Senior Director, Global Regulatory Strategy

Location: Boston Seaport MA (US Headquarters for Alexion)

Additional Location: Gaithersburg

Hybrid: 3 days a week onsite

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 an unrelenting 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.

TheSenior Director Global Regulatory Strategy will be responsible forproviding senior regulatory leadership across execution teams and US regulatory strategists 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 bring ahigh sense of urgency strategic leadership and organizational influenceto the Regulatory organizationmentoring teams driving operational efficiencies and innovation and advancing standard processesto ensure high-quality execution across programs. The role will also develop effective communication and constructive working relationships with business partners and representatives of regulatory authorities.

You will be responsible for:

• Provides senior leadership to regulatory staff responsible for developing and implementing strategies and driving products and/or projectsin the relevant regulatory jurisdictions as assigned aligned to overall Enterprise objectives and global regulatory strategies through initial registration and subsequent lifecycle management.

• Serves as a senior leader across regulatory execution and/or regional strategist teams collaborating with other Regulatory functions to strengthen organizational capability support talent development and ensure delivery against resource and business needs for assigned products/programs (e.g. clinical trial applications marketing authorization applications orphan drug designation applications paediatric submissions etc.).

• Leads across assigned regulatory team(s) as a senior strategic partner collaborating with Global and Regional regulatory cross-department leaders to promote effective prioritization balanced workload distribution and high-quality delivery of key regulatory activities and achievements.

• Provides senior oversight to execution and regional strategy teams in the planning and conduct of regulatory authority meetings in relevant jurisdictions supporting to submission strategy and other critical regulatory documents. May represent Alexion as point of contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external partners.

• Supports provision of advice and input from execution and regional strategy teams tointernal Governance and advisory bodiesfrom which GRA staff can seek insight on strategic and procedural/operational issues as they arise.

• Actively collaborates withSenior Management and Enterprise functions(e.g. Clinical Commercial Medical Affairs amongst others) to provide regional regulatory insight broader drug development expertise and leadership oncritical business priorities and high-impact programs.

• Champions continuous improvement across regulatory operations finding opportunities to improve efficiency enhance cross-functional ways of working and implement innovative approaches that strengthen execution and organizational effectiveness.

• Leads the development and adoption of standard processes ensuring consistency quality and operational excellence across regulatory activities and enabling teams to respond effectively to evolving business and regulatory demands.

• Actively stays up to date on latest regulatory requirements and trends and supports to shaping the regulatory science environment supporting regulatory intelligence and policy priorities based on Alexion and AstraZenecas internal knowledge and expertise.

• Ensuresexemplary behavior leadership ethics and visibilitywithin the Enterprise with Health Authorities and other external partners.

You will need to have:

Qualifications

• 12 years of Regulatory experience in the pharmaceutical industry with experience in regional regulatory strategies primarily in the US.

• Strong knowledge of drug development and regulatory policy couple by excellent scientific and business judgment.

• Experience providing leading and managing cross-skilled regulatory staff to deliver on business objectives in mentoring and developing staff.

• Ability to manage complex issues and coordinate 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 especially Senior Management.

• 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 GxPs at relevant areas and solid understanding of where to seek and how to interpret regulatory information.

Education

Minimum requirement Bachelors Degree life science highly desirable

Preferred Postgraduate degrees relevant to the role (e.g. MSc PhD)

Additional certification and/or training relevant to the role over the past

Competences

Excellent use of Microsoft 365 (Office) tools ideally well skilled on the use of PowerPoint

Proficient in English in the Corporate setting. Additional languages are a plus

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 disciplines 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 empathy 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 $272573.00 - $327087.60 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.

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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.