Project Leader, Regulatory Affairs Operations

7 months ago

Toronto, Canada Calea Ltd. Full time

***

The Project Leader, Regulatory Affairs Operations is responsible for the management of regulatory operational activities to support Regulatory Affair Department in effective regulatory submissions and timely regulatory approvals. The Project Leader leads Regulatory Operations day to day electronic submission activities and all tasks related to data collection, data management, data reporting and database management for the Regulatory Affairs Department.

**PRINCIPAL ACCOUNTABILITIES**
- Commits to being fully engaged, caring, and enthusiastic about the organization and its goals
- Fosters a work environment conducive to an engaged team; leading by example and managing by engagement principles and learnings
- Commits to living the core Company values of:

- Customer Focus - We put customers first
- Quality - We demand excellence
- Integrity - We are trustworthy
- Collaboration - We work well together
- Creativity - We deliver solutions
- Passion and Commitment - We care
- Adheres to corporate, regulatory and individual responsibilities supporting the Company’s quality management programs, supporting policies, procedures, work instructions, and relevant software (Documentum).
- Adheres to the Company’s commitment and to policy on Code of Conduct
- Adheres to organizational and individual health and safety responsibilities in the workplace
- Maintains up-to-date health and safety training
- Maintains up-to-date training assigned for this position via Kabi LIFT Learning Management System and position specific training as required
- Supports and coaches team members to meet the Company’s expectations for productivity and quality
- Actively pursues ways in which to improve the function of the Regulatory Affairs Department
- Communicates directly with RA leadership on proposed improvements
- Oversees regulatory e-submissions or regulatory-related projects within local and Share Service Center RA Ops teams
- Evaluates the publishing needs in relationship to the overall project timelines, quality and delivery
- Plans and monitors each task throughout a project to ensure it is completed in a timely manner
- Manges RA activities to maintain and improve the regulatory SharePoint site
- Oversees all regulatory information relevant logs, trackers, and archives of regulatory submissions, correspondence, and commitments
- Leads the development and implementation of standard procedures for publishing, archiving, metrics, and e-submission processes
- Coordinates Annual Drug Notifications for Fresenius Kabi Products
- Liaisons with the Global SDM Project Teams and identifies Canadian needs
- Monitors and assesses business trends, regulations or guidance documents, and emerging technologies for potential regulatory operations impact and develops proposal for business implementation

**RELATIONS WITH OTHERS**
- Internally there is interaction with staff and management of all local and regional internal departments including but not limited to Quality, Finance, Human Resources, Supply Chain Management, Customer Service, Sales, Marketing and Vigilance as applicable
- Externally there is interaction with Health Canada directorates

**QUALIFICATIONS**
- Minimum Bachelor of Science Degree in one of the following is required: Chemistry, Microbiology, Biology, Pharmacology or other life science
- Completion of a college regulatory affairs program is an asset
- Minimum four years of pharmaceutical experience in a regulatory affair publishing capacity
- Proven leadership skills

**SKILLS**
- Strong working knowledge of regulations and guidelines governing electronic submissions.
- Working knowledge of Health Canada regulations and understanding of Global regulatory requirements
- Highly proficient in using Microsoft Word, Excel, and Acrobat Adobe (PDF), as well as EDMS and eCTD publishing software
- Strong knowledge of electronic templates and skilled in formatting and troubleshooting templates
- Excellent communication skills (written and verbal)
- Excellent customer service skills and the ability to collaborate with all levels both inside and outside the organization
- Excellent continuous improvement skills
- Leadership skills
- Excellent project organization skills
- Strong time management and ability to multitask
- Strong attention to details
- Analytical skills to assess problems and present solutions are required
- Ability to exercise independent judgment in developing methods, techniques and evaluation of criteria using defined procedures and practices
- Strong commitment to quality, accuracy, and detail
- Ability to work well under pressure in a team-based environment
- Proven ability to adhere to standards and procedures and maintain confidentiality

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