Regulatory Affairs Project Manager

Location: Mississauga, ON
Date Posted: 04-30-2018
Our client, a Canadian leader within the pharmaceutical space is looking for a Regulatory Affairs (RA) Project Manager that will be responsible for providing regulatory input and direction to Canadian Cross Functional Team and Global regulatory teams in order to deliver regulatory strategies, optimal Health Canada approvals, maintain compliance and maximize a product's potential and lifecycle in the Canadian marketplace. This opportunity is located in Mississauga.  
 
Responsibilities:

• Lead the development and implementation of regulatory strategic plans including Regulatory Strategy Documents
• Preparation, submission and negotiation of approvals of NDSs, SNDSs and NCs
• Maintenance of regulatory compliance of approved products
• Planning and conducting Health Canada meetings
• Preparation of Key External Experts for Health Canada meetings, participate in Health Canada advisory boards and write export opinions
• Development and finalization of Health Professional and Public Communications
• Review and approval of promotional materials
• Compile responses to ATI requests
• Provide strategic and decisive regulatory/business expertise across the organization as required
• Influence the global development of products, representing Canadian regulatory environment and market, to mitigate regulatory risks in the development plans
• Lead or participate in cross-functional and external initiatives
• Ensure regulatory submissions and documents are compliant with requirements and standards (e.g., Electronic submission processes)
• Provide comments on emerging Canadian regulations/policies/guidelines/initiatives/surveys
• Provide guidance and support to junior staff members (associates, students and assistants)

 
Requirements:

• B.Sc. or equivalent in a related (health science) discipline; advanced degree (M.Sc. or Ph.D.) considered an asset
• Strong knowledge of the Canadian regulatory environment and Health Canada regulations, policies and guidelines
• Knowledge in one or more of the following key therapeutic areas is considered an asset: CV-Metabolism, Oncology, Respiratory/Inflammation and Infection.
• Minimum 3-5 years regulatory experience in the brand name pharmaceutical or biotechnology industries
• Minimum 2 years regulatory project management experience
• Negotiation skills
• Excellent time management and organizational skills (ability to manage multiple projects and priorities effectively)
• Excellent written and verbal communication skills
• Business acumen, such as writing business proposals and project plans
• Risk identification and management
• Interpersonal and relationship building skills
• Ability to participate in collaborative teamwork
• Detail oriented
• Problem solving ability and innovative strategic thinking
• Customer-focused
• Proficient in the use of MS Office

 This is a career role, not just another job. To express interest in this opportunity, please contact Rebecca Liu at rebecca.liu@thetalent.co. As always, referrals are gratefully received.
 
About The Talent Company
The Talent Company is an HR Solutions Firm. We work closely with our clients to FIND, KEEP, REWARD and TRANSITION their talent. We act as a trusted search partner for leading organizations providing customized and timely recruitment services.  For a list of our current opportunities, click here.
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