Senior Specialist Regulatory Operations (Electronic Submissions)

1100 Mylan Pharmaceuticals Inc.; Lisboa; Híbrido; EUR 42 000 - 62 000; Tempo integral

Resumo da oferta

Viatris is seeking a Senior Specialist, Regulatory Operations (Electronic Submissions) in Lisbon to manage end-to-end publishing and submission of regulatory dossiers in electronic formats. You will ensure QC, validate submissions, and oversee schedules with global coordination.

The role requires expertise in eCTD, DMS systems, and publishing software, plus strong English skills and the ability to work in a fast-paced, cross-functional environment.

Qualificações

• Bachelor’s degree or equivalent in Information Management, Bio Science, or Business Admin.
• Expert knowledge of regulatory publishing and dossier submission processes.
• Strong command of eCTD requirements across Health Authorities.
• Experience with DMS, MS Office, Adobe Acrobat, and eCTD tools.
• Excellent English, detail-oriented, and able to manage multiple projects.

Responsabilidades

• Publish, transmit, and archive regulatory submissions in eCTD or non-eCTD formats.
• Perform QC and technical validation of submissions before internal review.
• Manage global publishing schedules and team workload.
• Serve as SME for publishing queries across Regulatory Affairs.
• Develop and maintain internal guidelines and training materials.
• Mentor junior colleagues in publishing practices and software use.
• Act as backup for management and coordinate team workload.

Conhecimentos

Regulatory operations

eCTD knowledge

Publishing software

Project management

English proficiency

Formação académica

Bachelor’s degree or equivalent

Ferramentas

MS Office

Adobe Acrobat Pro

DMS

eCTD publishing software

Descrição da oferta de emprego

## Senior Specialist Regulatory Operations (Electronic Submissions)Postuler: Lisbon, Lisbon, Portugal: Temps plein: Offre publiée aujourd'hui: R5665456Mylan, Lda.Viatris est une entreprise mondiale de la santé idéalement placée pour combler la division traditionnelle entre génériques et marques, combinant le meilleur des deux pour répondre de manière plus globale aux besoins de santé à l'échelle mondiale. Avec pour mission d'autonomiser les personnes du monde entier pour vivre en meilleure santé à chaque étape de la vie, nous offrons un accès à grande échelle, fournissant actuellement des médicaments de haute qualité à environ 1 milliard de patients dans le monde chaque année et touchant tous les moments de la vie, de la naissance à la fin de vie, des affections aiguës aux maladies chroniques. Nous avons été inclus dans plusieurs listes de récompenses qui démontrent l'impact que nous avons.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