Senior Manager, Regulatory Affairs US Lead

AstraZeneca•Boston, MA

2d•Hybrid

About The Position

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.

Requirements

6+ years of relevant Regulatory experience in the pharmaceutical industry, with experience in US regional regulatory strategies.
Bachelor’s 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.

Nice To Haves

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.

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.