Director, Global Regulatory Affairs, Development Strategy

This is what you will do:

Developing and implementing US regulatory development strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. 

You will be responsible for:

Developing and directing innovative and effective regulatory strategies in support of specific projects, and across projects in the Alexion portfolio.Serving as US Strategy lead on assigned programs. Acting as submission sub-team lead for US submissions and is core member of Regulatory Subteam (RST) for assigned programs.Providing advice on regulatory issues for both marketed and pipeline products; actively collaborates with management, Global Regulatory Lead 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.).Accountable for preparation and execution of regional aspects of the regulatory global strategy. Can include setting direction for junior staff to execute regional regulatory tasks according to strategy.Representing Alexion as point contact FDA and leading Alexion delegation for regulatory authority meetings. Leading US submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new clinical trial protocols, new marketing authorization applications, etc. Monitoring the development of new regulatory requirements or guidance documents and advising product teams of the impact on the business or development programs. Providing 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.

You will need to have:

10+ years of Regulatory experience in the pharmaceutical industry, with experience in regional regulatory strategies.Postgraduate degree relevant to the role (MSc)Strong knowledge of US drug development and regulatory policy; excellent scientific and business judgment.Experience providing US strategic regulatory advice for the global development of products through all stages of development including pre-approval and marketed compounds.Experience with leading major submissions and FDA meetingsAbility to manage complex issues and coordinate multiple projects  simultaneouslyAbility 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 assessmentHighly 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.

We would prefer for you to have:

Experience in Advisory CommitteeExperience in cell and gene therapyPhD degree relevant to the role

The annual base pay for this position ranges from $173,600.80 - $260,401.20. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

19-Dec-2024

Closing Date

01-Jan-2025Alexion 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 accommodations@Alexion.com. Alexion participates in E-Verify.