Senior Specialist Regulatory Operations (Electronic Submissions)

Mylan, Lda. Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

With minimal supervision, support the end-to-end publishing and submission of regulatory dossiers for new and existing products in electronic format to meet company standards, agency requirements and defined timelines. This includes quality control, validation, electronic transmission, and archiving of submissions. Utilise specialised publishing, document management and RIM tools as appropriate. Troubleshoot technical issues, manage submission schedules, and serve as a subject matter expert for publishing activities. Contribute to process improvements, system support, and regulatory project work, while also mentoring junior colleagues and providing leadership support as needed.

Every day, we rise to the challenge to make a difference and here’s how the Senior Specialist, Electronic Submissions role will make an impact:

• Publish, transmit, and archive Marketing (MA) Applications and maintenance submissions in eCTD or non-eCTD formats as appropriate, for new and existing products, in a timely manner to meet deadlines and Service Level Agreements.
• Perform QC and technical validation of electronic submissions to ensure compliance with internal standards and external criteria before delivery to the Regulatory Users for internal review/approval.
• Manage and monitor publishing schedules, coordinate global support during resource constraints, and provide workload and project summaries at team meetings or to leadership
• Serve as the primary contact and Subject Matter Expert (SME) for publishing queries across Regulatory Affairs and cross-functional disciplines.
• Contribute to the creation, maintenance, and training of internal regulatory system guidelines within scope of this role.
• Develop and maintain an advanced working knowledge of publishing software and other regulatory systems within scope of this role
• Mentor junior colleagues in publishing practices, workload management and software system use
• Act as a backup for management in their absence, including coordination of workload for the team, meeting attendance and answering queries

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

Bachelor’s degree with focus on Information Management, Bio Science, Business Administration or equivalent preferred. However, a combination of experience and/or education will be taken into consideration.

• Profound knowledge in the regulatory operations sector, especially in publishing and dossier submission management or related areas.
• Must maintain expert knowledge of eCTD requirements for multiple Health Authorities
• Expertise with MS Office, Adobe Acrobat Professional, Document Management Systems (DMS), eCTD Publishing software and registrations management systems and associated global publishing processes and related regulations.
• Due to the international nature of this position, you have a very good command of written and spoken English.
• Must possess ability to multi-task and manage multiple projects and deadlines.
• Ability to work in a fast paced environment.
• Must possess excellent attention to detail and propensity to learn.

Personally, you are characterised by your independent, proactive, and results-oriented work style and your ability to collaborate in cross-functional teams and a demonstrated ability to