Director, Regulatory Affairs

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. 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. 

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

• Formulate, lead and drive CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance. 
• Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle to interdisciplinary project teams and to appropriate management level in Regulatory Affairs, R&D, TechOps and Supply Chain as appropriate in a timely manner. 
• Lead and drive all CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Make quality regulatory decisions, balancing risks and benefits. 
• Identify, as early as possible, the required documentation and any content, quality and/or timeline issues. Negotiate the delivery of approved technical source documents in accordance with project timeline.
• 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.
• Participate in assigned due diligence business activities and lead the CMC review and recommendations.
• Review and provide input on proposed health authority guidance documents on CMC issues.
• Competent in authoring and reviewing CMC sections for IND, NDA, ANDA and/or BLA new applications.
• Competent in authoring and reviewing complex submissions (i.e. PAS, group supplements, multiple changes, site transfer, new DS supplier).
• Manage multiple products that are marketed internationally.

Minimum Requirements

Bachelor’s degree preferred or equivalent.

Minimum of 10 years in Regulatory Affairs or relevant experience in a regulated environment.

Skill Requirements

• Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling
regulatory activities.
• Strong business acumen and ability to see the business drivers outside of Regulatory Affairs. • Ability to take innovative ideas to promote a successful regulatory submission and increase the probability of regulatory approval.
• Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are
adequately supported by data.
• Strong interpersonal skills with the ability to influence others in a positive and effective manner.
• Demonstrated ability to contribute to a continuous learning and process improvement environment.
• Excellent communication skills; both oral and written.
• Capability to react quickly to changes in the regulatory environment and make strategic recommendations to minimize risk to the business.
• Capacity to react quickly and decisively in unexpected situations.
• Strong capability to support and provide strategic direction for the team.
• Advanced people management / leadership experience with the ability to influence team members that are not within their reporting structure.
• The ability to work with key national opinion leaders, and advisory boards (represents the company on advocacy groups).

• Ability to prioritize assignment of projects, coordinate resources simultaneously and work with tight deadlines.

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.

This position may be available in the following location: Remote

As required by New York State's pay transparency bill, Bausch + Lomb provides a good faith minimum and maximum salary range of compensation for roles that can or will be performed, in New York State.  Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location.  For New York State, the range of starting salary for this role is $150k - $200k..

As required by Colorado’s Salary Transparency Law, Bausch + Lomb provides a good faith minimum and maximum salary range of compensation for roles that can or will be performed, in Colorado.  Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location.  For Colorado, the range of starting annual base pay for this role is $150k - $200k..”

Our Benefit Programs:  https://www.bausch.com/careers/benefits/

As required by New York City’s salary transparency provisions of the New York City Human Rights Law, Bausch + Lomb provides a good faith minimum and maximum salary range of compensation for roles that can or will be performed, in New York City.  Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location.  For New York City, the range of starting annual base pay for this role is $150k - $200k..

As required by California's Salary Transparency Law, Bausch + Lomb provides a good faith minimum and maximum salary range of compensation for roles that can or will be performed, in California.  Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location.  For California, the range of starting annual base pay for this role is $150k - $200k..

As required by Washington's Salary Transparency Law, Bausch + Lomb provides a good faith minimum and maximum salary range of compensation for roles that can or will be performed, in Washington.  Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location.  For Washington, the range of starting annual base pay for this role is $150k - $200k..

Our Benefit Programs:  https://www.bausch.com/careers/benefits/

As required by Hawaii's pay transparency bill, Bausch + Lomb provides a good faith minimum and maximum salary range of compensation for roles that can or will be performed, in Hawaii.  Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location.  For Hawaii, the range of starting annual base pay for this role is $150k - $200k..

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.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

To learn more please read Bausch+Lomb's Job Offer Fraud Statement.

Our Benefit Programs: https://www.bausch.com/careers/benefits/

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

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