Regulatory Submission and Project Management Specialist
About the position
In support of our continued growth, we are looking for a Global Regulatory Submission Management Specialist to join our Global Regulatory Team. This is a highly visible role with excellent career development opportunities within Global Regulatory Affairs for motivated candidates. The position reports into the Global Regulatory Lead for one or more programs.
Responsibilities
ā¢ Responsible for management of asset-level global regulatory submission planning including annual reporting and ad hoc submissions for both development programs and post-approval life cycle management.
ā¢ Responsible for the planning and tracking of routine and ad hoc US, EU, and Global regulatory submissions, monitoring the submission forecast and ensuring high quality, compliant and validated submissions to health authorities within required timelines.
ā¢ Manages submission calendar, creates content plans for lifecycle and global submissions across multiple global applications, creates timelines and oversees responsibility matrices through cross-functional discussions, and tracks submission deliverables to maintain the target filing date.
ā¢ Proactively communicates issues or delays related to the completion of planned submissions.
ā¢ Liaises with cross-functional collaborators to gain alignment and ensure that submission requirements and timelines are understood.
ā¢ Effectively manages multiple projects and competing priorities.
ā¢ Maintains regulatory trackers for assigned programs, including submission calendar, archives of regulatory submissions, correspondence and commitments.
ā¢ May assist in management of special projects as needed (e.g., oversight of system/process improvement projects).
ā¢ Assist with regulatory inspection readiness activities.
Requirements
ā¢ Bachelor's degree preferred, scientific and/or computer science field preferred
ā¢ At least 1 year of relevant pharmaceutical experience (or relevant internship experience within a graduate-level degree program)
ā¢ Requires eCTD knowledge
ā¢ Working knowledge of the drug development process
ā¢ Solid understanding of regulatory requirements and submission processes
ā¢ Excellent collaboration and time management skills; ability to handle multiple work assignments concurrently; ability to coordinate and prioritize conflicting deadlines
ā¢ Strong organizational skills with detail-oriented focus
ā¢ A demonstrated ability to work with minimal supervision
ā¢ Excellent verbal and written communication skills
ā¢ Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs.
Nice-to-haves
ā¢ RAC certification desirable
ā¢ Knowledge of Veeva RIM Suite preferred
ā¢ Experience with StartingPoint templates preferred
Apply Now
Apply Now
In support of our continued growth, we are looking for a Global Regulatory Submission Management Specialist to join our Global Regulatory Team. This is a highly visible role with excellent career development opportunities within Global Regulatory Affairs for motivated candidates. The position reports into the Global Regulatory Lead for one or more programs.
Responsibilities
ā¢ Responsible for management of asset-level global regulatory submission planning including annual reporting and ad hoc submissions for both development programs and post-approval life cycle management.
ā¢ Responsible for the planning and tracking of routine and ad hoc US, EU, and Global regulatory submissions, monitoring the submission forecast and ensuring high quality, compliant and validated submissions to health authorities within required timelines.
ā¢ Manages submission calendar, creates content plans for lifecycle and global submissions across multiple global applications, creates timelines and oversees responsibility matrices through cross-functional discussions, and tracks submission deliverables to maintain the target filing date.
ā¢ Proactively communicates issues or delays related to the completion of planned submissions.
ā¢ Liaises with cross-functional collaborators to gain alignment and ensure that submission requirements and timelines are understood.
ā¢ Effectively manages multiple projects and competing priorities.
ā¢ Maintains regulatory trackers for assigned programs, including submission calendar, archives of regulatory submissions, correspondence and commitments.
ā¢ May assist in management of special projects as needed (e.g., oversight of system/process improvement projects).
ā¢ Assist with regulatory inspection readiness activities.
Requirements
ā¢ Bachelor's degree preferred, scientific and/or computer science field preferred
ā¢ At least 1 year of relevant pharmaceutical experience (or relevant internship experience within a graduate-level degree program)
ā¢ Requires eCTD knowledge
ā¢ Working knowledge of the drug development process
ā¢ Solid understanding of regulatory requirements and submission processes
ā¢ Excellent collaboration and time management skills; ability to handle multiple work assignments concurrently; ability to coordinate and prioritize conflicting deadlines
ā¢ Strong organizational skills with detail-oriented focus
ā¢ A demonstrated ability to work with minimal supervision
ā¢ Excellent verbal and written communication skills
ā¢ Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs.
Nice-to-haves
ā¢ RAC certification desirable
ā¢ Knowledge of Veeva RIM Suite preferred
ā¢ Experience with StartingPoint templates preferred
Apply Now
Apply Now