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 Manager, IT Regulatory Systems role will make an impact:
Regulatory Systems Manager position partners with Global Regulatory Affairs functions to understand technology needs, ensure global RIM processes and Regulatory systems are compliant and representative of cross functional business needs. The successful candidate will demonstrate strong global Regulatory Affairs domain expertise, have hands on business analysis & IT project management experience including detailed requirements elicitation. Successful candidate will bring knowledge of configuring, integrating, and migrating Veeva RIM Registrations and Submissions Vaults.
Key responsibilities for this role include:
Provide strong working knowledge of the digital capabilities used to support global regulatory business processes.
Understand regulatory processes and identify regulatory trends and policies that could impact current systems.
Monitor emerging global health authority requirements to assess business and system impact including developing and implementing requirements to ensure compliance.
Collaborate with key business users to identify business needs and translate these needs to user requirements. Translate user requirements into technical requirements and implement solutions to meet requirements.
Provide business analysis techniques including business and functional requirements gathering, process modeling, interviewing, user stories, prototyping, data flows, and root cause analysis.
Successfully manage IT projects for Regulatory Affairs to implementation by coordinating activities of project personnel to ensure the project successfully progresses in scope, on schedule and within budget.
Support project execution tasks to configure, integrate and migrate Veeva RIM Registrations and Submissions Vaults.
Work with teams globally for end-to-end implementation of various R&D systems and ensure compliance with regulations by FDA, EMA and other health agencies.
Drive compliance with IT Quality processes and Viatris SDLC processes, including IT change management and quality/testing procedures.
Collaborate with solutions lead and business partners to ensure technologies are meeting business requirements.
Support the vendor relationship for Regulatory systems, ensuring that system issues are promptly communicated.
The minimum qualifications for this role are:
Bachelor's degree in a science, IT, or a relatable field required. Advanced degrees are a plus. Related experience and education may be considered.
Prior experience in the pharmaceutical industry and a strong understanding of global regulatory business processes.
Experience with validated GxP environments, including Implementation, documentation, and Change Management is necessary.
Hands on experience implementing, configuring and integrating Veeva Vault RIM platform including Registration, Submissions & Archive Vaults. Veeva certification desired.
Broad technical knowledge, including experience with SaaS in a regulated environment.
Subject Matter Expert on technologies and processes related to registration documents, submission records and associated product data records.
Experience in business processes for regulatory such as submission planning and tracking, registration management, commitment management and content management.
Strong business analysis and project management skills as well as attention to detail
Ability to operate in a dynamic challenging environment and manage multiple activities, priorities, and deadlines.
Excellent verbal and written communication skills
Works well in and appreciates the value of a global diverse work environment.
Is able to see the larger picture and able to identify and successfully communicate key issues in complex situations.
This role has remote flexibility. The preference is for the role to be based in Pittsburgh, PA or from a location on the East Coast of the US.
Exact compensation may vary based on skills, experience, and location. The salary range for this position is $78,000 - $152,000.
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.
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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