• Position : Regulatory Affairs Associate (Labelling)
  • Department : Regulatory Affairs
  • Requisition :req6996
  • Job Type : Contract
  • Posting Date : 05/27/2020
  • Location : Brampton, Ontario

Taro is a multinational; science-based pharmaceutical company dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.         

Our Brampton location is presently looking for an Regulatory Affairs Associate (Labelling) - 12 month contract to join our Regulatory Affairs Department.

General Summary:

The Labelling Associate is responsible for the initiation, review and approval of artwork in compliance with Health Canada requirements, specifically the implementation of the Drug Facts Table for OTC products.

Principal Duties and Responsibilities :

  • Review internal labelling documentation for adherence to regulatory guidelines.
  • Create master text for labelling for new filings to Health Canada.
  • Initiate, review and approve artwork in compliance with Health Canada requirements
  • Prepare submissions in eCTD format which involves full understanding of the use of Adobe Acrobat to create bookmarks and links. 
  • Review and file post approval submissions to Health Canada for revised labelling.
  • Prepare written responses to deficiency letters from Health Canada in the stated time frame.
  • Review internal labelling documentation for adherence to regulatory guidelines.
  • Assist in the review and development of procedures, guidelines and maintenance system for labelling development, approval and control.
  • Ensure documentation is maintained, both hardcopy and electronically.
  • Other duties as required by the Manager.

Knowledge, Skills and Abilities

  • Minimum B. Sc. in a Chemistry, Pharmacy or Life Science discipline combined with at least two (2) to five (5) years of relevant experience within a Canadian Regulatory Affairs pharmaceutical environment.
  • Strong working knowledge of current regulatory guidelines for TPD.
  • Experience with eCTD submissions and knowledge of GMP and QA/QC procedures is preferred.
  • Knowledge of the use of eCTD Software for preparing and filing submissions preferred.
  • Strong organizational ability to maintain a complex and high volume of technical information up to date.
  • Proficiency with applicable computer software – Microsoft Office including Word, Excel and PowerPoint and Adobe Acrobat and Document Management Systems.
  • Excellent interpersonal, written and verbal communication skills. 
  • Ability to plan, coordinate and work effectively in a team-oriented environment. 
  • Fluency in French an asset.

If you are interested in this opportunity, please submit your resume to hr@taro.ca referencing Regulatory Affairs Associate (Labelling) - contract in the subject line. We thank all applicants, but only those selected for further consideration will be contacted. No phone calls please.

This position is open to applicants legally authorized to work in Canada.

Taro Pharmaceuticals embraces diversity in the workplace and is committed to achieving employment equity. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We ensure that our recruitment practices are supportive of this commitment and do not infringe on any characteristics protected by law.

In accordance with the Accessibility for Ontarians with Disabilities Act, 2005, and the Ontario Human Rights Code, Taro Pharmaceuticals will provide accommodation throughout the recruitment and selection process to applicants with disabilities. If selected to participate in the recruitment and selection process, please inform Human Resources of the nature of accommodation(s) that you may require in respect of any materials or processes used to ensure your equal participation.

NOTE: All employment is conditional upon the completing and obtaining of a satisfactory background check which may  include educational, employment, references and criminal records (for which a pardon has not been granted) checks.

AGENCY NOTICE: Please note that Taro Pharmaceuticals does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with an agency / recruiter, Taro Pharmaceuticals will not consider any referrals or agree to payment of referral or recruitment fees. In the event a recruiter or an agency submits a resume or candidate without a previously signed agreement, Taro Pharmaceuticals explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency. 

To learn more about Taro Pharmaceuticals Inc., please visit: www.taro.ca.

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