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:
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 Global Regulatory Excellence Process Lead role will make an impact:
Key responsibilities for this role include:
-
Project leadership and strong contribution to regulatory excellence, regulatory process design and optimization.
-
Compiling feedback and provide input to innovative development ideas across the organization and involvement and collaboration with external partners on innovation related developments involving regulatory.
-
Provide guidance and support teams in defining roles and responsibilities and help teams to implement strategies to enhance the capacity and capabilities of those teams, including leveraging collaboration with other regulatory functions.
Process Optimization and Design:
-
Support and sometimes lead the design, development and optimization of processes for the regulatory organization.
-
Work with cross-functional teams responsible for processes involving regulatory responsibility across the organization; provide oversight and alignment on regulatory systems and interdependencies; contribute to communication and training relating to Regulatory process development
-
Establish SME networks and sometimes lead pilots and outcome learnings; Compile ideas from users for system and process improvement; Provide data analytics & metrics helping to identify opportunities for continuous improvement.
Regulatory Process Adherence Oversight:
-
Involve cross functional colleagues and partner on all aspects related to regulatory process adherence oversight
-
Collaboration with Regulatory Policy on training of new regulatory guidelines
-
Collaboration with Regulatory Operations on training of new processes.
-
Contribute in providing oversight on regulatory process design, continuous improvement in frequent newsletter
-
Share awareness of and insight in authorities’ inspections and internal audits of regulatory processes, incl. outcome & findings in the area of responsibility; Support of QE/CAPA related activities for regulatory and cross-functional alignment.
-
Utilize data analytics to provide an understanding of data flow and trends leading to identification of process improvements.
The minimum qualifications for this role are:
-
Bachelors degree is required. Masters degree is preferred.
-
Previous experience in a Regulatory function required.
-
Previous experience in process design and project management preferred.
-
Compliance background preferred.
-
Comprehensive knowledge of departmental and organizational policies and procedures.
-
5+ years understanding of global/regional regulatory & safety perspectives.
-
3+ years Ability to work in multi-national / multi-cultural teams and cross-functional teams and sometimes lead those teams.
-
3+ years Strong experience in drug development, quality, drug safety/PV/risk management.
-
Passionate about process design and project management with influential skills.
-
Proven ability to consistently deliver to time, cost and quality standards.
-
Collaborative team player with excellent interpersonal and strategic influencing and cross-functional working skills.
-
Willingness to travel.
-
Experienced in information technology systems, strong focus on regulatory systems and passion for digitalization & innovation.
-
Proficiency in speaking, comprehending, reading and writing English is required.
Exact compensation may vary based on skills, experience, and location. The salary range for this position is $96,000 - $187,000.
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.
#Li-Remote
Please Note :
caminobluff.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, caminobluff.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.