Senior Specialist Regulatory Operations (Electronic Submissions)

1100 Mylan Pharmaceuticals Inc.; Dublin; On-site; EUR 70,000 - 110,000; Full time

Benefits offered by this job

Compensación competitiva

Seguro médico 100% pagado

Plan de pensiones con contribución del empleador

Días de voluntariado pagados

Job summary

Una empresa farmacéutica global busca un Especialista Senior en Presentaciones Electrónicas para gestionar las presentaciones regulatorias de manera eficiente y cumplir con los estándares de la empresa. El candidato ideal tendrá un enfoque en la calidad del trabajo y conocimientos críticos en operaciones regulatorias. Este rol incluye la gestión de los cronogramas de publicación y la formación de colegas más jóvenes. Se ofrece un paquete de compensación competitivo con beneficios atractivos, que garantiza el bienestar de los empleados.

Qualifications

• Título universitario en Gestión de la Información, Ciencias Biológicas, Administración de Empresas o equivalente.
• Conocimiento profundo en el sector de operaciones regulatorias, especialmente en gestión de publicaciones y presentación de documentos.
• Conocimiento experto de los requisitos de eCTD para múltiples autoridades de salud.
• Experience with MS Office, Adobe Acrobat Pro, DMS, eCTD publishing software and registration systems.
• Excellent English communication and ability to multi-task in a fast-paced environment.

Responsibilities

• Apoyar la publicación y presentación de documentos regulatorios en formato electrónico.
• Realizar control de calidad y validación técnica de las presentaciones electrónicas.
• Servir como contacto principal y experto en consultas sobre publicaciones.
• Serve as SME for publishing queries across Regulatory Affairs and cross-functional disciplines.
• Develop and maintain regulatory system guidelines and training materials.
• Mentor junior colleagues in publishing practices and software usage.
• Act as backup for management in their absence.

Skills

Regulatory operations

Publishing expertise

eCTD knowledge

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree or equivalent

Tools

MS Office

Adobe Acrobat Pro

Document Management Systems

eCTD publishing software

Regulatory submissions systems

Job description

Senior Specialist Electronic Submissions page is loaded## Senior Specialist Electronic Submissionslocations: Northern Cross, Dublin, Irelandtime type: Tiempo completoposted on: Publicado hoyjob requisition id: R5665456McDermott Laboratories LimitedEn VIATRIS, vemos la atención médica no como es, sino como debería de ser. Actuamos con valentía y estamos en una posición única para ser una fuente de estabilidad en un mundo de necesidades de atención médica en constante evolución.Viatris ayuda a las personas de todo el mundo a vivir de manera más saludable en cada etapa de la vida.Lo hacemos a través de:Acceso – suministrando medicamentos de confianza y de alta calidad independientemente de la geografía o las circunstancias;Liderazgo – promoviendo operaciones sostenibles y soluciones innovadoras para mejorar la salud del paciente;Colaboración – aprovechando nuestra experiencia común para conectar a las personas con productos y servicios.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**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 visitEn Viatris, ofrecemos salarios competitivos, beneficios y un entorno inclusivo donde puede usar sus experiencias, perspectivas y habilidades para ayudar a generar un impacto en la vida de los demás.Viatris es una compañía global del cuidado de la salud creada en 2020 a través de la combinación de Mylan y Upjohn, una división legada de Pfizer. Al integrar las fortalezas de estas dos compañías, incluida nuestra fuerza laboral global de aprox. 45,000, nuestro objetivo es proporcionar acceso mejorado a medicamentos de calidad asequibles a pacientes de todo el mundo, independientemente de dónde vivan o de las circunstancias. Creemos en el cuidado de la salud como debe ser: empoderamos a las personas de todo el mundo para que vivan de manera más saludable en cada etapa de la vida. Debido a nuestra creencia firme de que un acceso mejorado permite una mejor salud, aprovechamos nuestra experiencia científica y de manufactura inmejorable, al igual que las capacidades comerciales comprobadas, para ofrecer a los pacientes medicamentos de calidad en el momento y en el lugar que los necesiten.