Regulatory Affairs Specialist

Your Role & Responsibilities

Job Description:

• Supporting the regional Pharma division Sales Team on topics including regulatory, legal, compliance, quality and product safety.
• Completion of technical and regulatory information requests from customers within the pharmaceutical industry (questionnaires, supply chain agreements, QAA’s & TA’s) in and English.
• Contribute as part of team to maintenance of EMEA document management system to keep product and supplier information up to date.
• Request product and supplier information directly from manufacturers and indirectly via other internal channels.
• Process Change Control Notifications.
• Maintain customer specific information such as completed questionnaires, supply chain agreements, QAA’s, TA’s in the designated database.
• Creation and ongoing update of product regulatory information in standardized information packs.
• Support of customer, regulatory and 3rd party audits.
• Reporting and documenting customer requests via KPIs.
  
  

Your Profile

Education and Experience:

• 2 years previous experience working with regulatory documentation.
• Knowledge of ISO9001, food safety or GxP systems.
• University degree in life sciences
• Knowledge of pharmaceutical industry requirements and regulations on APIs, Excipients and starting materials.
• Previous experience with the FDA (or another national competent authority) and their requirements.
• Team player, strong communication and interpersonal skills, with ability to work across all levels, and functions
  
  

Our Offer

• We aim to create an environment where the best people want to work, where they can turn their passion into their job and realize their full potential.
• Individual development, on-the-job training, and development programs designed to help our employees grow in their careers.
• Competitive pay and incentives.
• Health and dental paid by company (with exception of LTD)
• DC pension plan matched 100% by employer up to 6%
• EFAP
• Starting 3 Weeks Vacation
• Flexible Work Hours
• Gym/Wellness subsidy
• Tuition Reimbursement
  
  

Interested?

We look forward receiving your application.

Brenntag Canada Inc. is committed to building a workforce that reflects the communities we serve and to promote a diverse, inclusive, accessible, merit-based, respectful and equitable workplace. Brenntag Canada Inc. provides equal employment opportunities to qualified applicants and employees without regard to race, ancestry, place of origin, colour, ethnic origin, citizenship, creed, sex, sexual orientation, record of offences, age, marital status, family status, religion, gender identity, protected veteran status, disability or any other status protected by applicable Canadian, provincial or local law.

We offer employment accommodation across the recruitment process and all aspects of employment consistent with the requirements of applicable law. Let us know if you require a disability-related accommodation.

Collection of Information

Your personal information is being collected and will be used to determine your qualifications for employment with Brenntag Canada Inc. This collection of personal information is necessary to the proper administration of the application process. Please do not provide more personal information than what is asked of you. For example, do not include your social insurance number, photograph, or banking information, etc. with your application. We strongly encourage you not to provide us with information beyond that which is requested in the job posting. If you have any questions about the collection, use, disclosure, or retention of your personal information, please contact us.

Brenntag Canada Inc. is an inclusive employer.

Accommodation is available in accordance with the applicable law.

Brenntag TA Team