Manager Corporate Drug Regulatory Affairs (Maternity Cover – ETW)
Company: Viatris (formerly Generics [U.K.] Ltd.)
Viatris empowers people worldwide to live healthier at every stage of life. We advance sustainable operations, innovative solutions, and partnership to improve patient health through a global portfolio of brand‑name products, generics, and other therapeutic offerings.
Role Overview
Manager Corporate Drug Regulatory Affairs responsible for supporting the pharmaceutical regulatory affairs of assigned medicinal products worldwide. The job holder follows instructions from the Team Leader of Corporate Drug Regulatory Affairs.
Key Responsibilities
* Examination, preparation, coordination and processing of regulatory documents, including pharmaceutical quality documentation (CTD – module 3), development, manufacturing, quality control, technology, and pharmacological‑toxicological documentation.
* Responsible for risk‑benefit description for medicinal products with regard to pharmaceutical and pharmacological topics.
* Coordination of clinical and non‑clinical documentation with clinical research, medical information and drug safety.
* Handling marketing authorisation application procedures (new submissions, line extensions, variations) worldwide and registration maintenance activities (variations, renewals).
* Contact with authorities on national and international levels.
* Preparation and discussion of licensing strategies with national and international authorities.
* Provide pharmaceutical‑regulatory support and advice to other departments and business units (e.g., Qualified Person according to German Drug Law).
* Support QA activities (e.g., change control, PQR) and drug information/labeling activities.
* Support pharmacovigilance‑related activities (Risk Management Plans, Company Core Data Sheets, PSURs).
* Training of employees in the CDRA department on pharmaceutical topics.
* Participation in the training and education of pharmacists (e.g., pharmacy students within the third training section according to AAppO).
Skills & Experience
* 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 pharmaceutical and pharmacological know‑how.
* Excellent communication skills and a team‑player mindset.
* Ability to establish working contacts with authorities.
* Excellent English language skills.
* Proficiency in standard EDV programs (e.g., Word, Excel, Powerpoint).
Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. We foster an authentic workplace and encourage applicants whose experience may not fully align with every requirement to apply.
Learn more about our diversity, equity and inclusion efforts: https://www.viatris.com/en/Careers/Diversity-and-Inclusion
Sustainability at Viatris
Corporate social responsibility is fundamental to our mission. To learn more about our efforts, visit: https://www.viatris.com/en/about-us/corporate-responsibility
Viatris is an Equal Opportunity Employer.
Benefits
We offer competitive salaries, benefits and an inclusive environment where you can apply your experiences, perspectives and skills to make an impact on the lives of others.
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