Employment Opportunities:

Senior Regulatory Affairs Associate (Markham location)

Job Purpose:

• To provide regulatory support to Cytochroma’s drug development activities; review clinical documentation and prepare regulatory submissions to support premarketing development, clinical studies and marketing applications.

Duties and Responsibilities:

• Prepare regulatory submissions to support Cytochroma clinical development in Canada and US. Knowledge of other regulatory environments a plus.
• Maintain regulatory submissions in compliance with requirements, including protocol and information amendments, annual reports etc as appropriate.
• Act as regulatory lead for eg, IB or agency meeting package development
• Participate as regulatory representative in clinical study teams; support Cytochroma clinical studies by reviewing documentation (protocols, ICF templates); participate in activities such as clinical label generation/approval, site approval for drug release, ICF review as required.
• Maintain regulatory files and listings.
• Maintain regulatory expertise by reviewing agency publications, attending courses etc and communicate relevant information to Cytochroma personnel.
• Prepare documents as “submission-ready” for electronic filing per departmental requirements; knowledge of eCTD a bonus

Qualifications:

• Minimum BSc. in related subject; post-graduate certification in Regulatory Affairs a plus
• Minimum 3 years related experience in pharmaceutical regulatory affairs
• Ability to work independently under general supervision, adapt to changing priorities and manage multiple tasks
• Good organizational and planning skills
• Strong written, verbal and interpersonal skills
• Computer skills in Word and Adobe; knowledge of electronic regulatory publishing process a plus.
• Excellent oral/written communication and interpersonal skills.
• A commitment to excellence and teamwork.
• Attentive to details, good observation skills.
• Good organizational and time management skills.

To apply for this opportunity, please submit your resume in confidence to hr@cytochroma.com. Please ensure that you quote the job title in the subject line of your email.

We thank all applicants for their interest; however, only candidates under consideration will be contacted. No phone calls please.