Regulatory Affairs Specialist II

Integration Liaison Role

Bausch + Lomb is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better. Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

Objective: Integration liaison role between Global/Regional/Local RA and cross-functional team members to streamline, manage and track all integration projects and coordinate post-integration RA activities such as integration of products through acquisition, technical transfers and geographical expansion projects on behalf of the Global Regulatory Affairs department.

Responsibilities

Responsible for general knowledge of pharmaceutical, consumer and medical device regulations in Regional and Local markets. Partners closely with cross-functional stakeholders to document registration strategy and implementation plans while ensuring regulatory compliance. Communicate with stakeholders to manage project priorities, deadlines, and budgets to meet organizational and department objectives. Coordinate with cross-functional team members, to ensure that all departments are working together effectively. Coordinate the transfer of information, internally and/or externally to support project needs. Manage the individual activities of a project team according to the overall plan. Develop project plans and budgets, including timeframes for each phase of a project and cost estimates. Ensure that all project documentation (such as meeting minutes and project plans) is accurate and up to date. Coordinate with other groups working on different aspects of the project to ensure that they are on schedule and adhere to standards and regulations. Manage partner relationships and communication with internal and/or external partners to ensure satisfaction with project results.

Qualifications

Minimum Associate's degree, Bachelor's degree preferred (or equivalent). Minimum 1.5 years of Regulatory Affairs Project management experience. PMP Certification preferred.

Skills/Knowledge

Excellent organizational and communication skills; both oral and written. Strong organizational skills and excellent in managing multiple priorities. Ability to prioritize projects, coordinate multiple projects simultaneously and work with tight deadlines. Self-motivated and capable of working independently with minimal supervision. Proficient skills in basic technologies (e.g., MS Office Applications, Adobe Acrobat Pro, Smartsheet, MS Project, etc). Detail oriented with the ability to proofread and check documents for accuracy and inconsistencies. Command of English language (verbal and written). Ability to work and contribute to a team environment. Knowledge of good documentation practices.

We offer competitive salary & excellent benefits including: Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date. 401K Plan with company match and ongoing company contribution. Paid time off vacation (3 weeks - prorated upon hire), floating holidays and sick time. Employee Stock Purchase Plan with company match. Employee Incentive Bonus. Tuition Reimbursement (select degrees). Ongoing performance feedback and annual compensation review.