Senior Manager, Regulatory Affairs US Lead

Alexion • Boston, MA

3d

About The Position

The Senior Manager, Regulatory Affairs US Lead is responsible for leading, planning, preparing, and delivering regulatory strategies and activities for assigned products and projects in the United States, supporting global regulatory strategies and successful registration and lifecycle management of complex products for rare diseases and unmet medical needs. The role provides tactical and strategic regulatory input and leadership across regulatory and cross-functional teams to support regional and global business objectives.

The position works with business partners and regulatory authorities, including serving as Alexion’s point of contact with the US FDA and planning and managing regulatory authority meetings. It also oversees operational activities for regulatory authorizations, supports internal governance and advisory bodies, and contributes to regulatory processes, procedures, and inspection or audit support. The role collaborates with teams including Commercial and Medical and stays current with applicable regulatory requirements and trends.

Alexion is AstraZeneca’s Rare Disease unit. The company describes its work as patient-centered, collaborative, science-driven, and supported by tailored development opportunities. The annual base pay range is $109,244.80–$163,867.20. The position is eligible for short-term incentive bonuses and, for salaried roles, equity-based awards. Benefits include qualified retirement programs, paid time off, and health, dental, and vision coverage, subject to applicable plan terms.

Requirements

• At least 3 years of relevant regulatory experience in the pharmaceutical industry, including experience with US regional regulatory strategies.
• Bachelor’s degree required.
• Experience providing strategic regulatory advice in relevant jurisdictions, such as the US, for global product development through all stages, including pre-approval and marketed assets.
• Ability to lead multiple projects simultaneously in a time-sensitive environment.
• Ability to build relationships and collaborate in a global team environment at all organizational levels, including Senior Management.
• Strong interpersonal, written and verbal communication, and presentation skills.
• Consistent track record of sound judgment in risk assessment.
• Familiarity with new and emerging regulations and guidance.
• Understanding of GxPs in relevant areas and ability to locate and interpret regulatory information.
• Excellent use of Microsoft 365 tools, particularly PowerPoint.
• Proficiency in English in a corporate setting.

Nice To Haves

• Relevant postgraduate degree, such as an MSc, PharmD, or PhD.
• Experience working in a regulatory documentation system such as Veeva.
• Additional languages.

Responsibilities

• Develop and implement US regulatory strategies for assigned projects and products, and provide regulatory advice to cross-functional strategies and deliverables in line with business objectives.
• Manage and execute US regulatory submissions, including INDs, BLAs/NDAs, orphan drug designation applications, and pediatric submissions, collaborating with Regulatory and cross-functional teams.
• Represent Alexion as a contact with the US FDA and other relevant external partners, including planning and managing regulatory authority meetings in alignment with global and cross-functional strategy.
• Oversee operational activities related to regulatory authorizations in accordance with applicable internal and external requirements.
• Support the Global Regulatory Lead in internal governance and advisory bodies and other relevant internal activities, including selected regulatory processes and procedures and inspection or audit support.
• Collaborate with Regulatory teams and Enterprise functions, including Commercial and Medical, to provide regulatory input on business-relevant deliverables.
• Stay current with and apply regulatory requirements and trends in the assigned jurisdiction and focus area, such as clinical development and lifecycle management.
• Demonstrate exemplary behavior, leadership, ethics, and visibility within the Enterprise and with health authorities and external partners.

Benefits

• Eligibility for short-term incentive bonuses.
• Equity-based awards for salaried roles.
• Qualified retirement programs.
• Paid time off, including vacation, holidays, and leaves.
• Health coverage.
• Dental coverage.
• Vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior