Senior Manager Regulatory Operations

<p>Perrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold.  Help us do it.</p> <p><br/> External applicants please note:  To <u>apply</u> to this position please click the <u>APPLY</u> 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.</p> <h2>Description Overview</h2> <p> </p> <p>Within the Consumer Self-Care International business unit (main focus on Europe), lead the growing and evolving Regulatory Affairs Operations team responsible for centralised Regulatory systems &amp; processes and Regulatory data management &amp; compliance.</p> <h2>Scope of the Role</h2> <p> </p> <p>The main objectives of the job are</p> <ul> <li>To be the main contact/representative for Regulatory Affairs (RA) in business initiatives/projects involving or impacting data, systems and processes (Enterprise Content Management, Product Lifecycle Maintenance, Change Control)</li> <li>To drive business initiatives/projects involving or impacting RA data, systems and processes (Regulatory Information Management system, eCTD publishing system)</li> <li>To ensure RA data compliance with external requirements (main focus on Europe (SPOR, PLM)), through adequate processes and systems </li> <li>To ensure RA data are current, accurate, usable and adequately linked to the relevant systems and processes in place in the business</li> <li>To ensure appropriate support and training are in place for the relevant RA community concerning the systems and processes in use in the business</li> <li>To drive optimisation of the systems and processes in use in the business;</li> <li>To create and maintain processes that enable centralised medicinal publishing within the business unit (EU) with a view to expand those processes to the wider RA Community. </li> <li>To support equipping the Regulatory Affairs function for further digital transformation including integration of data and Artificial Intelligence solutions</li> <li>To manage a team of Operations Administrators (currently two team members but with planned future expansion)</li> </ul> <h2>Experience Required</h2> <p> </p> <ul> <li>Bachelor or Master’s degree in Life Science or Information Technology </li> <li>8 years of experience in a relevant regulatory environment ideally part of it within an Operations role </li> <li>Great communication skills. </li> <li>Good project management skills.</li> <li>‘Give it a go’ and positive attitude being keen on creative and problem-solving thinking whilst being thorough and focused with attention to detail. </li> <li>The ability to support several concurrent projects/products in a flexible manner both autonomously and in a team environment. </li> <li>Must be collaborative and able to influence change. </li> <li>Inclusive and customer service oriented. </li> </ul> <p>External applicants please note:  To <u>apply</u> to this position please click the <u>APPLY</u> 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.</p> <p><em>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 <u>English</u> and <u>Spanish</u> and will be provided in other accessible forms for persons with disabilities.</em> #DIV</p>