Regulatory Affairs Senior Specialist

Mylan TeorantaAt 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; andPartnership – 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 DoingEvery day, we rise to the challenge to make a difference and here's how theRegulatory Affairs Senior Specialistrole will make an impact:Life cycle management and regulatory filing maintenance activities;Preparation, review and submission of FDA required Annual Reports for (Abbreviated) New Drug Applications including scheduling and coordinating receipt of documentation/information, preparing cover letters, describing changes made to the application, and tracking progress of their preparation.This also includes the review of documents, and utilizing the change control database to ensure accurate reporting and tracking FDA acknowledgements.Failure to prepare accurate and timely Annual Reports could result in FDA action which may include the removal of products from the marketplace.Assess and review documentation to ensure compliance with product licences.Preparation, review and submission of amendments and supplements/variations to product marketing applications.Provide departmental management regulatory guidance and input 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 the US FDA, European Regulatory Authorities and worldwide, as required.Monitoring the progress of regulatory submissions, responding to queries and ensuring that approvals are granted without undue delays.Provide a critical detailed review of technical documentation, including but not limited to, analytical procedures, validation/verification reports, product specifications, manufacturing batch records, in-process specifications, drug substance information, device related information etc. prior to submission.Assessment of change control documentation and recommend the appropriate regulatory reporting mechanism using Health Authority regulations, guidance documents and in-house policies and submit associated amendments / variations / supplements as required.Establish and maintain positive working relationships with internal and external partners to facilitate efficient accomplishment of regulatory goals.Actively participate in project teams, as required.Research information pertaining to marketing applications through the navigation of existing submissions and associated comments and regulatory documentation system.Maintain current knowledge of regulations and guidances as applicable to role by utilizing the Health Authority websites and attendance at conferences.About Your Skills & ExperienceFor this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences:Strong knowledge of the Regional Pharmacopoeia (Ph. Eur. & USP), Title 21 of the Code of Federal Regulations and various Health Authority Guidances for Industry (particularly those dealing with sterile products).Knowledge of the regulatory process pertaining 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.Experience in writing and submitting regulatory documentation.Ability to respond quickly to a changing regulatory environment.Computer skills, E-mail (Outlook), Microsoft Word, Excel, Powerpoint, change management systems and documentation management systems an advantage.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.Benefits At ViatrisAt 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.Some of our benefits include the following on top of a competitive salary:Excellent career progression opportunitiesWork-life balance initiativesBonus schemeHealth insurancePensionDiversity & Inclusion at ViatrisAt 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 visitSustainability at ViatrisCorporate 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.