Senior Regulatory Affairs Officer (12 Month FTC)

Benefits

Additional Information

McDermott Laboratories Limited Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making. 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 Obtain and maintain marketing authorisations for products in designated EU territories (internal and 3rd Party / BD). Perform any other regulatory activities as required by company strategy. Every day, we rise to the challenge to make a difference and here's how the Senior Regulatory Affairs Officer role will make an impact: Ensure suitable dossiers (marketing authorisation applications / post-approval submissions) are prepared and dispatched on-time according to agreed company procedures and objectives. Review data intended for submission and advise regarding any deficiencies or issues. Ensure on-time submissions for all safety related changes for assigned projects. Ensure databases and systems (including D2, GLAMS, MyPortfolio and TrackWise) are updated in-line with current SOPs and up-to-date information is available for all assigned products. Ensure SPPs for all assigned projects are maintained in-line with current SOPs and guidance. Liaise with 3rd parties (where required) to establish effective communication and relationships in order to progress regulatory activities. Liaise closely with Business Development (where required), Regulatory Science, Pharmacovigilance, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure alignment in all initiatives. Prepare 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. Advise management of the status and progress of assigned projects 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. Embrace the One Team approach across all Regional Submission Teams by ensuring consolidation of worksharing activities in line with Senior Management guidance, for example increased sharing of expertise and knowledge, combined meetings and collaboration on initiatives and working groups. Support the Line Manager by participating in project teams to support departmental initiatives. Provide mentoring and training to (Associate) Regulatory Officers and/or (Senior) Regulatory Assistants as directed by Line Manager. On an ad hoc basis, carry out additional tasks on behalf of Principal Registration Officer/(Senior) Regulatory Manager. 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: Bachelor's degree or equivalent in Science/Technology/ Pharmacy Experience In Regulatory/Quality/R&D Capable of understanding health authority expectations for pharmaceutical types for a specified region. Strong demonstrable capabilities in the use of software applications. Must possess organization skills, time management skills and attention to detail. 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 Viatris At Viatris, we offer competitive salaries, benefits and an inclusive environmen

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