Senior Associate Regulatory Affairs (12-14 month) contract

Viatris

jobsincanada.one

Mylan Prescribed drugs ULC

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

Viatris empowers individuals worldwide to reside more healthy at each stage of life.

We achieve this 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 individuals to services and products. 

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

Key obligations 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. Tackle 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 advanced Model and generic drug merchandise (together with biosimilars) to realize prime quality submissions to fulfill the enterprise wants.
  • Talk successfully with Well being Canada and with inside and exterior purchasers to assist the drug assessment and approval course of.
  • Coordinate with the manufacturing websites on proposed post-approval modifications to make sure compliance for the pharmaceutical merchandise. Assessment and precisely assess change controls to find out the correct stage of change. 
  • Put together Annual Notifications, Pharmacovigilance (PV) submissions and Administrative Submissions inside goal dates.
  • Keep Product Info databases.
  • Present regulatory assist for launch and launch actions.
  • Guarantee regulatory compliance for a diversified and sophisticated group of merchandise. Keep compliance information to maintain observe 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 realize 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-about an asset.
  • Regulatory Affairs Certification (RAC) thought-about an asset.
  • Sturdy information of the Canadian regulatory atmosphere and Well being Canada rules, steerage paperwork and insurance policies. Sturdy 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.
  • Wonderful oral and written communication expertise.
  • Sturdy management and managerial expertise in main cross-functional groups and offering regulatory experience to inside and exterior stakeholders.
  • Be capable to work independently, robust sense of accountability and motivated to realize targets.
  • Element oriented.
  • Proficiency with Microsoft Workplace and Doc Administration Programs.

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, hometown, color, ethnic origin, citizenship, creed, intercourse, sexual orientation, gender identification, gender expression, age, document of offences, marital standing, household standing, incapacity or every other attribute, protected by native, provincial, or federal legal guidelines, guidelines, or rules. 

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