Generics [U.K.] Ltd.

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

Manager Corporate Drug Regulatory Affairs responsible to support the pharmaceutical-regulatory of the assigned medicinal products and products worldwide. The jobholder is bound to the instructions of the responsible Team leader of Corporate Drug Regulatory Affairs.

Key Responsibilities

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

Examination, preparation,coordination and processing of regulatory documents, pharmaceutical quality documentation (CTD – module 3), pharmaceutical development, manufacturing and quality control, pharmaceutical technology, pharmacological-toxicological documentation, as well as pharmaceutical expert reports,

Responsible for Risk-benefit-description for medicinal products with regard to pharmaceutical-pharmacological topics,
Coordination of clinical and non-clinical documentation with clinical research, medical information and drug safety,
Handling of marketing authorisation application procedures (new submissions, line extensions, variations) worldwide, as well as registration maintenance activities (eg variations, renewals),
Contact to authorites on national and international level,
Preparation and discussion of licensing strategies with national and international authorities,
Pharmaceutical-regulatory support and advice to other departments and business units (e.g.. of the Qualified Person acc. § 15 German Drug law) regarding pharmaceutical topics before / during / after approval at national and international level,
Support of QA activities (e.g. change control, PQR) and support of drug information/ labelling acitivies,
Support of pharmacovigilance related activities (e.g. Risk Management Plans, Company Core Data Sheets, PSURs),
Training of employees of the CDRA department with regard to pharmaceutical topics

Participation in the training and education of pharmacists (e.g. pharmacy students in the context of the third training section according to AAppO)

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:

Completed university degree in pharmacy, according to the approbation regulations for pharmacists (AAppO)).
Experience in regulatory affairs,
Knowledge of essential regulatory requirements globally,
Ability to plan and execute regulatory projects with special consideration of the pharmaceutical and pharmacological know-how,
Excellent communication skills, a real team player,
Ability to establish working contacts with authorities
Excellent skills in English language,
Knowledge in standard EDV programs (e.g. Word, Exel, Powerpoint).

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.

Manager Corporate Drug Regulatory Affairs (Maternity Cover – ETW)

Job Description