Senior Specialist Regulatory Operations (Electronic Submissions)

1100 Mylan Pharmaceuticals Inc.; Lisboa; Presencial; EUR 42 000 - 66 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical insurance

Pension scheme

Volunteer days

Career progression

Resumo da oferta

Viatris in Lisbon, Portugal, seeks a Senior Specialist Regulatory Operations (Electronic Submissions) to support end-to-end publishing and submission of regulatory dossiers in electronic format. The role requires coordination with global teams and adherence to timelines.

With minimal supervision, you will manage eCTD submissions, perform QC, maintain publishing schedules, and mentor junior colleagues while acting as SME across Regulatory Affairs and related functions.

Qualificações

• Bachelor's degree with focus on Information Management, Bio Science, Business Administration or equivalent preferred.
• Profound knowledge in the regulatory operations sector, especially in publishing and dossier submission management.
• Must maintain expert knowledge of eCTD requirements for multiple Health Authorities.
• Expertise with MS Office, Adobe Acrobat Pro, Document Management Systems (DMS), eCTD Publishing software and registrations management systems and related regulations.
• Very good command of written and spoken English.

Responsabilidades

• Publish, transmit, and archive MA Applications and maintenance submissions in eCTD or non-eCTD formats.
• Perform QC and technical validation of electronic submissions.
• Manage and monitor publishing schedules and coordinate global support.

Conhecimentos

Regulatory operations knowledge

eCTD knowledge

English proficiency

Multi-tasking

Cross-functional collaboration

Mentoring

Formação académica

Bachelor's degree (Information Management / Bio Science / Business Administration)

Ferramentas

MS Office

Adobe Acrobat Pro

Document Management Systems

eCTD Publishing software

Regulatory systems

Descrição da oferta de emprego

Senior Specialist Regulatory Operations (Electronic Submissions)Postuler:

Lisbon, Lisbon, Portugal:

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.

• 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.
• 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.
• 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.

Ability to work in a fast paced environment. Must possess excellent attention to detail and propensity to learn.

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.

• 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

Senior Specialist Regulatory Operations (Electronic Submissions) Lisbon, Portuguese Republic, PT