More Information
- Address 23 Lesmil Road, Toronto, ON, M3B 3P6
- Education Bachelor Degree
- Language Required English
- Disclosure Only selected candidates will be invited for interview
PharmEng Technology, one of the leading pharmaceutical consulting firms in the world with offices in USA, Canada and Asia, is hiring a full time, experienced regulatory affairs specialist.
This is a full time position of 40 hours per week and available immediately.
Responsibilities:
Provide guidance and support to business on regulatory policies and procedures;
Ensure internal compliance with regulatory requirements;
Review CMC dossiers prior to Regulatory Authority Submission
Project Manage the integration of all new products into Change Control Management(CCM) System and identify suitable CCM systems for the integration (example: PDM, EDMS, REGISTER, QUANTUM etc)
Develops regulatory strategies for rapid approval
Communicates with and influences multiple local and global functions to achieve regulatory objectives
Interprets regulations, guidelines and policies from countries in APAC region
Plan the reorganization of the operations of an establishment
Mentors junior staff
Qualifications:
• B.Sc. in life science or relevant scientific field (e.g. Chemical Engineering, pharmacology, chemistry)
At least five (5) year experience working in regulatory affairs
Must possess a thorough understanding of the regulations in APAC region such as ASEAN member countries
Highly innovative, creative problem solver and decision maker
Fully developed project management skills
Ability to continuous improvement techniques to gain efficiencies in submission preparation and product approval process
Strong interpersonal skills, with strong written and oral communication skills
Must act with integrity and demonstrate a strong and effective risk management perspective
Computer literate with excellent knowledge of Office Applications
Salary
$50.00/hr CAD
Location:
23 Lesmil Road, Toronto, ON, M3B 3P6
Position:
Permanent, Full-Time
Benefits:
You will also be enrolled in all Company benefit programs after the probationary period has been successfully completed.
Life Insurance
Accidental Death
Long Term Disability
Dental and Healthcare
RRSP Group Savings Program (After 12 months of Service)
How to apply:
By email: careers@pharmeng.com
Expires July 04 , 2020