What are the responsibilities and job description for the Manager, Regulatory Affairs (Ophthalmic Laser) position at Lensa?
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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
Global – Responsible for the overall product strategy, global reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence and change management.
Regional and/or Local - Responsible for pharmaceutical, consumer and medical device regulations in Regional and Local markets. The team partners closely with commercial leaders to define strategy and execute registrations, provides regulatory intelligence and ensures regulatory compliance.
Responsibilities
Bachelor degree preferred (or equivalent education and experience).
Minimum of 6 years in Regulatory Affairs or relevant experience in a regulated environment.
Excellent communication skills (oral and written); bilingual (Country specific).
Computer Literacy – Microsoft Package including Word, Excel, and Outlook; Adobe Acrobat
This position may be available in the following location(s): [[location_obj]]
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.
For U.S. locations that require disclosure of compensation, the starting pay for this role is between $100,000.00 and $135,000.00. 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. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
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 (https://performancemanager.successfactors.eu/doc/custom/BauschLomb/Bausch_job_posting_statement.docx) .
Our Benefit Programs: Employee Benefits: Bausch Lomb (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.
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
Global – Responsible for the overall product strategy, global reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence and change management.
Regional and/or Local - Responsible for pharmaceutical, consumer and medical device regulations in Regional and Local markets. The team partners closely with commercial leaders to define strategy and execute registrations, provides regulatory intelligence and ensures regulatory compliance.
Responsibilities
- Develop and mentor team of individual contributors/subject matter experts
- Responsible for global portfolio management and strategy; provide guidance and direction regarding regulatory strategy to project teams
- Take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval
- Actively lead and/or participate in project team activities
- Critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported by data
- Prioritize assignment of projects, coordinate resources simultaneously and work with tight deadlines
- Communicate with regulatory authorities on the company's behalf
- Act as point of contact with Health Authorities and possess the ability to manage the relationship with Health Authorities as assigned
- Strong working knowledge of regulatory guidelines, development, manufacturing, and commercialization of products
- Strong organizational skills and excellent in managing multiple priorities
- Entrepreneurship and focus on customer needs; good business acumen and sense of urgency; agility and flexibility
- Knowledge of current and emerging issues and trends
- Strong capability to contribute, lead a team, teach and mentor/develop team
- Thorough understanding of regulatory processes and information systems
- Demonstrated ability in analytical reasoning and critical thinking skills
- Can provide technical expertise internally and/or externally as subject matter expert
- Provide coaching and mentoring to individuals on subject matter expertise
- Strong interpersonal skills with the ability to influence others in a positive and effective manner; ability to support internal and external key stakeholders and KOL
- Ability to handle multiple tasks and meet deadlines
- Strong capability to contribute in a team environment
- Demonstrated ability to contribute to a continuous learning and process improvement environment
- Capacity to react quickly and decisively in unexpected situations
- Ability to author pre-market and post market registration documents
- Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
- Focused ability to influence operational excellence and performance metrics
- Risk adverse where needed with the ability to identify potential solutions to complex problems
- Ability to work independently
Bachelor degree preferred (or equivalent education and experience).
Minimum of 6 years in Regulatory Affairs or relevant experience in a regulated environment.
Excellent communication skills (oral and written); bilingual (Country specific).
Computer Literacy – Microsoft Package including Word, Excel, and Outlook; Adobe Acrobat
This position may be available in the following location(s): [[location_obj]]
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.
For U.S. locations that require disclosure of compensation, the starting pay for this role is between $100,000.00 and $135,000.00. 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. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
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 (https://performancemanager.successfactors.eu/doc/custom/BauschLomb/Bausch_job_posting_statement.docx) .
Our Benefit Programs: Employee Benefits: Bausch Lomb (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.
Salary : $100,000 - $135,000
