Senior Associate, Regulatory Affairs


Mylan Prescription drugs ULC

At VIATRIS, we see healthcare not as it’s however accurately. 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 progressive options to enhance affected person well being; and 
  • Partnership – Leveraging our collective experience to attach folks to services and products. 

Daily, we rise to the problem to make a distinction and right here’s how the Senior Affiliate, Regulatory Affairs position will make an influence:

Key tasks 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 complicated Model and generic drug merchandise (together with biosimilars) to realize prime quality submissions to satisfy the enterprise wants.
  • Talk successfully with Well being Canada and with inside and exterior shoppers to assist the drug evaluate and approval course of.
  • Coordinate with the manufacturing websites on proposed post-approval adjustments to make sure compliance for the pharmaceutical merchandise. Evaluation 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.
  • Preserve Product Data databases.
  • Present regulatory assist for launch and launch actions.
  • Guarantee regulatory compliance for a diversified and sophisticated group of merchandise. Preserve 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, High quality, Provide Chain and Authorized to supply regulatory assist to realize prime quality submissions that mirror 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 business.
  • 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.
  • Robust information of the Canadian regulatory surroundings and Well being Canada laws, steering paperwork and insurance policies. Robust negotiation expertise.
  • Course of oriented, logical, analytical, downside fixing; in a position to analyze information and implement options.
  • Extremely organized, meticulous and able to multi-tasking varied tasks/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 inside and exterior stakeholders.
  • Be capable of work independently, sturdy sense of accountability and motivated to realize objectives.
  • Element oriented.
  • Proficiency with Microsoft Workplace and Doc Administration Techniques.

At Viatris, we provide aggressive salaries, advantages and an inclusive surroundings the place you need to use your experiences, views and expertise to assist make an influence 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 some other attribute, protected by native, provincial, or federal legal guidelines, guidelines, or laws. 

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