Director, Regulatory Affairs, Regulatory Science & Execution
Director, Regulatory Affairs, Regulatory Science & Execution
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Job Description
This is what you will do:
The Regulatory Affairs Director (RAD) Regulatory Science & Execution will be accountable for the development implementation and maintenance of regulatory strategies for assigned project(s)/product(s) and regulatory jurisdiction(s) with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.
This individual will provide tactical and strategic input to and leadership across regulatory and crossfunctional teams with the objective of delivering according to regional and global Business Objectives. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.
You will be responsible for:
Accountable as Regulatory Lead to develop and implement regulatory strategies for assigned highly complex project(s)/product(s) across the assigned jurisdiction(s) and accountable to provide regulatory advice to crossfunctional strategies and associated deliverables according to business objectives with limited oversight.
Accountable for the regulatory execution of submissions in the relevant regulatory jurisdiction(s) by actively collaborating with other Regulatory functions and crossfunctional teams (e.g. clinical trial applications marketing authorization applications orphan drug designation applications paediatric submissions etc.).
Leads the planning and conduct of regulatory authority meetings in relevant jurisdiction(s) in alignment with global regulatory and crossfunctional strategy. Represents Alexion as point contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders.
Actively collaborate with Senior Management and Enterprise functions (e.g. Clinical Commercial Medical Affairs amongst others) to provide regional regulatory insight and broader drug development expertise.
Actively be up to date on latest regulatory requirements and trends and contribute to the shaping of the regulatory science environment. Support regulatory intelligence and policy priorities based on Alexion and AstraZenecas internal knowledge and expertise. Champion opportunities for regulatory innovation approaches and present such strategies and plans to management and appropriate crossfunctional teams.
Supports relevant internal activities including development and management of select Regulatory processes and procedures as well as inspection/audit support.
Demonstrate strategic leadership skills contributing to effective product development. Provide team leadership and participate in mentoring and performance feedback to regulatory and crossfunctional colleagues.
Ensure exemplary behavior leadership ethics and transparency within the Enterprise with Health Authorities and other external stakeholders.
You will need to have:
8 years of relevant Regulatory experience in the pharmaceutical industry with experience in US regional regulatory strategies.
Bachelors Degree
Strong knowledge of drug development and regulatory environment coupled by excellent scientific and business judgment.
Experience providing strategic regulatory advice in several regulatory jurisdiction(s) (e.g. EU US Canada UK) for the global development of products through all stages of development including preapproval and marketed assets.
Ability to manage complex issues and lead multiple projects simultaneously in a timesensitive fashion.
Ability to build intra and interteam relationships and collaborate in a global team environment at all levels of the organization especially Senior Management.
Strong interpersonal written/verbal communication and presentation skills.
Proven track record practicing sound judgment as it relates to risk assessment
Highly familiar and knowledgeable of new and emerging regulations and guidances. Understanding of GxPs at relevant areas and solid understanding of where to seek and how to interpret regulatory information.
The annual base pay for this position ranges from $173600.80 $260401.20. Hourly and salaried nonexempt 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 jobrelated knowledge skills and experience. In addition our positions offer a shortterm incentive bonus opportunity; eligibility to participate in our equitybased longterm 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 atwill 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
07May2025Closing Date
12May2025Alexion 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 Alexion participates in EVerify.Required Experience:
Director
Employment Type
Full-Time
