- Filing
- Administrative experience
- Communication skills
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:
Support the preparation of administrative documents for submissions to Health Canada for different dosage forms for drug products (prescription, OTC) and NHPs, as applicable
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)
Review of labeling for some products
Maintain Current Product List and up-to-date list of current PMs
Support compliance by providing requested information to Pharmacovigilance
Liaise with groups internally and externally to collect necessary documents and Information
Prepare Label Change Request forms for artwork updates
Assist in the review of Change Controls and the determination of filing/notification requirements
Other duties as required by the Director or Supervisor
QUALIFICATIONS:
Bachelor of science degree (B.Sc.),
Postgraduate studies (diploma) in drug development/regulatory affairs preferred
Relevant administrative experience (1 year plus), preferably in the pharmaceutical industry.
Knowledge and understanding of regulatory submission requirements, eCTD format, and other related material.
Able to prepare forms and cover letters for health authority submissions; to upload final submission documents into document management systems according to eCTD guidelines.
Excellent organizational and verbal/written communication skills are necessary.
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.
