SR. REGULATORY AFFAIRS ASSOCIATE
Mississauga, ON, Canada
Req ID 51277BR
Business Title
Sr. Regulatory Affairs Associate
Business
Latin America/Canada
Sub-Business
Multi-Business Support
Country
Canada
State/Province
Ontario
Location of Position
Mississauga, Ontario, CAN
Job Description
The Senior Regulatory Associate is responsible for development of RA strategies and execution of regulatory submissions to Health Canada. The incumbent will ensure compliance of post-approval activities as per the Health Canada Food and Drugs Act and Regulations.
Develop and maintain relationships with key stakeholders.
Prepare submissions of increasing complexity, including NDS, SNDS, Medical Device Applications, CTAs, etc. according to current Health Canada requirements. Collaborate with key stakeholders to provide accurate and timely responses to Health Canada. Identify priorities and key issues in complex situations and achieve resolution with minimal assistance.
Participate in driving compliance with the quality system within Regulatory Affairs. Organize and maintain regulatory documents in a format consistent with current RA practices and Baxter processes.
Assess proposed product, process and manufacturing site changes according to Health Canada regulations and initiate necessary actions to facilitate implementation. Support third party efforts.
Compile materials required for Annual Drug / Device Notifications, Yearly Biologic Product Reviews and Site Licence Renewals.
In collaboration with marketing, develop, review and/or approve labeling. Provide guidance to Marketing, Medical Affairs and other business partners on initiation or modification of labeling and promotional material ensuring regulatory compliance.
Assist in coaching less experienced associates.
Lead and provide guidance in the development and implementation of global and local regulatory strategies. Negotiate with regulators on specific projects relating to data requirements to ensure success.
Evaluate and identify risks, and provide contingency planning to ensure effective issue resolution.
Develop and/or review regulatory project plans/protocols and reports to meet Canadian regulatory requirements.
Lead, identify and drive continuous improvement initiatives by actively participating on local and global cross-functional project teams ensuring milestones are met. Establish and/or improve local processes by reviewing, providing input and/or drafting complex departmental/cross-functional SOPs and Global procedures.
Maintain awareness of current regulatory environment and guidelines that impact the Industry, the RA Department and Baxter. Analyze, interpret, assess impact, provide input into and compile comments for proposed regulations, guidance documents and policies. Maintain close communication with both internal and external business partners and foster positive relationships.
Administrative duties as assigned.
Job Requirements
Required:
•University degree in Science
•Sciences (e.g. Pharmacy, Chemistry, Biology, Pharmacology)
•Drug, biologic, device regulatory experience,
•Health Canada exposure
•2 - 3 years Canadian Regulatory Experience
•Good written and verbal communication skills
•Ability to work in a fast-paced dynamic environment
•Excellent time management skills and a sense of urgency
•Strong organization skills and ability to prioritize work load
•Accuracy and attention to details
•Excellent interpersonal and collaboration skills
•Ability to work independently and self-motivated to achieve results
•Proficient computer skills including MS Office Applications Preferred:
•University degree in Science, MSc.
•Post-graduate Certificate in Regulatory Affairs
•Project Management
•Strong technical knowledge of pharmaceutical manufacturing, quality assurance, GMP, ISO, ICH Guidelines
•Regulatory Project Management
•4 - 6 years Canadian Regulatory Experience
•Strong Project Management skills
•Strong negotiation skills
•Ability to lead, coach and motivate others
