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.

Global Regulatory Lead, Regulatory Affairs Marketed Products Strategy, Regulatory & Quality Affairs

Location:

Paris, France

Reports To:

Director, Head of Product Cluster, Regulatory Affairs Marketed Products Strategy

Date:

09 January 2023

This is what you will do:
• The Global Regulatory Lead (GRL), Regulatory Affairs Marketed Products (RAMP) Strategy will be responsible for developing and implementing regulatory strategy leading to successful registration and... life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will, with a high sense of urgency, provide operational and strategic regulatory input to cross-functional teams responsible for global programs. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.

You will be responsible for:
• Working with manager to develop and direct innovative and effective regulatory strategies in support of product responsibilities which fall within the oversight of RAMP Strategy.
• Serving as global regulatory team leader on assigned products.
• Providing advice on regulatory issues for assigned products; actively collaborates with management and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.).
• Preparing and executing region-specific aspects of regulatory affairs and ensures integration into global regulatory strategy.
• Representing Alexion as point contact with regulatory authorities, including providing support for and coordination of regulatory meetings and information package development for assigned products.
• Coordinating submissions to regulatory authorities in support of proposed and ongoing established and commercial programs.
• Monitoring the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs Provides support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.
• Ensuring exemplary behavior, ethics, and transparency within the company and with regulatory agencies.
• Developing the international regulatory strategy.
• Developing the Product Plan.
• Providing support to submission teams/regulatory project managers (RPMs), if available, to resolve critical issues during the execution of roll-out and to resolve any critical post-approval issues.
• Providing strategic and tactical advice to the regulatory sub-team (RST) and contributing functions concerning post-approval commitments for assigned region.
• Ensuring that the agreed regional strategy is embedded into and is consistent/compatible with key regional functional regulatory documents, e.g., clinical study reports (CSRs), high level summary documents, response documents
• Evaluating impact of new data on the regulatory strategy, initial license, label and post approval commitments in assigned regions.
• Driving health authority (HA) interactions in concerned region, as necessary, to clarify regulatory requirements or facilitate meetings.
• Developing applicable regional strategic documents.
• Contributing to development of the prescribing information in the assigned markets.

You will need to have:
• Bachelor’s Degree in a related discipline
• 7 years in pharmaceutical industry regulatory affairs
• Strong knowledge of drug development as well as excellent scientific and business judgment.
• Experience providing strategic regulatory advice for the global development of products through all stages of development including pre-approval and marketed compounds.
• Proven leadership in regional/international regulatory strategies necessary to support international expansion.
• Ability to manage complex issues and coordinate multiple projects simultaneously.
• Ability to build intra-team relationships and collaborate in a global team environment at all levels of the organization.
• Strong interpersonal and written/verbal communication skills.
• Proven track record practicing sound judgment as it relates to risk assessment.
• Highly conversant and knowledgeable of new and emerging regulations and guidances. Understanding of GMPs, GLPs and GCPs; solid understanding of where to seek and how to interpret regulatory information.
• 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
Paris France

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