Senior Manager, Regulatory Affairs US Lead

Location: Seaport Boston or Gaithersburg Maryland

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 Senior Manager Regulatory Affairs US lead will be responsible for leading planning preparing and delivering regulatory strategies and activities for assigned product(s)/project(s) across the assigned jurisdiction supporting global regulatory strategies 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 regulatory input and leadership across regulatory and cross-functional teams 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:

• Accountable as US Regulatory Lead to develop and implement regulatory strategies for assigned project(s)/product(s) in the US and accountable to provide regulatory advice to cross-functional strategies and associated deliverables according to business objectives.

• Responsible for the management and execution of regulatory submissions in the US (e.g. INDs BLAs/NDAs orphan drug designation applications pediatric submissions etc.) by actively collaborating with other Regulatory functions and cross-functional teams to deliver business objectives for assigned products/programs..

• Represents Alexion as point of contact with the US FDA or other relevant external partners including the planning and management of regulatory authority meetings in alignment with global regulatory and cross-functional strategy.

• Responsible for overseeing operational activities related to the Regulatory authorizations according to current regulatory internal and external requirements for the assigned jurisdiction(s).

• Supports the Global Regulatory Lead in internal Governance and advisory bodies or other relevant internal activities including the development and management of select Regulatory processes and procedures as well as inspection/audit support.

• Actively collaborates with other Regulatory teams and Enterprise functions (e.g. Commercial Medical) to provide regulatory input to business-relevant deliverables concerning assigned project/product and jurisdiction.

• Actively be up to date on and efficiently apply latest regulatory requirements and trends within assigned jurisdiction and regulatory focus area (e.g. clinical development lifecycle management).

• Ensure exemplary behavior leadership ethics and visibility within the Enterprise with Health Authorities and other external partners.

You will need to have:

Qualifications & Education

• 6 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.
• Experience providing strategic regulatory advice in relevant regulatory jurisdiction(s) (e.g. US) for the global development of products through all stages of development including pre-approval and marketed assets.
• Ability to run 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. Consistent track record practicing sound judgment as it relates to risk assessment.
• 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 $135624.80 - $203437.20 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.