Overview
Join to apply for the Regulatory Affairs Senior Specialist role at Viatris. Viatris is dedicated to helping create healthier communities worldwide and fostering a collaborative culture that encourages courage and resilience.
The Role & What You Will Be Doing
* Life cycle management and regulatory filing maintenance activities, including preparation, review and submission of FDA required Annual Reports for (Abbreviated) New Drug Applications: scheduling and coordinating documentation, preparing cover letters, describing changes, and tracking progress; reviewing documents and using the change control system to ensure accurate reporting; ensuring compliance with product licences.
* Preparation, review and submission of amendments and supplements/variations to product marketing applications.
* Provide regulatory guidance to other departments (QA, QC, Manufacturing, etc.) for planned changes.
* New Product Submission Activities: preparation of submission documentation in eCTD format for pharmaceutical products (including combination products) for approval by US FDA, European Regulatory Authorities and worldwide; monitor progress of regulatory submissions, respond to queries and help ensure timely approvals; conduct critical, detailed reviews of technical documentation prior to submission.
* Assess change control documentation and recommend the appropriate regulatory reporting mechanism using Health Authority regulations, guidance documents and in-house policies; submit associated amendments/variations/supplements as required.
* Establish and maintain positive working relationships with internal and external partners to facilitate efficient regulatory goals; actively participate in project teams; research information pertaining to regulatory documentation; maintain current knowledge of applicable regulations and guidances.
About Your Skills & Experience
* Strong knowledge of the Regional Pharmacopoeia (Ph. Eur. & USP), Title 21 of the CFR, and Health Authority Guidance for Industry (especially sterile products).
* Knowledge of the regulatory process relating to drug development, registration, review and approval.
* Knowledge of parenteral product submissions.
* Experience in writing and submitting regulatory documentation.
* Knowledge of cGMP awareness and compliance.
* Knowledge of sterile products and their unique regulatory requirements.
* Excellent communication skills, both oral and written.
* Ability to respond quickly to a changing regulatory environment.
* Computer skills: Outlook, Microsoft Word, Excel, PowerPoint, change management systems, and documentation management systems.
Viatris is an equal opportunity employer. We encourage candidates with diverse backgrounds to apply.
Benefits & Company Information
At Viatris, we offer competitive salaries and benefits and an inclusive environment where you can contribute your experiences, perspectives and skills to help improve lives. Benefits include career progression opportunities, work-life balance initiatives, bonus schemes, health insurance, and pension.
Diversity & Inclusion
Diversity and inclusion are essential to Viatris’ mission. To learn more about our approach, visit Viatris careers pages related to diversity and inclusion.
Sustainability
Corporate social responsibility is fundamental to Viatris, and we work to advance responsible and sustainable operations across the company.
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