Employment Opportunities:

Sr. Regulatory Affairs Associate – Markham, Ontario

The Sr. Regulatory Affairs Associate will report to the Director, Regulatory Affairs and will provide regulatory support to Cytochroma’s drug development activities; review clinical documentation and prepare regulatory submissions to support clinical trials and marketing applications.

Key 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.
• Support Cytochroma clinical studies by reviewing documentation (protocols, ICF templates) for regulatory compliance; participate in activities such as clinical label generation/approval, site approval for drug release, ICF review as required.
• Maintain regulatory files and listings; maintain departmental SOPs.
• Maintain regulatory expertise by reviewing agency publications, attending courses etc and communicate relevant information to Cytochroma personnel.
• Work with Regulatory Operations to ensure effective process for electronic submissions; acts as back-up support for publishing when necessary.
• Provides resource as “superuser” for Cytochroma’s electronic document management system; supports other departments where necessary.

Skills & Qualifications:

• Minimum BSc. in related subject; post-graduate certification in Regulatory Affairs a plus
• 3 years 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.