Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist - CMC

Des Moines, Iowa

Read the overview of this opportunity to understand what skills, including and relevant soft skills and software package proficiencies, are required.

Bausch + Lomb (NYSE / TSX : BLCO) 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.

Objectives

A member of the global technical CMC team for global regulatory CMC strategy for submissions and content of CMC dossiers for prescription drugs and consumer products.

The team liaises with R&D and Quality organizations to prepare and maintain CMC sections of submissions and respond to Health Authority queries throughout the product lifecycle.

Responsible for regulatory compliance and change management.

Responsibilities

• Proactively communicate CMC regulatory strategy, key issues, and any other critical topics throughout the life cycle to interdisciplinary project teams and to appropriate management levels in Regulatory Affairs, R&D, TechOps, and Supply Chain in a timely manner.
• Lead and drive all CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects / products.
• Identify, as early as possible, the required documentation and any content, quality, and / or timeline issues.
• Coordinate with Regulatory Operations to ensure timely and accurate submissions to Regulatory Authorities.
• Provide regulatory support to other company functions during Regulatory Authority inspections.
• Serve as Regulatory Affairs representative on facility / site Local Change Management Boards.
• Review and provide input on proposed health authority guidance documents on CMC issues.
• Author the annual reports for all non-marketed Rx products independently.
• Provide the CMC portion of Annual Product Reviews (APR’s) for a specified internal manufacturing site.
• Author minor (CBE0 & CBE30) CMC supplements with supervision.
• Work closely and collaborate with CMC Managers & Product Leads on international market requests.
• Actively participate in team activities.
• Act as primary contact with regulatory authorities with limited supervision.

Requirements

• Bachelor degree preferred or equivalent
• Minimum of 3 years Regulatory Affairs experience or relevant experience in a regulated environment
• Excellent communication / interpersonal and writing skills
• Self-motivated and capable of working independently with minimal supervision
• Skilled in basic technologies (e.g., MS Office Applications, Adobe Acrobat, MS Project)
• Knowledge of country regulations (med device and pharma), post market surveillance, ISO and IEC
• Detail oriented with the ability to proofread and check documents for accuracy and inconsistencies
• Command of English language (verbal and written)
• Ability to understand scientific information and assess whether technical arguments are articulated clearly
• Experienced in good documentation practices and requirements for managing regulated records
• Demonstrated ability to contribute to a continuous learning and process improvement environment
• Some knowledge of how to create a successful product regulatory strategy
• Operates with a sense of urgency, agility, and flexibility

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
• Ongoing performance feedback and annual compensation review

For U.S. locations that require disclosure of compensation, the starting pay for this role is between $70,000 and $120,000 .

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.

U.S. based employees may be eligible for short-term and / or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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