Labelling Hub Manager

Mylan Pharmaceuticals ULC

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Every day, we rise to the challenge to make a difference and here’s how the Labelling Hub Manager will make an impact:

Key responsibilities for this role include:

Prepares new and revised product labeling for New Drug Submissions (NDS). This includes preparing original labeling or revising existing labeling in response to Health Authority comments/guidances/regulations, changes in reference product approved labeling, or in support of launch and/or rebranding activities.

Preparation and submission of original or revised labeling documents to Health Authority, as appropriate. Must demonstrate ability to independently research projects and engage appropriate departments/subject matter experts to finalize labeling that is accurate and meets regulatory requirements.

Review Company Core Data Sheets and assess the impact to the Product Monograph and associated labeling documents.

Interacts with multiple departments within Company, as well as third parties, as appropriate, to create labeling that meets both regulatory, legal and commercial/marketing requirements.

Demonstrates the ability to complete/execute standard labeling projects independently and demonstrates ability to complete these projects expeditiously while maintaining high quality output.

Responsible for leading/completing extraneous special projects outside of the realm of standard submissions to Canadian Health Authority, as assigned.

Responsible for  internal software systems in support of the labeling submission process, such as D2 and TrackWise, etc. May serve as departmental superuser/subject matter expert (SME).

Maintains current knowledge of Health Authority regulations and guidances pertaining to labeling by utilizing the Health Authority website and via attendance at conferences.

Independently interpret new guidances and impact on Company’s portfolio and effectively communicate impact to the business.

Performs other duties as assigned.

The minimum qualifications for this role are:

A strong understanding of Health Canada drug product legislation and guidelines, along with knowledge of the regulatory process pertaining to drug labeling as well as possess an understanding of related medical terminology.

Must have excellent project management skills, ability to manage several different projects simultaneously (with varying degrees of complexity), strong work ethic, consensus gathering skills, and strong written and verbal communication skills. Must be well organized, demonstrate exceptional attention to detail, and be capable of providing support to others. Applicable computer skills in a Microsoft Office-based environment are also necessary, along with working knowledge of TrackWise and D2. Must know the electronic submission requirements for labeling documents in Module 1 for the Canadian Health Authority.

Must understand Submission Content Plans and ability to work in a Document Controlled System such as Documentum or D2.

Must know general regulatory submission strategies and be able to participate in discussions about labeling submission strategy to the Health Authority.

Understands end to end labeling to artwork implementation including general artwork process and terminology.

Minimum of a Bachelor's degree (or equivalent) and 4-6 years of experience.  However, a combination of experience and/or education will be taken into consideration.

A t Viatris, we offer   competitive   salar ies , benefits   and   an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, ancestry, place of origin, colour, ethnic origin, citizenship, creed, sex, sexual orientation, gender identity, gender expression, age, record of offences, marital status, family status, disability or any other characteristic, protected by local, provincial, or federal laws, rules, or regulations.