant pharmaceutical industry and regulatory experience

3 + years’ experience within pharmaceutical labeling

Bachelor’s degree required

Applied knowledge of FDA labeling requirements

Familiarity with XML concepts including structured product labels (SPLs) preferred

As required by law, Bausch Health provides a reasonable range of compensation for roles that may be hired in the US. Actual compensation is influenced by many factors including skill set, level of experience, and specific office location. For this role, the range of starting pay for this role is $110-130k.

Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.

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This position may be available in the following location(s): [[location_obj]]

Bausch Health Companies Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.

If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to humanresources@bauschhealth.com or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number.

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Bausch Health is an EEO/AA employer M/F/D/V.