Director, Regulatory Affairs US Lead

Location: Seaport Boston

Reports to: Senior Director Global Regulatory Strategy

About Alexion

For over 30 years Alexion has been dedicated to transforming the lives of people living with rare diseases. We lead with breakthrough science deep disease understanding and a dedicated commitment to patients. As part of AstraZeneca we are uniquely positioned to accelerate innovation and reach more patients globally.

Working here means being driven by purpose acting with integrity and fostering a culture where people feel valued connected and a community that puts patients first plays to win and supports your development at every step.

Role Overview:

The Director Regulatory Affairs US lead 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 leadership across regulatory and cross-functional 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.

Key Responsibilities:

• Serving as US Strategy Lead on assigned programs. Acting as submission sub-team lead for US submissions and core member of the Global Regulatory Team (GRT) for assigned programs.

• Representing Alexion as point contact with FDA including leading and managing Agency meetings and providing support and coordination of briefing package development.

• Develops and directs innovative and effective regulatory strategies in support of assigned project(s)/product(s); 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 etc.).

• Monitors the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs.

• Ensures exemplary behavior ethics and transparency within the company and with regulatory agencies.

You will need to have:

Qualifications & Education

• 8 years of relevant Regulatory experience in the pharmaceutical industry with experience in US regional regulatory strategies.

• Bachelors degree in life science required; relevant postgraduate degree (e.g. MSc PharmD or PhD) is preferred.

• Strong knowledge of drug development and regulatory environment coupled by excellent scientific and business judgment.

• Experience providing strategic regulatory advice in relevant regulatory jurisdiction(s) (e.g. US EU Canada) for the global development of products through all stages of development including pre-approval and marketed assets.

• Ability to manage complex issues and lead multiple projects simultaneously in a time-sensitive fashion.

• Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization including 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.

Competences

• Excellent use of Microsoft 365 (Office) tools ideally well skilled on the use of PowerPoint
• Experience working in a regulatory documentation system (like Veeva).
• Proficient in English in the Corporate setting. Additional languages desirable.

Why Alexion

At Alexion(AstraZenecas RareDisease unit) workcentreson people living with rare conditions whose journeys demand new thinking every day; this means operating at the edge of science while staying grounded in real patient stories collaborating across subject areas to turn complexbiology into transformative medicines learning fast in an entrepreneurial environment with the backing of a global biopharma and growing through tailored development that deepens both leadership capability and compassion for patients and communities we serve.

If this opportunity to redefine what patient engagement can be resonates apply now to start the conversation!

The annual base pay for this position ranges from $186232.80 - $279349.20 USD Annual. Our positions offer eligibility for various incentivesan opportunity to receive short-term incentive bonuses equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs paid time off (i.e. vacation holiday and leaves) as well as health dental and vision coveragein accordance withthe terms of the applicable plans.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.