Project Manager

3 weeks ago

Boston, United Kingdom SoftPathTechnologies Full time

Role: ProjectManager
Location: Alexion: Seaport HQBoston MA

Onsite: Monday TuesdayWednesday office Thurday Friday WFH .

Any Visa is okay NO CPT OPT or F1 No Third Party Subs OnlyW2 Candidates

Local candidatesonly


You will be responsible for:
Developing anddirecting innovative and effective regulatory strategies in supportof specific projects and across projects in the Alexionportfolio.
Serving as global or US Strategy lead onassigned programs. Acting as submission subteam lead for USsubmissions and is core member of Regulatory Subteam (RST) forassigned programs.
Providing advice on regulatory issuesfor both marketed and pipeline products; actively collaborates withmanagement Global Regulatory Lead and cross functional colleagueswithin Alexion (i.e. commercial research clinical developmentmedical affairs business development legal manufacturing qualityportfolio management financial human resources etc.).
Accountable for preparation and execution of regional aspects ofthe regulatory global strategy. Can include setting direction forjunior staff to execute regional regulatory tasks according tostrategy.
Representing Alexion as point contact FDA andleading Alexion delegation for regulatory authoritymeetings.
Leading US submissions to regulatoryauthorities in support of proposed and ongoing development programse.g. new clinical trial protocols new marketing authorisationapplications etc.
Monitoring the development of newregulatory requirements or guidance documents and advising productteams of the impact on the business or development programs.Providing support to regulatory affairs reviewers for due diligenceinitiatives including opportunity and risk assessment.
Ensuring exemplary behavior ethics and transparency within thecompany and with regulatory agencies.

Youwill need to have:
Strong knowledge of US drugdevelopment and regulatory policy; excellent scientific andbusiness judgment.
Experience providing US strategicregulatory advice for the global development of products throughall stages of development including preapproval and marketedcompounds.
Experience with leading major submissions andFDA meetings
Ability to manage complex issues andcoordinate multiple projects simultaneously
Ability tobuild intrateam relationships and collaborate in a global teamenvironment at all levels of the organization.
Stronginterpersonal and written/verbal communication skills.
Proven track record practicing sound judgment as it relates to riskassessment
Highly conversant and knowledgeable of newand emerging regulations and guidances. Understanding of GMPs GLPsand GCPs; solid understanding of where to seek and how to interpretregulatory information.
Bachelors Degree in a relateddiscipline

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