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Regulatory Affairs Specialist

3 months ago

Laval, Quebec, Canada Bausch & Lomb Full time

Bausch & Lomb is a prominent player in the pharmaceutical industry, dedicated to delivering superior products that enhance the health and wellness of individuals. Our organization is involved in the production and distribution of a diverse array of pharmaceutical and health-related products across various markets.

At Bausch & Lomb, we prioritize the growth of our workforce and are committed to fostering an environment that encourages innovation and performance to address contemporary challenges.

  • Oversee, organize, and facilitate the preparation, assembly, submission, and approval of comprehensive regulatory submissions to Health Canada in eCTD format, aimed at securing market authorization for both new and existing pharmaceutical offerings.
  • Draft and evaluate responses to communications from Health Canada (such as non-compliance and insufficiency notices) promptly; assist in negotiations to expedite the regulatory approval process for pending submissions.
  • Assess change controls, prepare and compile L3 submissions to uphold compliance and manage the product lifecycle for marketed products; update CPID and relevant regulatory documentation.
  • Thoroughly analyze data and documentation to pinpoint deficiencies in regulatory requirements.
  • Ensure and maintain regulatory compliance for products. Engage, communicate, and negotiate with both internal and external stakeholders, including Health Canada.
  • Remain informed about all regulatory guidelines (Health Canada, ICH, etc.).
  • Provide support to the Senior Manager RA-CMC as required.

QUALIFICATIONS:

  • University degree, B.Sc. or higher (master's or doctorate) in health sciences. A post-graduate diploma in Drug Development and/or RAC certification is advantageous. Relevant experience in quality assurance/compliance is also beneficial.
  • A minimum of 4 years of pertinent CMC experience in pharmaceutical regulatory affairs within Canada, with a focus on pharmaceutical product management and lifecycle from a CMC viewpoint. Experience with biologics is also a plus.
  • Robust practical understanding of Canadian regulatory guidelines, drug development processes, pharmaceutical manufacturing, and marketing strategies.
  • Exceptional organizational and communication abilities (both verbal and written).
  • Bilingual proficiency (English and French).
  • Capability to prioritize tasks, manage multiple projects concurrently, and operate under tight deadlines.
  • Entrepreneurial mindset, customer-centric approach, business insight, adaptability, teamwork, and respect for colleagues.
  • Proficient in computer applications – Microsoft (Word, Excel, Outlook); Adobe Acrobat, Veeva, Docubridge, Trackwise.

The masculine gender is used solely for the purpose of readability and is not intended to be discriminatory.
Bausch & Lomb adheres to the principle of equal employment opportunity and complies with applicable laws regarding equal access to employment in all its operations.