Alexion Dublin Ireland
2 months ago
Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
This is a Fixed Term Contract for 12 – 18 months
This is what you will do:
The Regulatory Affairs Senior Manager works under the responsibility of the Local Regulatory Affairs Lead, to ensure regulatory compliance of Alexion’s local product portfolio with all applicable pharmaceutical regulations in accordance with the company's specifications and the applicable relevant, processes, and standards.
The Regulatory Affairs Senior Manager supports the RA Team in interactions... with the HPRA, MMA and MHRA.
You will be responsible for:
• Ensure timely submission and approvals of all registration relevant activities for assigned products compliance with UK/IE/MT regulatory requirements where applicable, including maintenance of such registrations in ARISE,
• Ensure timely submission of pre-registration applications in compliance with UK/IE/MT regulatory requirements where applicable,
• Collaborate with Global Regulatory Affairs Leads (GRL’s) for assigned products, including paediatric submissions to the MHRA,
• Manage update of pack changes and ensure labelling compliance,
• Provide regulatory input to stock and supply issues,
• Develop and maintain an effective professional working relationship with assessors and administrative staff within the regulatory agencies,
• Coordinate the revision and distribution of additional Risk Minimization Measures (aRMMs), such as educational materials to the HPRA & MHRA and obtain timely HA approval,
• Liaise with the Patient Supply Group (PSG) with regards to controlled distribution requirements i.e. patient approval and product switches in SAP,
• Collaborate with the Local Safety Officer (LSO) or the delegate regarding tracking and implementation of local additional Risk Minimization Measures (aRMMs),
• Collaborate with Country Quality to ensure compliance with Alexion’s quality management system (QMS), including support MHRA inspections, internal audits and risk assessments,
• Support the New Product Team (NPPT) for assigned pipeline projects where and if required,
• Actively contribute in regional cross functional GxP forum,
• Line management responsibilities if applicable
You will need to have:
• Minimum of 5 years of experience in Regulatory Affairs within the pharmaceutical industry
• Pharmacist or equivalent education in a life science discipline (biology, chemistry, etc.)
• Hands-on operational working experience with all types of regulatory submissions to Competent Authorities including general life product cycle maintenance
• Ability to pro-actively build team relationship and collaborate in a matrix environment
• Good English, oral and written communication skills are required
• Ability to support ad hoc projects including working in small to medium sized project teams
• Ability to work in a highly agile and flexible environment
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact [email protected]. Alexion participates in E-Verify.
AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here
Senior Manager, Regulatory Affairs - UK, Ireland and Malta Dublin jobs
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