Senior Associate Regulatory Affairs

4 weeks ago

Etobicoke, Canada Viatris Full time
Mylan Pharmaceuticals ULC

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:

– Providing high quality trusted medicines regardless of geography or circumstance;

– Advancing sustainable operations and innovative solutions to improve patient health; and

– Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here’s how the Senior Associate Regulatory Affairs role will make an impact:

Key responsibilities for this role include:

Assist in compiling pre-submission meetings, initial submissions (ANDS / NDS) and life-cycle submissions (NC, SANDS, SNDS) that meet the target dates for submission to Health Canada. Address deficiencies and help manage the response strategy to listed and potential deficiencies.

Provide technical and strategic support to Global R&D for the filing of complex Brand and generic drug products (including biosimilars) 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.

Coordinate with the manufacturing sites on proposed post-approval changes to ensure compliance for the pharmaceutical products. Review and accurately assess change controls to determine the accurate level of change. 

Prepare Annual Notifications, Pharmacovigilance (PV) submissions and Administrative Submissions within target dates.

Maintain Product Information databases.

Provide regulatory support for launch and release activities.

Ensure regulatory compliance for a diversified and complex group of products. 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, Supply Chain and Legal to provide regulatory support to achieve high quality submissions that reflect the business needs of all relevant areas of the company.

Participate in the training of Regulatory Affairs Associates.

The minimum qualifications for this role are:

Minimum of 3 (preferably 3-8) years hands-on experience in regulatory submission preparation in the Canadian pharmaceutical industry.

B.Sc. or equivalent in a related (health science) discipline.

Pharmaceutical Regulatory Affairs Graduate Certificate considered an asset.

Regulatory Affairs Certification (RAC) considered an asset.

Strong knowledge of the Canadian regulatory environment and Health Canada regulations, guidance documents and policies. Strong negotiation skills.

Process oriented, logical, analytical, problem solving; able to analyze data and implement solutions.

Highly organized, meticulous and capable of multi-tasking various projects/timelines at one specific time.

Excellent oral and written communication skills.

Strong leadership and managerial skills in leading cross-functional teams and providing regulatory expertise to internal and external stakeholders.

Be able to work independently, strong sense of accountability and motivated to achieve goals.

Detail oriented.

Proficiency with Microsoft Office and Document Management Systems.

At Viatris, we offercompetitivesalaries, benefitsandan 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.

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