Download Senior Regulatory Affairs Associate Markham, Ontario

Cytochroma Inc.
330 Cochrane Drive, Markham, ON L3R 8E4 Canada
TEL (905) 479-5306 FAX (905) 479-1287
Senior Regulatory Affairs Associate
Markham, Ontario
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
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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 [email protected].
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.