Regulatory Affairs Specialist
- Listed: February 8, 2018 5:30 pm
- Expires: This ad has expired
Description
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 in regulatory affairs.
This is a full time position of 40 hours per week and available immediately.
Responsibilities:
- Conduct research to determine efficiency and effectiveness of managerial programs
- Conduct assessments and propose improvements to procedures
- Provide guidance and support to business on regulatory policies and procedures;
- Interprets regulations, guidelines and policies from countries in APAC region
- Ensure internal compliance with regulatory requirements;
- Review CMC dossiers prior to Regulatory Authority Submission
- Project Managent 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
- Plan the reorganization of the operations of an establishment
- Mentors junior staff
Qualifications:
- A bachelor’s degree or college diploma in business administration, commerce, pharmaceutical or a related discipline.
- 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
Location:
Canada, ON
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)
Apply to Tracy.g@pharmeg.com
Listing ID: 5925aca97f8843e9