Regulatory Affairs Executive (12 months agency contract)

Viatris Inc.; Dublin; On-site; EUR 50,000 - 70,000; Full time

Job summary

A leading global healthcare company in Dublin is seeking a Regulatory Affairs Executive to manage regulatory activities for post-approval submissions. This role involves coordinating submissions, ensuring compliance, and liaising with various stakeholders. The ideal candidate will have a BSc in Life Sciences, experience in Regulatory Affairs, and excellent communication skills. Join us to help improve patient health and make a difference in the world.

Benefits

Competitive salary

Inclusive work environment

Career development opportunities

Qualifications

• Bachelor's degree in Life Sciences or a related field.
• Experience in Regulatory Affairs is mandatory.
• Strong verbal and written communication skills.

Responsibilities

• Coordinate Regulatory activities for post-approval submissions.
• Prepare and dispatch post-approval submissions on time.
• Advise management of project status and potential issues.

Skills

Demonstrable experience in Regulatory Affairs

Excellent communication skills

Attention to detail

Ability to manage a large product portfolio

Proficiency in Microsoft Office Suite

Education

BSc or equivalent in Life Sciences

Tools

Documentum-based applications

Job description

**Cookie Notice**Viatris UK HealthcareAt 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 role will support the management and coordination of regulatory activities to support special projects in accordance with departmental objectives and regional and global regulatory strategy.Every day, we rise to the challenge to make a difference and here’s how the Regulatory Affairs Executive role will make an impact:* Coordinate Regulatory activities for post-approval submissions, particularly with respect to labelling changes, and prepare supporting documentation.* Ensure suitable post-approval submissions are prepared and dispatched on-time according to agreed company procedures and objectives. Review data intended for submission and advise regarding any deficiencies or issues.* Devise regulatory strategies (including advising of the regulatory requirements) for post-approval submissions with support from Line Manager.* Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities) and use this information to optimise departmental procedures and processes and to ensure Health Authority requirements and Regulatory Compliance are maintained.* Liaise closely with Artwork, Supply Chain, Quality, Regulatory and other stakeholders to ensure alignment in all initiatives.* Liaise with 3rd parties (where required) to establish effective communication and relationships in order to progress regulatory activities.* Advise management of the status and progress of assigned projects identifying potential problems or delays, and possible solutions, as they occur and maintain a current status report for these projects.* Keep databases and systems updated in-line with current SOPs so that up-to-date information is available.* Use and update all appropriate company tracking tools in accordance with specified working processes.* Maintain product information and artwork within the correct system, to reflect current registered versions.* Ensure the eMC database is updated with any changes to approved SmPCs and PILs.* Create and maintain Abbreviated Prescribing Information, as requested, to support Marketing team activities.**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:* BSc or equivalent in Life Sciences or related area.* Demonstrable experience in Regulatory Affairs.* Excellent communication skills, both verbal and written.* Proven experience in managing a large volume and fast paced product portfolio.* Excellent attention to detail.* Flexible approach to enable prioritisation in line with company requirements.* Proven ability to effectively participate in working groups or cross functional project teams, and successfully collaborate with colleagues.* Computer literacy with Microsoft Office Suite and Documentum-based applications.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.**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 visitAt 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.