• Regulatory Affairs Associate Jobs in Canada - 25366646

  • Baxter India Pvt Ltd
  • Canada
  • Save Job
  • 1 - 4 Years
  • Posted : above 1 month

Job Description:

Baxter International

Around the world, our employees are united by our mission to save and sustain lives Together, we create a culture that encourages colleagues to pursue rewarding careers -- where everyone has the opportunity to do meaningful work as a part of a team they respect, in an environment that values each persons contributions Were happy youre interested in continuing your career journey with Baxter

The RA Associate is responsible for planning and execution of regulatory submissions to meet Canadian and Global business requirements Ensures product life cycle compliance as per the Health Canada Food and Drugs Act and Regulations

Essential Duties

Provide input to Global and local RA strategies Assess potential risks and provide input for product development plans Review regulatory project plans/protocols and reports to meet Canadian regulatory requirements in collaboration with Global and local partners

Prepare high quality submissions including NDS, SNDS, Medical Device Licence Applications, CTAs, etc according to current Health Canada requirements Collaborate with global and local teams to provide accurate responses to stakeholders within set deadlines

Assess proposed product, process and manufacturing site changes and execute necessary actions for implementation

Support Third Party efforts

Support continuous improvement initiatives by actively participating on local and global cross-functional project teams ensuring milestones are met May be required to lead small projects (eg RFPs, JDE SOPs) Establish and/or improve local processes by reviewing, providing input and/or drafting departmental/cross-functional SOPs and Global procedures

In collaboration with Marketing, Medical Affairs and other business partners review and approve labeling and promotional material for regulatory compliance Compile materials required for Annual Drug / Device Notifications, Yearly Biologic Product Reviews and Site Licence Renewals

Participate in driving compliance with the quality system within regulatory affairs in assigned areas of responsibility Organize and maintain regulatory documentation in a format consistent with current RA practices and Baxter processes Administrative duties as assigned

Maintain awareness of current regulatory environment and guidelines that impact the Industry, the RA Department and Baxter Analyze, provide input into and compile comments for proposed regulations, guidance documents and policies Maintain close communication with both internal and external business partners and build solid advocate network to drive outcomes

Education/Experience

Education Level

Required

University degree in Science and / or relevant work experience

Preferred

University Degree in Science
Post Graduate Certificate in Regulatory Affairs

Major Subjects / Specialties

Required

Science Degree (eg Pharmacy, Chemistry, Biology, Pharmacology)

Type of Experience

Required

Knowledge of Canadian Food and Drugs Act and Regulations and Medical Device Regulations as well as Health Canada policies and guidelines
Ability to interpret and apply Health Canada regulations, policies and guidelines

Preferred

Working knowledge of Canadian Food and Drugs Act and Regulations and Medical Device Regulations as well as Health Canada policies and guidelines
Drugs/biologics/devices and manufacturing experience, pharmaceutical or health care background
Strong technical knowledge of pharmaceutical manufacturing, quality assurance, GMP, ISO, ICH Guidelines

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare
Functional Area : HR / Administration / IR
Role : Chartered Accountant/CPA
Salary : As per Industry Standards
Deadline : 09th Jun 2020

Key Skills:

Would you like to try out these free online tutorials?

People who search this job also searched for the following Keywords

Salary trends based on over 1 crore profiles

View Salaries

All rights reserved © 2018 Wisdom IT Services India Pvt. Ltd DMCA.com Protection Status