McDermott Laboratories Limited

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

The RA Manager role is responsible for providing Regulatory direction for assigned product(s), assisting in development and implementation of regulatory strategy that aligns with business needs, maintaining relations with strategic partners through to stakeholders, providing regulatory advice to other business functions, as well as Local Regulatory Teams.

Key Responsibilities

Every day, we rise to the challenge to make a difference and here’s how the RA Manager role will make an impact:

Deputise for Senior Regulatory Manager/ Director, where directed. Where required, manage a and develop a team (including performance review and talent development).
Actively involved in the 'One Team' approach across all Regional Regulatory Teams through active participation and collaboration on combined team meetings, initiatives and working groups.
Where required, manage a team to ensure suitable dossiers/ submission components are prepared and dispatched on-time for internal developments and 3rd Party / BD projects according to agreed company procedures and objectives. Support team members by advising/ escalating to Line Manager any deficiencies or issues.
Partner with Local Regulatory teams to ensure timely submission and effective interactions with Health Authorities.
Ensure Regulatory Information Management systems and other internally required systems/ databases are actively maintained by self and direct reports in-line with current SOP/ Work Instructions and agreed timelines; ensuring up-to-date information is available for all team projects.
Liaise with 3rd Parties/ Business Development (BD) Partners, establish effective communication channels and build positive relationships in order to progress regulatory activities.
Prepare regulatory strategies for new Marketing Authorisation Applications (MAA). When required, present new MAA strategies to Leadership team at Submission Strategy Meetings.
Review and agree regulatory strategies for post-approval submissions in collaboration with Regulatory Science, incorporating region specific requirements.
Support team members with preparation/ review of regulatory strategies (including advising of the regulatory requirements) for new marketing authorisation applications / post-approval submissions.
Be actively involved in due diligence activities including evaluation of regulatory strategy and launch timelines, evaluation of risks and regulatory costs.
Support the Regional Regulatory Teams by participating in working groups/ project teams to support or develop strategies for departmental initiatives and ensure the successful roll-out of regional or global initiatives, including the creation, update and review of SOPs/ Work Instructions.
Advise Senior Management of the status and progress of assigned projects to meet departmental/regional objectives and timelines, identifying potential problems or delays, and possible solutions, as they occur; and maintain a current status report for these projects.
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.

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 in Life sciences or related area. A higher degree (Msc or PhD would be advantageous)

Extensive and proven experience in Regulatory Affairs.

Effective verbal and written communication skills.

Proven experience in managing large volume and fast paced product portfolios.

Flexible approach to enable prioritisation in line with company requirements.

Previous experience in mentoring junior team members.

Proven ability to effectively participate in working groups or 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 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 https://www.viatris.com/en/Careers/Diversity-and-Inclusion

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 visit https://www.viatris.com/en/about-us/corporate-responsibility

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.

Regulatory Affairs Manager (Maternity Cover – ETW)

Job Description