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Specialist Data Maintenance Regulatory Affairs

Company

Viatris
Address , Remote
Employment type FULL_TIME
Salary $41,000 - $93,000 a year
Expires 2023-07-17
Posted at 11 months ago
Job Description
1000 Mylan Inc.
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:
  • Access – Providing high quality trusted medicines regardless of geography or circumstance;
  • Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
  • Partnership – 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 Specialist, Data Maintenance Regulatory Affairs role will make an impact:
Key responsibilities for this role include:
  • Builds knowledge of electronic and paper publishing systems and tools and applies these tools to produce CMC change management outputs.
  • In accordance with required standards and timelines, enters and maintains critical regulatory information related to assigned CMC change management activities within the CMC dossier management system.
  • Partners with Regulatory and CMC Strategists to effectively communicate change statuses to impacted stakeholders through the use of regulatory systems and data maintenance standards.
  • Supports Global Regulatory Affairs integration activities, as needed.
  • Adheres to the required use of technical tools and working practices and utilizes QC/QA regimes to ensure regulatory and internal process compliance.
  • Supports submission planning activities using regulatory submission planning tool(s).
  • Perform other duties as assigned.
The minimum qualifications for this role are:
  • Must possess strong written and verbal communication skills, interpersonal skills, management skills, strong work ethic, strong attention to detail and a working knowledge of Microsoft Office including Word, Excel, Powerpoint, Adobe and D2. Additionally, must possess a strong ability to learn and apply processes, systems and standards as related to electronic dossier management and be able to manage and plan workload under competing priorities and tight timelines.
  • Minimum of a Bachelor's degree (or equivalent) and 2-4 years of experience. However, a combination of experience and/or education will be taken into consideration.
  • Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group of departments.
  • Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
  • Must possess knowledge of general submission / registration planning as it relates to change management activities. Requires specific knowledge of the CMC process as it relates to CMC CTD content and Change Management processes/systems. Must have experience working in a highly regulated environment and have experience with adherence to GMP, GLP or GCP related SOPs and Work Instructions, as well as authoring these and associated training documents.
  • Proficiency in speaking, comprehending, reading and writing English is required.
  • Ability to perform computations such as percentages, ratios, and rates.
Exact compensation may vary based on skills, experience, and location. The salary range for this position is $41,000 - $93,000.
At Viatris, we offer competitive salaries, benefits and an 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, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.
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