Senior Associate Regulatory Affairs (12-14 month) contract

Mylan Prescription 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 individuals worldwide to stay 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 individuals to services and products. 

Each day, we rise to the problem to make a distinction and right here’s how the position will make an influence:

Key obligations for this position embody:

• 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 help 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 shoppers to help 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. Assessment 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.
• Preserve Product Info databases.
• Present regulatory help for launch and launch actions.
• Guarantee regulatory compliance for a diversified and complicated group of merchandise. Preserve compliance information 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, High quality, Provide Chain and Authorized to supply regulatory help 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 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.
• Robust information of the Canadian regulatory surroundings and Well being Canada rules, steering paperwork and insurance policies. Robust negotiation abilities.
• Course of oriented, logical, analytical, drawback fixing; capable of analyze knowledge and implement options.
• Extremely organized, meticulous and able to multi-tasking numerous initiatives/timelines at one particular time.
• Glorious oral and written communication abilities.
• Robust management and managerial abilities in main cross-functional groups and offering regulatory experience to inside and exterior stakeholders.
• Have the ability to work independently, robust sense of accountability and motivated to realize objectives.
• Element oriented.
• Proficiency with Microsoft Workplace and Doc Administration Programs.

At Viatris, we provide aggressive salaries, advantages and an inclusive surroundings the place you should use your experiences, views and abilities 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, fatherland, color, ethnic origin, citizenship, creed, intercourse, sexual orientation, gender id, gender expression, age, document of offences, marital standing, household standing, incapacity or another attribute, protected by native, provincial, or federal legal guidelines, guidelines, or rules. 

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