Regulatory Affairs Specialist

Bausch+Lomb, a division of Bausch Health Companies Inc (BCH), is solely 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.The company is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products.

Our highest priority is the well-being of the people we serve. By listening to our customers and patients, by constantly honing our innovation edge, by executing with integrity and excellence, we strive to earn the trust of our partners and stakeholders.

Over the last 150 years, Bausch + Lomb has become a global hallmark for innovation and quality. Our talented and motivated colleagues work relentlessly to invent new materials, engineer new technologies, and ultimately bring new innovations to help people see better to live better.

**Overall Function**:
Primary contact for Regulatory strategy and submissions expert for drugs and Natural Health Products (NHP) in Canada. Prepare and compile drug submissions in the eCTD format to Health Canada to achieve marketing authorization and maintain currently marketed drugs and NHPs in compliance.

Provide Regulatory strategy assessment for Canada to internal stakeholders and implement according to agreed plan for drugs and NHPs.

Plan, manage and coordinate the compilation, filing and approval of high-quality regulatory submissions made to Health Canada according to agreed plan.

Maintain and ensure product compliance through relevant regulatory registrations and interactions/negotiations with internal stakeholders and Health Canada.

**Duties and Responsibilities**:
Prepare submissions to Health Canada for different dosage forms (NDS, ANDS, S/ANDS, CTA, NC, Annual Report, and/or Cross-Licenses) for drug products (prescription, OTC) and NHPs, as applicable

Assist in the preparation and/or review of responses to Health Canada letters (e.g., Notice of Non-Compliance, Notice of Deficiency, and Clarifaxes)

Assist in the review of Product Monographs, Package Inserts and Label text

Coordinate French translations of Product Monographs and Package Inserts

Assist in negotiations with Health Canada to ensure prompt regulatory approvals

Liaise with groups internally and externally to collect necessary documents and information

Assist in the review of Change Controls and the determination of filing/notification requirements

Provide regulatory support to internal/external customers

Maintain current awareness of regulatory guidelines (Health Canada, ICH, EMEA, FDA, etc.)

Other duties as required by the Director or Supervisor

**Desired Skills & Experience**:
Qualifications/Requirements - Competencies

University Degree, B.Sc. or higher in Health Sciences

Minimum 3 years of relevant experience in Canadian Pharmaceutical Regulatory Affairs, with recent (1-2 years) experience/expertise in managing Natural Health Products

Strong working knowledge of Canadian regulatory guidelines, drug development, manufacturing and commercialization of pharmaceutical products (drug products and Natural Health Products)

Excellent organizational and communication skills (oral and written)

Excellent project management skills

Ability to prioritize projects, coordinate multiple projects simultaneously and work with strict deadlines

Computer Literacy - Microsoft Office including Word, Excel, and Outlook; Adobe Acrobat

Attributes

Detail Oriented

Ability to work in a team and individually with minimum supervision

Ability to share expertise and know how within the team

Proactive, highly motivated and results oriented

Flexibility and openness to acquire/develop new expertise

High Energy / Results Oriented

Excellent analytical and writing skills

Bilingual (preferred)

The masculine is used in this publication without prejudice for the sake of conciseness.

Bausch & Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.

We are an equal opportunity employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply. Accommodations for job applicants with disabilities are available on request.