Senior Associate Regulatory Affairs (12-14 month) contract


Mylan Prescribed drugs ULC

At VIATRIS, we see healthcare not as it’s however correctly. We act courageously and are uniquely positioned to be a supply of stability in a world of evolving healthcare wants.

Viatris empowers folks worldwide to dwell more healthy at each stage of life.

We accomplish that through: 

  • Entry – Offering prime quality trusted medicines no matter geography or circumstance;
  • Management – Advancing sustainable operations and modern options to enhance affected person well being; and 
  • Partnership – Leveraging our collective experience to attach folks to services. 

Day-after-day, we rise to the problem to make a distinction and right here’s how the position will make an impression:

Key duties for this position embrace:

  • Help in compiling pre-submission conferences, preliminary submissions (ANDS / NDS) and life-cycle submissions (NC, SANDS, SNDS) that meet the goal dates for submission to Well being Canada. Deal with deficiencies and assist handle the response technique to listed and potential deficiencies.
  • Present technical and strategic assist to International R&D for the submitting of complicated Model and generic drug merchandise (together with biosimilars) to attain prime quality submissions to satisfy the enterprise wants.
  • Talk successfully with Well being Canada and with inner and exterior shoppers to assist the drug assessment and approval course of.
  • Coordinate with the manufacturing websites on proposed post-approval adjustments to make sure compliance for the pharmaceutical merchandise. Evaluate and precisely assess change controls to find out the correct degree of change. 
  • Put together Annual Notifications, Pharmacovigilance (PV) submissions and Administrative Submissions inside goal dates.
  • Keep Product Data databases.
  • Present regulatory assist for launch and launch actions.
  • Guarantee regulatory compliance for a diversified and sophisticated group of merchandise. Keep compliance recordsdata to maintain monitor of present paperwork for QA Inspection and product launch. Guarantee Product Monographs and labeling supplies stay updated.
  • Liaise with a number of departments together with International R&D, Operations, Advertising and marketing, High quality, Provide Chain and Authorized to offer regulatory assist to attain prime quality submissions that replicate the enterprise wants of all related areas of the corporate.
  • Take part within the coaching of Regulatory Affairs Associates.

The minimal {qualifications} for this position are:

  • Minimal of three (ideally 3-8) years hands-on expertise in regulatory submission preparation within the Canadian pharmaceutical trade.
  • B.Sc. or equal in a associated (well being science) self-discipline.
  • Pharmaceutical Regulatory Affairs Graduate Certificates thought of an asset.
  • Regulatory Affairs Certification (RAC) thought of an asset.
  • Robust information of the Canadian regulatory atmosphere and Well being Canada laws, steering paperwork and insurance policies. Robust negotiation expertise.
  • Course of oriented, logical, analytical, downside fixing; capable of analyze information and implement options.
  • Extremely organized, meticulous and able to multi-tasking numerous initiatives/timelines at one particular time.
  • Glorious oral and written communication expertise.
  • Robust management and managerial expertise in main cross-functional groups and offering regulatory experience to inner and exterior stakeholders.
  • Be capable to work independently, robust sense of accountability and motivated to attain objectives.
  • Element oriented.
  • Proficiency with Microsoft Workplace and Doc Administration Methods.

At Viatris, we provide aggressive salaries, advantages and an inclusive atmosphere the place you should use your experiences, views and expertise to assist make an impression on the lives of others. 

Viatris is an Equal Alternative Employer. All certified candidates will obtain consideration for employment with out regard to race, ancestry, native land, color, ethnic origin, citizenship, creed, intercourse, sexual orientation, gender id, gender expression, age, report of offences, marital standing, household standing, incapacity or another attribute, protected by native, provincial, or federal legal guidelines, guidelines, or laws. 

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