Senior Regulatory Affairs Associate

Mississauga, ON

Mint Pharmaceuticals is a Canadian owned and operated company using innovative simplicity to deliver high quality, low cost generic pharmaceuticals to the Canadian market. Founded in 2007, we pride ourselves in delivering high quality and affordable generic pharmaceuticals and healthcare solutions to the Canadian market. Through product differentiation, best-in-class supply and excellent service, we strive to help communities across Canada live longer, healthier lives.
We are currently seeking a self-motivated individual to join the Regulatory Affairs team. The successful candidate will be a critical team member responsible for filing submissions and obtaining approval for new pharmaceutical products in Canada. This exciting position offers a great opportunity for professional development with a rapidly growing Canadian company.
Mint offers an attractive compensation package that encompasses a competitive salary, benefits and the opportunity to have a rewarding employment experience. We are an equal opportunity employer.
Primary Functions:
The Senior Regulatory Affairs Associate will be primarily responsible for managing the compilation, filing and approval of new regulatory submissions for prescription pharmaceuticals with Health Canada in a timely manner.

  • Compile, write and publish electronic regulatory submissions (ANDS, Cross Licence Applications) to Health Canada in a timely manner with minimal guidance.

  • Prepare responses to deficiency letters (Notices of Non-Compliance, Notices of Deficiency, Screening Deficiency Notices and Clarifaxes) in a timely manner with minimal guidance.

  • Perform thorough reviews of submission documentation for compliance with Health Canada requirements. Identify weaknesses for submission and provide guidance to key stakeholders to ensure submission documentation complies with Canadian requirements.

  • Prepare product labelling (including Product Monographs) and coordinate French translations.

  • Liaise with Health Canada, as necessary, to negotiate the timely approval of filed submissions.

  • Communicate with internal and external stakeholders to obtain documents required to support regulatory submissions.

  • Review documentation and provide regulatory input on development projects to ensure compliance with Canadian requirements.

  • Assist the RA Manager in providing training and guidance to less experienced staff members.

  • Assist the RA Manager in reviewing regulatory submissions prepared by junior staff members.

  • Remain up to date on applicable regulatory guidelines (Health Canada, ICH, etc.).

  • Develop departmental working guidelines to document standard processes in the department.

  • Any other duties as assigned by the Regulatory Affairs Manager.

Skills & Qualifications:

  • Bachelor of Science (or higher) in Biological Sciences, Pharmacology, Toxicology, Chemistry or related Health Sciences

  • Must have a minimum of four (4) years of experience filing regulatory submissions

  • Must have strong technical knowledge of CMC requirements and ability to critically analyze scientific data

  • Strong interpersonal skills and ability to foster strong working relationships with key stakeholders (internally and externally) and government representatives from Health Canada

  • Strong working knowledge of Canadian Food and Drugs Act and Food and Drug Regulations , GMPs, ICH Guidelines and Health Canada Policies and Guidelines

  • Knowledge of the Medical Devices Regulations is an asset

  • Ability to prioritize workload to ensure all deadlines are met

  • Experience with publishing eCTD submissions is an asset

  • Ability to work independently with minimal supervision

  • Excellent organization, written and oral communication skills

  • Ability to effectively manage multiple projects in a fast-pace, results oriented environment

  • Strong commitment to quality, accuracy and detail

  • Ability to work well under pressure in a team based environment

  • Strong problem solving/analytical ability and issue resolution skills

  • Proficient in computer applications (Microsoft Office, Word, Excel, PowerPoint, etc.)

Mint Pharmaceuticals: 1093 Meyerside Drive, Suite 1, Mississauga, Ontario
Compensation & Benefits: CAD$67,000-$75,000.
Comprehensive benefits package including health, dental, life disability, eye/vision benefits.
Eligible for salary increases and/or bonuses in accordance with company policies.
Start Date: Immediately

Thank you to all applicants. Only those selected will be contacted.

Reference ID: 0e7fa923aa4d

Date Posted: 10/17/2016

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