Senior Principal Regulatory Affairs Specialist

Job description

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 worldfrom 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:**
Responsible for the overall product strategy, reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence and change management for consumer products (Rx/OTC, OTC Monograph, Nutritional, and Cosmetics).
**Responsibilities:**
+ Interpret Regulatory Authority policies, regulations and guidances and correctly apply them, as appropriate
+ Provide technical expertise internally and/or externally as subject matter expert
+ Participate in external industry forums (such as trade associations, committees and regulatory boards) as required and influence externally
+ Represent BNL in external committees and boards as required
+ Coach and mentor individuals on subject matter expertise
+ Provide guidance and direction regarding regulatory strategy to project teams
+ Participate in assigned due diligence activities for business development and acquisitions
+ Utilize multiple regulatory databases to ensure the stringent accuracy of information for creation of cosmetics, OTC Drug Facts and nutritional/natural health products in the US and/or Canada
+ Formulate, lead, and drive integrated regulatory strategies across CMC and clinical/non-clinical, labeling, adpromo domains
+ Lead all CMC regulatory activities for IND, NDA and ANDA submissions and OTC products and dietary supplements
+ Plan, author, review, and coordinate high-quality submission components (including complex variations such as PAS, group supplements, site transfers, and supplier changes) for IND, NDA, ANDA amendments/supplements
+ Review raw materials and formulations, provide advice to product development teams and give guidance on potential regulatory compliance issues
+ Point of contact with Health Authorities and ability to manage the relationship with Health Authorities
**Qualifications:**
+ Bachelor's degree or equivalent; Master's degree preferred
+ Minimum of 8 years in Regulatory Affairs with experience in the consumer product (Rx/OTC, OTC Monograph, Nutritional, and/or Cosmetics) regulated environment
+ Thorough understanding of regulatory processes and information systems.
+ Demonstrated ability in analytical reasoning and critical thinking skills
+ Ability to influence internal and external key stakeholders and KOL's
+ Ability to handle multiple tasks and meet deadlines
+ Strong capability to contribute in a team environment
+ Ability to support internal/external business stakeholders
+ Excellent organizational and communication skills; both oral and written
+ 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
+ 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
+ Capability to effectively work independently
+ Experience in practical understanding, interpretation, and application of US regulatory requirements for cosmetic products (MoCRA), including state-specific requirements and CPSC requirements preferred
+ Experiencewith innovative approaches and general regulatory requirements for Rx to OTC switch preferred
+ Ability to interpret Regulatory Authority policies, regulations and guidances and correctly apply them, as appropriate
+ 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
+ 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
+ Ability to influence external regulatory stakeholders and shape the external regulatory environment.
+ Advanced Project Management / leadership experience with the ability to influence team members that are not within their reporting structure
+ The ability to work effectively with key national opinion leaders, and advisory boards
+ Working knowledge of FDA regulations / Code of Federal Regulations (CFR)
**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(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 $120,000 and $180,000 per year.

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 readBausch + 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.

Required Skill Profession

Other General