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At Perrigo, we are driven by our mission to
Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All
. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing
The Best Self-Care for Everyone
, we are the people behind the brands you trust. We are Opill, Compeed, Solpadeine, NiQuitin, ACO, and many more.
We Are Perrigo . We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. Join us on our One Perrigo journey as we evolve to a blended-branded business to win in self-care. Description Overview
In this role, you will manage Regulatory Affairs Projects as required to meet business needs. You will ensure compliance with the existing legislation and regulations for medicines, and assist in any area of Regulatory Affairs at corporate level. Scope of the Role
Lead Regulatory Affairs Projects; providing updates to business and reporting against project plans. Develop regulatory strategies for new MAAs and NPD projects, identifying risks and opportunities. Complete due diligence on time for any assigned product dossiers, identifying risks and opportunities. Manage, execute and co-ordinate new MAA applications/ NPD projects, including product name strategy, product information text, review of claims, advertising material and pack design. Develop, roll out and maintain relevant internal procedures and best practices. Maintain the integrity of regulatory data in the relevant databases. Interpret and implement legislation, follow changes in national regulations and legislations and proactively manage impact of these changes. Experience Required
A scientific degree in a pharmaceutical, chemical or biological discipline. 5 years Regulatory Affairs experience, ideally within UK or EU OTC including Post Marketing Licence Maintenance activities, creation and submission of MAAs. Self-motivated, flexible and open to changing requirements. Highly driven with enthusiasm to meet requirements and cope under demanding pressure. Project management skills and the ability to work autonomously with guidance when required. Ability to make decisions, problem solve, prioritise and multi-task. Continuous improvement and knowledge sharing focused. Benefits We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. Hybrid Working Approach We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles. We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more
here
. Applicants please note:
To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. Our full Equal Employment Opportunity and Affirmative Action Policy Statement is available on our main career site in English and Spanish and will be provided in other accessible forms for persons with disabilities.
#J-18808-Ljbffr
Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All
. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing
The Best Self-Care for Everyone
, we are the people behind the brands you trust. We are Opill, Compeed, Solpadeine, NiQuitin, ACO, and many more.
We Are Perrigo . We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. Join us on our One Perrigo journey as we evolve to a blended-branded business to win in self-care. Description Overview
In this role, you will manage Regulatory Affairs Projects as required to meet business needs. You will ensure compliance with the existing legislation and regulations for medicines, and assist in any area of Regulatory Affairs at corporate level. Scope of the Role
Lead Regulatory Affairs Projects; providing updates to business and reporting against project plans. Develop regulatory strategies for new MAAs and NPD projects, identifying risks and opportunities. Complete due diligence on time for any assigned product dossiers, identifying risks and opportunities. Manage, execute and co-ordinate new MAA applications/ NPD projects, including product name strategy, product information text, review of claims, advertising material and pack design. Develop, roll out and maintain relevant internal procedures and best practices. Maintain the integrity of regulatory data in the relevant databases. Interpret and implement legislation, follow changes in national regulations and legislations and proactively manage impact of these changes. Experience Required
A scientific degree in a pharmaceutical, chemical or biological discipline. 5 years Regulatory Affairs experience, ideally within UK or EU OTC including Post Marketing Licence Maintenance activities, creation and submission of MAAs. Self-motivated, flexible and open to changing requirements. Highly driven with enthusiasm to meet requirements and cope under demanding pressure. Project management skills and the ability to work autonomously with guidance when required. Ability to make decisions, problem solve, prioritise and multi-task. Continuous improvement and knowledge sharing focused. Benefits We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. Hybrid Working Approach We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles. We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more
here
. Applicants please note:
To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. Our full Equal Employment Opportunity and Affirmative Action Policy Statement is available on our main career site in English and Spanish and will be provided in other accessible forms for persons with disabilities.
#J-18808-Ljbffr
