Role posted on: 9th November 2018
We are recruiting for experienced regulatory project managers who have a proven track record of successful submissions of new products and line extensions from Phase 0 through marketed products.
As the Regulatory landscape becomes more complex, the industry has to respond with new ways to develop drugs. The Health Authorities are continually implementing new Regulations that require extensive change in our business processes.
This role involves project managing strategic projects focusing on innovation, efficiencies, compliance and business process improvement within and beyond.
Role Description: Regulatory Program Manager – Mississauga
- Manage global projects to simplify how we conduct our business, enable compliance with the Regulations and optimize innovation. Apply knowledge in project management to independently address complex problems.
- Develop, evaluate and manage business case and cost/ benefit analyses.
- Drive discussions with business partners to define and deliver project scope and charter.
- Define approach to project delivery and develop the associated project plans and timelines.
- Lead the execution of the project and deliver projects on budget, on schedule, and with deliverables that meet or exceed customer expectations. Raise issues and drive issues to resolution. Implement and oversee risk management practices on the project.
- Identify and recommend project deliverables that address the root cause of complex problems. Lead development of relevant Project Management deliverables.
- Provide change management guidance to ensure sustainable transformation. Ensure Change Management best practices are incorporated throughout the project delivery.
- Proactively communicate with stakeholders regarding project status, financial health, risks and mitigation of issues, and dependencies across projects.
- Facilitate process improvement activities on projects using operational excellence methodologies and tools.
- Manage multiple projects and prioritize workload in accordance with business goals.
- Contribute to the improvement of the portfolio & organizational development function via updating deliverables, sharing knowledge and enhancing tools and techniques.
- Three or more years of related experience in project management or strategic consulting in cross-functional projects is required; experience in drug development projects pharmaceutical/biotech industry is preferred; experience supporting a global team is a plus.
- Proficiency with common project management tools such as MS Project is required. PMP (Project Management certification) or equivalent, Change Management certification and Process certification is a plus.
- Ability to foster a collaborative environment.
- Excellent planning and prioritization skills with the ability to multi-task and adapt to a changing environment.
- Strong communication skills in English, demonstrated ability to communicate effectively in a multifunctional and global environment.
- Proven track record in driving change.
- Strong analytical skills, including ability to clearly define problem statements and define new processes/deliverables to meet project objectives.
- Ability to take complex ideas, processes, and requirements and share critical elements in a concise and accurate manner in writing and through presentations.
If you would be interested in joining the team at G&L Scientific, please send your CV to talent @ gandlscientific.com today.
G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.