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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 What You Will Do

The Regulatory Affairs Manager (RAM) is a regulatory professional who will:
• In collaboration with the Regulatory Affairs Marketed Products (RAMP) Global Regulatory Leads (GRLs), be responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables to support life cycle management and international expansion.
• Lead simple through more complex regulatory applications and managing procedures through... approval for Alexion products globally.
• Provide regulatory expertise and guidance on procedural and documentation requirements to the Regulatory Sub-Team (RST) and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
• Contribute to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory documents’ preparation and development of response to Health Authorities questions, working in close collaboration with global regulatory lead and cross-functional colleagues.
• Participate in the development of processes and procedures relevant to the submissions.
• Support for communications to responsible Regulatory Agency personnel in regard to submissions after discussion with regulatory lead if appropriate.

You Will Be Responsible For
• Understanding the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• Providing regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:
• * Submission delivery strategy of all dossiers and all application types per market and /or region.
• Review of documents (e.g. response documents, study protocols, PSRs, etc.).
• Analysis of regulatory procedures and special designations used during development, authorizations, and extension of the product.
• Providing regulatory expertise on procedural and documentation requirements to GRL, country RQA Directors and other functions for assigned deliverable(s) including:
• Technical content of submission dossiers
• Procedural and documentation requirements for document reviews (e.g., study protocols, PSRs, response documents etc.)
• Interpretation of regulatory data, regional trends, critical regulatory requirements, policies and procedures as well as identifying opportunities for accelerated development and/or early submission and approval in assigned region.
• Using and sharing best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.
• Leading and / or contributing to the planning, preparation (including authoring where relevant) and delivery of simple and with experience, increasingly more complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
• Developing, executing, and maintaining submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Coordinating the input, maintenance and revision in the Planit project plans for assigned projects and highlight unforeseen changes in resource demand in a timely manner to Lead RPM, if any, and line manager.
• Identifying regulatory risks and propose mitigations to Lead RPM and cross functional teams.
• Supporting operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing the support and input of Regulatory Operations, MCs, CROs and/or alliance partners where relevant.
• Project managing assigned deliverables which include but are not limited to new drug applications/biologics license application/marketing authorization applications (NDAs/BLAs/MAAs), international roll out of post approval changes, related health authority queries (HAQs) during the regulatory procedure, Annual Reports/DSURs/PSURs/PBRER and associated prescribing information texts; etc.
• Providing coaching, mentoring and knowledge sharing within the RAM skill group.
• Contributing to process improvement.

You Will Need To Have
• 2+ years’ experience in Regulatory Affairs within the pharmaceutical industry is required; biotech is a plus
• Working knowledge of Agency regulations and industry standards pertaining to regulatory is essential
• Initial experience on regulatory submissions
• Good communication experience with regulatory agencies
• Understand context and content of regulatory submissions
• Good English oral and written communication skills are required
• Understanding of requirements for regulatory submissions
• Ability to support projects to completion/ experience working in project teams
• Ability to work in a flexible environment to meet all regulatory requirements and business requirements
• Good organizational skills
• Some travels required
• Pharmacist or equivalent education in a life science (biology, chemistry, etc.)
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We Would Prefer For You To Have
• Knowledge of the drug development process is highly preferred

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
Dublin Ireland

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