At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.
Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
The Sr. Manager, Regulatory Affairs has responsibility to provide comprehensive regulatory services for clients requiring support for registration and maintenance activities in the respective regions for pharmaceuticals, biologics, and other product types. This role involves leading the preparation, filing and maintenance of regulatory submissions as well as management of clients.
- Effectively-prepare regulatory files and provide support for maintenance activities in adherence with applicable legislation, and guidelines facilitating approvals and continued client compliance.
- Prepares Health Canada NDSs, SNDSs, CTAs and post-approval submissions for pharmaceuticals and biologics.
- Experienced with performing Module 2 updates and labelling strategy and development.
- Manages and ensures maintenance of a positive and productive liaison with internal and external contacts, including regulatory agencies, clients, and related institutions.
- Lead/attend formal interactions (face-to-face meetings, teleconferences, etc.) with clients and, possibly, government agencies.
- Develops initial or alternative regulatory strategies consulting with their manager and other resources within the organization as needed. Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.
- Responsible for managing project workflow including prioritizing project objectives, and establishing timeframes for projects with clients. Responsible for overseeing progress and completion of projects with project team members, ensuring timeframes and deadlines are met.
- Lead, participate in and support project teams related to regional filings and maintenance activities across a range of product types.
- Effectively prioritize and complete multiple projects within established timeframes.
- Proactively monitors for new regulatory requirements and shares key learnings.
- Train or mentor others to build team expertise across various product types.
- This role will prepare quotations for projects that may cross multiple service areas within the company and manage projects within budget preparing change orders as needed.
- Proactively improve business processes and tools to facilitate provision of core services.
- Ability to work off site at client occasionally may be needed.
- Ability to travel (10%) as necessary, passport required.
Required experience:
- Minimum of BS in Life Science, healthcare, engineering preferred
- Minimum of 8-10 years of relevant experience, i.e. pharmaceutical drug with regulatory experience in the local environment.
- Experienced and knowledgeable with Health Canada regulations, guidelines and submission preparation
- Awareness/knowledge of international guidelines as appropriate, such as GMP, GCP, GxP, ICH
- Ability to maintain a high level of accuracy and attention to detail.
- Effective project management skills.
- Awareness of business development process.
- Growing problem solving, judgment and decision-making skills to seek creative solutions to issues surrounding on-time, on-budget and high quality project outcomes.
- Excellent planning, organization, interpersonal, time and change management skills.
- Medical writing experience an asset.
- Consulting experience is an asset.
- Communication, verbal and written: able to convey thoughts in a clear, concise and accurate manner; use appropriate regulatory medical and scientific nomenclature; listen carefully and ask questions when necessary to ensure understanding; proactively share experience/expertise with others
Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
