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location: Cambridge, Massachusetts
job type: Contract
salary: $75.30 - 88.59 per hour
work hours: 9 to 5
- Responsible in assisting the planning, development and implementation of global regulatory strategies and actions in preparation for Major NDA/BLA/MAA submissions.
- Responsible for ensuring assigned deliverables to be included in NDA/BLA/MAA filings are delivered to agreed timelines by initiating, managing and driving the creation and review cycles for these deliverables and ensuring they are delivered to the appropriate Biogen Standards.
- Responsible for the successful development and execution of regulatory deliverables to be included in multiple planned major filing submissions from assignment of the incumbent to filing and beyond
- Assist with providing operational support and coordinate with relevant stakeholders
- Manage and drive timelines for review and delivery of final deliverables to be included in Major filings
- Facilitate the definition of project milestones, tasks, deliverables, key dependencies and resource requirements as needed to ensure agreed timelines are met.
- Identify in a timely manner and mitigate for regulatory risks associated with the execution of regulatory submission plan
- Anticipate issues and develop mitigation plans leading to issue resolution.Keep abreast of changes in regional legislation and highlight key issues that are derived from these changes that may impact the execution of Global regulatory submission plan e.g. change in eCTD Specification for Module 1.
- Build and maintain effective relationships with both internal as well as cross functional stakeholders
- Demonstrate strong organizational skills, including the ability to prioritize personal and Cross functional Team workload and priorities
- Work closely with the Regulatory/Regional Leads and Medical Writers to generate and maintain submission plans including table of contents, timeline and responsibility matrix.
- Work with the Regulatory Leads and MWs to conduct the kickoff meetings and run subsequent Submission Task Force meetings
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, drug safety, scientific, and manufacturing staff.
- Effectively communicate project status, issues, schedule and accomplishments to various management and stakeholder groups, as needed.
- Be adept at using project management tools to guide Regulatory teams to drive teams, to track timelines, manage interdependencies, identify bottlenecks, and resolve issues, working with the cross-functional team members
- Provide overall transparency and one source of timelines for the Submission
- Education: BA/BS/University degree required; Life/Health Sciences preferred
- Minimum 6-8 years pharmaceutical/biotechnology industry experience (including a minimum of 3 years + of relevant Regulatory Affairs experience).
- Experience with creating and maintaining regulatory submission plans for NDA/BLA/MAA would be highly desirable
- Previous experience working in a Global Environment/setting
skills: NDA, Maa, CTD Structure, Regulatory Affairs Operations, Regulatory Affairs Strategy, Submissions
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.