Coordinator, Regulatory Affairs (6 Months)

Bausch + Lomb Corporation, (NYSE/TSX: BLCO), 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. Our mission is simple yet powerful: Helping you see better to live better.

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 167 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.

Summary Of The Position

The Regulatory Affairs Coordinator (6 months contract position) is responsible to support Canadian Regulatory Affairs activities related to Health Authority drug submissions, administrative maintenance of regulatory processes and other duties as required by the Director or Supervisor. With the guidance of the Global Regulatory Affairs Director or Canadian Regulatory Affairs lead, the incumbent supports and a wide variety of administrative and program support activities.

Key Responsibilities

• Assist in the review of Change Controls and the determination of filing/notification requirements
• Support compliance by providing requested information to Pharmacovigilance
• Circulation of Health Canada Correspondence to the team
• Assist in the preparation and/or review of responses to Health Canada letters (e.g., Notice of Non-Compliance, Notice of Deficiency, and Clarifaxes)
• Liaise with groups internally and externally to collect necessary documents and Information
• Other duties as required by the Director or Supervisor
• Review of labeling for some products
• Prepare Label Change Request forms for artwork updates
• Support the preparation of administrative documents for submissions to Health Canada for different dosage forms for drug products (prescription, OTC) and NHPs, as applicable
• Maintain Current Product List and up-to-date list of current PMs

Qualifications

• Bachelor of science degree (B.Sc.),
• Relevant administrative experience (1 year plus), preferably in the pharmaceutical industry.
• Knowledge and understanding of regulatory submission requirements, eCTD format, and other related material.
• Postgraduate studies (diploma) in drug development/regulatory affairs preferred
• Excellent organizational and verbal/written communication skills are necessary.
• Able to prepare forms and cover letters for health authority submissions; to upload final submission documents into document management systems according to eCTD guidelines.

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.