Regulatory Affairs Project Manager Jobs

Intermediate project management, time management and organizational skills

4 -10 years’ related experience and/or training or equivalent combination of education and experience

Advanced knowledge of the electricity regulated industry or equivalent experience with emphasis on rate design and cost allocation methodologies

Intermediate knowledge of Occupational Health and Safety requirements as it relates to individual, organizational and operational requirements

Senior Manager of Regulatory Affairs and Risk Management.

8 years’ experience in a supervisory role

University Degree/Professional Designation or equivalent learning and experience in a related discipline (i.e. Management; RAC)

Effective communication with all stakeholders, including customers and government authorities. Abilities should include excellent presentation, writing, and editing skills.

Fundamental Skills, Abilities & Attributes

Manage and lead recalls vigilance procedures, health risk assessments.

Strong knowledge and understanding of cGMP, ISO 13485, MDSAP and IVDR guidelines, policies, and regulations

Technical knowledge of in-vitro diagnostic products

Experience in team and project management.

Manage safety updates to product monographs.

Maintain up-to-date knowledge of applicable company SOPs, guidelines, and work instructions as they relate to product labeling.

Understand the BPM audit process and requirements.

Minimum 3 years' experience (pharmaceutical industry, an asset).

Strong communication and negotiation skills.

Previous Project Management experience is an asset

Previous experience with the development and implementation of a Restricted Substances List or related chemicals management programs is an asset

In collaboration with the Chemicals Management Team, ensure regulated standards are reflected in annual updates to lululemon’s Restricted Substances List

Experience with national and/or international chemical laws and regulations applicable to adult apparel and accessories, , foods, electronics and equipment

Experience with regulatory, government and industry or standards organizations

Experience with legal and regulatory action is desired

• 8 years of combined previous experience as a Project Manager/Project Coordinator or related field

• Working in tandem with another Project Manager to support the initiative

• 4+ years of previous experience with regulatory & business projects

• Experience with MS Project Plan/PowerBI

• Experience with Excel & MS Office

• Previous experience in the financial industry

Project management & organizational skills

Regulatory Inquiries and Examinations Management:

10 to 15 years’ experience in financial sector. The role is open to Senior VPs who would meet the requirements below.

Ability to work both independently and collaboratively with members of the management team and other colleagues across the bank

Ability to interact with experienced managers (COO, CEO level) and provide effective briefs on risks and issues

Sharing knowledge with the business and organizing preliminary impact analysis

Develop and implement effective recall management procedures and processes.

Demonstrated leadership skills and experience in managing and mentoring a team.

Familiarity with quality management systems (e.g., MDSAP, QSR, GMP) and risk management (e.g., ISO 14971).

Quality Management System (QMS) Activities:

Ensure adherence to regulatory requirements throughout the product lifecycle.

Lead cross-functional teams in executing product recalls, ensuring compliance with regulatory requirements.

• Acts as a knowledgeable resource on limited topics to other Regulatory Affairs personnel within the department.

• Post-graduate certification in Regulatory Affairs is considered an asset.

• Experience in Virology or Oncology considered an asset

• Understanding and knowledge of the fundamentals of Canadian regulatory legislation and guidance.

• Excellent communication skills both in writing and verbally.

• Good judgment/ problem solving skills.

Strong business analysis and project management skills required, including a deep understanding of translating customer business needs into technology requirements.

5+years business and/or technology experience, including business analyst or project manager in a pharmaceutical, technical, financial (or other regulated) industry.

Analyze business needs, bring together, document and assess business requirements from partners and define a case for a technology solution.

Develop and monitor continuous improvement activities, including measuring existing systems against changing business requirements to determine enhancements and process improvements.

Minimum 3 years’ experience in Pharmaceutical / Life Sciences regulated environment (GxP) QC, Clinical/Medical or Drug Safety experience.

Solid understanding of medical/clinical terminology, roles and responsibilities

Project management skills with a demonstrated ability to write detailed technical reports;

Evaluating Request for Proposals and prepare responses, develop work scopes, budgets and schedules, and providing project management;

Willingness to occasionally travel, including to remote locations and outside standard office hours;

Managing projects related to renewable energy, transportation, industrial development, infrastructure, mining and oil and gas sectors;

Managing projects and our clients simultaneously while fostering a collaborative and inclusive team environment;

Acting as a mentor for junior staff and collaborate regionally and nationally with other EIA practitioners;

Experience preparing regulatory submissions, license applications, registrations and other product approval documentation and demonstrated knowledge of applicable requirements and practices.

Management Representative; responsible for implementation, governance, performance reporting, and maintenance of Ventripoint’s quality management system.

Ensure compliance with GMPs, and applicable regulatory requirements related to product importation, release and distribution in Canada, United States, and Europe.

Manage preparation and implementation of new SOPs. Manage CAPAs, deviations, and out-of-specification investigations.

Manage preparation and review of validation protocols and reports.

Experience developing regulatory strategies and plans.

Experience with the concepts, principles, practices, and methodologies of policy and regulatory analysis.

Strong analytical and communication skills.

Strong project coordination and research skills.

Strong computer skills including proficiency with MS Office and other related software.

Comprehensive group benefits plan, including health/dental, life insurance, LTD, and company-matched RRSP contributions

Job Title:Manager, Health Product Regulatory Affairs