Regulatory Project Manager (Remote)

Regulatory Project Manager | Quality Smart Solutions Inc. | Worldwide

Regulatory Project Manager

About Quality Smart Solutions

Quality Smart Solutions Inc. is a science and compliance consulting firm globally serving consumer health product companies in Natural Health Products, Dietary Supplements, Over-The-Counter DIN products, GRAS, Foods and Cosmetics regulatory and quality areas.

Our fast, cost effective, solutions-oriented approach has ensured client satisfaction and has established Quality Smart Solutions as the preferred partner in science and compliance having served over 600 global clients, licensing over 5000 products and sites and completed over 15,000 projects.

Job Description:

Reporting to the Senior Manager of Regulatory Affairs & Operations, the Regulatory Project Manager will be managing all projects and working with international clients to schedule projects, manage timelines/client expectations, track billable time and ensure projects are carried out diligently and timely for our clients. The position is a full-time, remote based position.

Responsibilities:

• Managing and handling project setup of all projects across business divisions
• Managing all project related requests internally to ensure timely and high-quality deliverables to clients
• Initiating documentation intake for label projects, various Post License requests and external contractor services
• Managing renewals periods for all recurring services that require periodic renewal (ie. MDEL, FDA Agent, QIS NHP, VHP Canadian representative service)
• Engaging cross functionally between company departments (ie. sales, accounting, regulatory affairs) to ensure communication flow remains open and efficient to support project throughput.
• Liaising with accounting personnel to review past due balances for all regulatory services
• Manage and monitoring all billable time of the technical team to ensure project margin targets are met with respect to overall profitability of services
• Managing client requests with respect to complaints, timelines, document requests, and overall expectation management during delivery of services
• Ensuring all project trackers are being regularly updated by regulatory and administrative team members to ensure accurate project status visibility for management team
• Reviewing quotations and invoice materials to ensure verbiage is accurate and reflective of true project-scope
• Delivering various project deliverables to clients within agreed timelines between Subject-Matter-Expert (SME) and client
• Monitoring all SMEs progress within respect to project timelines, internal requests, email response times, and project deliverables (within Wrike and other company tools–email, sales team requests, etc)
• Support the management team hiring process to scout for new staff, job postings, interviews, etc
• Ensure that budgets are being maintained across respective lines of business eg. ensure projects are not going out of scope of BT
• Collaborate with marketing teams to facilitate social media and website content for regulatory services and updates.
• Reporting upwards to management with any relevant process fixes, pain points, improvements, as they arise in real-time
• Negotiating hourly rates with subcontractors and staff to safeguard operational costs ensuring project and category profitability for the company
• Onboard new team members with various company tools
• Managing project transitions for outgoing SMEs
• Provide open feedback to management on staff issues, client issues as they arise
• Provide weekly bandwidth reports to Sr. RA/Ops Manager

Experience/Skills/Education qualifications:

• Undergraduate university degree or Diploma/ Post Graduate certificate in project management
• PMP and/or scrum certification
• 3-5+ years experience in project management. Experience in a consulting firm environment an asset
• Experience with QuickBooks an asset
• Good understanding of financial concepts to facilitate cost, project margins, and billable time tracking
• Regulatory Affairs experience an asset
• Experience in the Pharma and Consumer Packaged Goods industry considered an asset.
• Fluent in English writing, reading and speaking a requirement. French is a bonus.
• Must be a confident, decisive thought-leader in difficult/grey area situations.
• Must demonstrate integrity and ownership over project related decisions as they arise.
• Must be able to work collaboratively in a team setting both internally whilst having excellent client relation skills.
• Comfortable in fast-paced, but highly supportive work environment.
• Computer skills in internet search engines, Microsoft Word, Excel
• Excellent verbal and written and grammatical skills
• Excellent problem recognition and resolutions skills
• Can quickly learn new regulations and applications procedures as per client requests
• Ability to work independently with little supervision
• Ability to handle multiple projects and meet deadlines and client deliverables
• Attention to detail and high level of accuracy and consistency.
• Must be highly organized thinker and worker who is always thinking about process improvement—must be able to quickly and clearly identity challenges interfering with project throughput.
• Must be comfortable in managing conflicts with clients whilst communicating project needs to fulfill work scope to internal regulatory staff

Quality Smart Solutions is an equal opportunity employer.

Please email your resume to careers@qualitysmartsolutions.com with the Subject title: Regulatory Project Manager role or fax to 480-393-5627.

Job Type: Full-time

Pay: Up to $85,000.00 per year

Benefits:

• Company events
• Dental care
• Extended health care
• Work from home

Flexible language requirement:

• French not required

Schedule:

• Monday to Friday

Education:

• Bachelor’s Degree (preferred)

Experience:

• Project management: 3 years (preferred)

Language:

• English (required)

Work Location: Remote

Tagged as: remote, remote job, virtual, Virtual Job, virtual position, Work at Home, work from home