Senior Specialist Regulatory Operations (Electronic Submissions)

Viatris; Lisboa; On-site; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Top Employer Accreditation

Competitive compensation package

Health & Wellness programmes

100% paid medical insurance

Life cover

Employer-matched pension (11%)

2 paid volunteer days

Job summary

Viatris seeks a Senior Specialist, Electronic Submissions to support end-to-end publishing and submission of regulatory dossiers for new and existing products. You will ensure quality control, electronic transmission, and archiving, while mentoring junior colleagues and leading publishing activities.

This international role requires strong English communication, expertise in eCTD, and the ability to coordinate with Regulatory Affairs and cross-functional teams.

Qualifications

• Bachelor’s degree with focus on Information Management, Bio Science, Business Administration or equivalent preferred.
• Profound knowledge in regulatory operations, especially publishing and dossier submission management.
• Expert knowledge of eCTD requirements for multiple Health Authorities.
• Proficiency with MS Office, Adobe Acrobat Pro, DMS, eCTD publishing software and related systems.
• Excellent written and spoken English.

Responsibilities

• Publish, transmit, and archive MA applications and maintenance submissions in eCTD or non-eCTD formats, to meet deadlines and SLAs.
• Perform QC and technical validation of electronic submissions.
• Manage and monitor publishing schedules; provide workload summaries.
• Serve as SME for publishing queries across Regulatory Affairs and cross-functional teams.
• Contribute to creation, maintenance, and training of internal system guidelines.

Skills

English (written and spoken)

Multi-tasking

Independent and proactive

Results-oriented

Education

Bachelor’s degree (Information Management/Bio Science/Business Admin)

Tools

MS Office

Adobe Acrobat Pro

DMS

eCTD Publishing software

Registrations management systems

Job description

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 quickly learn new technology.

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

Benefits At Viatris

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. Some of our benefits include the following on top of a competitive salary:

• Top Employer Accreditation, demonstrating that we provide excellent people policies and practices.
• Competitive compensation package.
• Focus on career progression with growth and development opportunities.
• Emphasis on Health & Wellness programmes.
• 100% paid medical insurance and Employee Assistance Programme.
• Life cover.
• Excellent employer-matched pension scheme with Viatris contributing up to 11%.
• 2 paid volunteer days per year.

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

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.