About Freyr
Freyr is a fast‑growing, innovative company specializing in providing end‑to‑end regulatory solutions and services for the Life Sciences industry. We assist pharmaceutical, medical device, and biotech companies in navigating the complexities of regulatory compliance.
Position: Submission Planner
Freyr seeks a skilled Regulatory professional to join our team and shape the future of regulatory services.
Job Description
- The Submission Planner will work closely with client & regulatory department (EU/ROW & US region)
- Leads the execution of submission planning work including acquisition of ancillary docs and publishing.
- Work closely with stakeholders to drive the identification, planning, resourcing, execution and management of activities that deliver high‑quality regulatory submissions.
- Supports regulatory submission creation and registration tracking of the company’s submission targets from an operational perspective for the applicable region.
- Creates the submission component plan in planning tools following standard guidelines and client SOP. This plan will be shared with publishing to produce the submission.
- Leads cross‑functional submission planning meetings with the Regulatory Project Management Group.
- Updates schedule as per submission milestones and tracks it.
- Coordinates among stakeholders to obtain necessary information & documents for the plan.
- Identifies risks and issues with the submission and communicates with relevant stakeholders, including management.
- Performs quality checks of the submission plan.
- Performs quality checks after submission is built and before release to health authorities.
- Secures confirmation from the publishing team about submission release and requests acknowledgement receipts after successful dispatch.
- Closes the request in the tracking system upon successful completion.
Seniority level
Associate
Employment type
Full‑time
Job function
Other
Industries
Pharmaceutical Manufacturing
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