Overview

ACIC Regulatory Affairs Associate/Specialist Full Time in Brantford, ON

ACIC

Branch Brantford ON CA

Position:
Regulatory Affairs Associate/Specialist
Location:
Brantford, ON

Canadian/US Pharmaceutical Regulatory Affairs:. 3-5 years experience in Regulatory Affairs within the Canadian and/or US pharmaceutical industry….

ACIC is expanding and looking for highly qualified and experienced professionals to join our Scientific Affairs team in the areas of regulatory affairs, quality and technical services.

We are currently actively recruiting for experienced specialists in Regulatory Affairs.

As a member of our team, you will be responsible for compiling, submitting and maintaining drug product registrations for Canada, the US, and International markets.

Key Responsibilities:

  • Prepare and/or review submissions to Health Canada and US FDA for a variety of dosage forms in eCTD format (NDS, ANDS, NDA, ANDA)
  • Prepare and/or review responses to deficiency letters (NONs, NODs, Clarifaxes, major and minor Amendments)
  • Review Change Controls and provide input into regulatory filing assessment. Prepare and/or review documentation for Post Approval submissions.
  • Liaise with regulatory agency to ensure prompt regulatory approvals. Raise visibility of issues impacting the overall regulatory strategy.
  • Provide regulatory support to internal/external customers through timely review of regulatory documentation.
  • Maintain current awareness of regulatory guidelines (Health Canada, FDA, EU, ICH).

Qualification Requirements:

  • University degree in a scientific discipline
  • 3-5 years experience in Regulatory Affairs within the Canadian and/or US pharmaceutical industry
  • Completion of a postgraduate Regulatory Affairs Certificate is an asset
  • Strong working knowledge of current Health Canada, FDA, as well as ICH regulatory guidelines.
  • Knowledge and application of registration procedures in Europe (CP, DCP, MRP, Variations) and other international markets would be an asset
  • eCTD submission experience is preferred
  • Excellent communication and interpersonal skills (oral and written)
  • Strong organizational ability and management of multiple priorities combined with a proven ability to meet strict and established timelines

Benefits

  • RRSP Matching
  • Health Benefits
  • Disability & Life Insurance Package

Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. Individuals selected for interviews will be forwarded application form to be completed and forwarded to HR Department prior to interview.

Job Type: Full-time

Required experience:

  • Canadian/US Pharmaceutical Regulatory Affairs: 3 years

or proceed with Standard Application Form.

Employment Type: Full Time
Location: Brantford, ON, CA
Posted on: 2016-09-22
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