Regulatory Affairs Manager - OTC

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The 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, medical devices 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 Natural Health Product submissions, Cosmetics notifications, DIN applications, Rx to OTC switch submissions
• Experience with label reviews
• Prepares Health Canada NDSs, SNDSs, CTAs and post-approval submissions
• 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 6-8 years of relevant experience, i.e. pharmaceutical drug with regulatory experience in the local environment.
• OTC experience with Health Canada is an asset
• 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.
• Highly self-motivated and proactive
• Ability to work independently
• Proficiency in MS-Office applications including Microsoft Word, Excel and PowerPoint
• 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
• Attention to detail: identifies and resolves discrepancies across various source documents including published and unpublished documents; note and resolve errors in written documentation
• Planning and organizing ability: plans work effectively to meet goals and ensure timely completion of assignments; manages time effectively, using a system for completing work; consistently meets timelines and works within budget; proactively discusses workload issues with manager.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, 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.