Senior Regulatory Affairs Administrator - Central Regulatory Affairs (CRA)

Posted 4 Days Ago
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Lisbon, PRT
In-Office
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
Supports European pharmaceutical regulatory activities, including post-approval variations, renewals, notifications, marketing authorization maintenance, regulatory database updates, fee processing, purchase orders, and coordination with affiliate and cross-functional teams. The role requires strong organization, attention to detail, communication, and an interest in pharmaceutical Regulatory Affairs.
Summary Generated by Built In
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 Story

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.


Viatris empowers people worldwide to live healthier at every stage of life.


We do so via:


  • Access – Providing high quality trusted medicines regardless of geography or circumstance;
  • Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
  • Partnership – Leveraging our collective expertise to connect people to products and services.

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

This is an excellent opportunity for an organised and detail-oriented professional looking to develop a career in Regulatory Affairs within the pharmaceutical industry.

You will support regulatory activities across Europe, helping to ensure medicinal products remain compliant with European and local regulatory requirements while working closely with internal stakeholders and affiliate teams.


Every day, we rise to the challenge to make a difference, and here’s how the (Senior) Regulatory Affairs Administrator - Central Regulatory Affairs (CRA), Europe role will make an impact:


Key responsibilities for this role include:

  • Support regulatory activities across a portfolio of pharmaceutical products throughout Europe.
  • Assist with post-approval submissions including variations, renewals, and regulatory notifications.
  • Coordinate administrative and compliance activities to support the maintenance of marketing authorisations.
  • Maintain and update Regulatory Information Management (RIM) systems and databases.
  • Work closely with local affiliate teams on regulatory and operational activities.
  • Support regulatory fee processing, purchase orders, and other administrative tasks.
  • Collaborate with cross-functional teams to ensure timely delivery of regulatory objectives
  • undefinedAbout Your Skills & ExperienceFor this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences: Previous administrative experience, ideally within pharmaceuticals, healthcare, life sciences, or a regulated environment.A strong interest in Regulatory Affairs and the pharmaceutical industry.Excellent organisational skills and attention to detail.Strong communication and stakeholder management skills.Fluent English, both written and spoken.Regulatory Affairs experience is advantageous but not essential. 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. 

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.

Skills Required

  • Previous administrative experience
  • Experience in pharmaceuticals, healthcare, life sciences, or another regulated environment
  • Strong interest in Regulatory Affairs and the pharmaceutical industry
  • Excellent organizational skills and attention to detail
  • Strong communication and stakeholder management skills
  • Fluent English, written and spoken
  • Regulatory Affairs experience

Viatris Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Viatris and has not been reviewed or approved by Viatris.

  • Fair & Transparent Compensation — Compensation is frequently characterized as competitive and fair for the role, with “good pay” and “fair pay for job” appearing alongside references to competitive salary. This is reinforced by mentions of annual bonuses and overall satisfaction with pay levels in many roles and locations.
  • Healthcare Strength — Health coverage is portrayed as comprehensive, including private health insurance in some regions and broad medical support options. Mental health support is also emphasized through EAP access and coaching resources as part of the broader health offering.
  • Retirement Support — Retirement benefits appear robust, with references to defined contribution pension arrangements and a 401(k) with employer matching, plus options for different contribution types. Profit-sharing and long-service/loyalty awards further support longer-term financial value.

Viatris Insights

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The Company
HQ: Pittsburgh, PA
16,557 Employees
Year Founded: 2020

What We Do

Viatris is a global pharmaceutical company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer.

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