Remote opportunity at
MMSProject Manager II, Regulatory Submissions (Remote - US)
MMS is seeking a Project Manager II for Regulatory Submissions to join its team on a remote basis. As an award-winning and Great Place to Work…
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About This Role
MMS is seeking a Project Manager II for Regulatory Submissions to join its team on a remote basis. As an award-winning and Great Place to Work Certified clinical research organization, MMS provides scientific support to pharmaceutical, biotech, and medical device companies globally. This role suits professionals with experience in clinical research operations who want to contribute to complex trial data and regulatory submission hurdles within an inclusive work environment. In…
Job Description
MMS is seeking a Project Manager II for Regulatory Submissions to join its team on a remote basis. As an award-winning and Great Place to Work Certified clinical research organization, MMS provides scientific support to pharmaceutical, biotech, and medical device companies globally. This role suits professionals with experience in clinical research operations who want to contribute to complex trial data and regulatory submission hurdles within an inclusive work environment.
In this position, the professional will coordinate the creation and assembly of regulatory applications in collaboration with various functional departments. The job holder will oversee multiple client projects at once, track project finances, and facilitate communication across dispersed international teams. Successful candidates will balance high-volume workloads while maintaining client relationships and driving continuous process improvements.
Responsibilities
- Manage the planning and preparation of IND, NDA, and MAA submissions alongside functional leaders
- Collaborate with clinical, biometrics, regulatory writing, affairs, and operations teams to spot dependencies and manage risks
- Create and update comprehensive submission schedules that feature critical paths, resource allocations, and backups
- Handle multiple client accounts simultaneously to meet strict submission deadlines under heavy workloads
- Lead discussions, establish team consensus, track milestones, and report metrics to stakeholders
- Monitor project financials including budgets, invoicing, revenue recognition, profitability, and utilization
- Help with RFP scoping and pricing while articulating value propositions during business development talks
- Consult with clients to assess requirements and propose workable business solutions
- Run meetings for distributed teams, resolve conflicts, and foster collaboration
- Contribute to continuous improvement initiatives aimed at boosting team output and project results
Requirements
- Minimum of five years of relevant project management or coordination experience
- In-depth understanding of pharmaceutical development phases and NDA structures
- Proven background in building and overseeing integrated regulatory submission schedules
- Demonstrated ability to handle concurrent deliverables and high-volume client engagements
- Experience with financial tracking including project budgets, margins, and invoicing
- Working familiarity with drug development procedures and CRO operations
Qualifications
- Bachelor degree or equivalent relevant experience
- Prior filing experience with NDA and MAA strongly preferred
Core Skills
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
Is this position remote?
Yes, this role is listed with a remote status.
What experience level is required for this role?
Applicants need a bachelor degree or equivalent experience, along with at least five years of project management or coordination background.
What is the salary for this position?
The provided job posting does not specify a salary.
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