Job Description

7509 BGP Pharma ULC (EPD Canada)

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:

Access \xe2\x80\x93 Providing high quality trusted medicines regardless of geography or circumstance;

Leadership \xe2\x80\x93 Advancing sustainable operations and innovative solutions to improve patient health; and

Partnership \xe2\x80\x93 Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here\xe2\x80\x99s how the Project Manager, Regulatory Affairs role will make an impact:

Key responsibilities for this role include:

Lead in the compilation of pre-approval (ANDS/ NDS) and post-approval (NC, SANDS, SNDS) submissions that meet the target dates for submissions to Health Canada. Address deficiencies and manage the response strategy to listed and potential deficiencies by working closely with the Global R&D sites, Quality and Commercial team to ensure the benefit of the Canadian business.

Provide technical and strategic support to Global R&D for the filing of complex generic/biologic/ biosimilar drug products to achieve high quality submissions to meet the business needs.

Communicate effectively with Health Canada and with internal and external clients to support the drug review and approval process.

Actively involved in pre-submission or product specific discussion meetings with Health Canada in terms of preparing presentations with the R&D team and being an active participant in the discussion.

Work independently and proactively to review pre-approval and post-approval decisions based on the Canada market needs and keep all the relevant departments appraised of updates as needed.

Coordinate with the manufacturing sites on proposed post-approval changes to ensure compliance for the pharmaceutical and biological products.

Prepare Annual Reports, for pharmaceutical and Biological (YBPRs) drugs within the target submission dates.

Maintain Product Information databases.

Provide regulatory support for launch activities.

Ensure compliance for a large group of products. Review and accurately assess change controls to determine the appropriate level of change. Maintain Compliance files to keep track of current documents for QA Inspection and product release. Ensure Product Monographs and labeling materials remain up to date.

Liaise with several departments including Global R&D, Operations, Marketing, Quality and Legal to provide regulatory support to achieve high quality submissions that reflect the business needs of all relevant areas of the company.

Provide guidance and support to Regulatory Affairs Associates and Regulatory Affairs students.

The minimum qualifications for this role are:

B.Sc. in one of the life sciences or chemistry with a minimum of 10 years hands-on experience in regulatory submission preparation.

Experience in filing biological drug submissions an asset.

Post-Graduate Regulatory Affairs Certificate considered an asset.

Strong knowledge of Health Canada regulations and guidelines requirements.

Experience with documentation, organizing small projects, working in a deadline environment.

Proven ability to learn, correlate diverse data and extrapolate from set examples; documented organizational abilities.

Demonstrated time management skills and the ability to prioritize and handle multiple projects is required.

Excellent analytical, communication and interpersonal skills.

Proficiency with Microsoft Office and Document Management Systems.

At Viatris, we offer competitive salaries, 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.

Viatris