Regulatory Operations Manager
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Job Location:
Burlington, CO - USA
Monthly Salary:
Not Disclosed
Posted on:
8 hours ago
Vacancies:
1 Vacancy
Job Summary
Company Overview
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative patient-centric solutions. With a focus on cardiometabolic and orphan lung diseases we develop and commercialize treatments that address serious unmet medical needs including diabetes pulmonary hypertension pulmonary fibrosis nontuberculous mycobacterial (NTM) lung disease and fluid overload associated with heart failure and chronic kidney disease.
At MannKind our employees are our greatest asset. We foster a close-knit collaborative culture where every team member plays a vital role in our mission. We are proud to champion a rich blend of backgrounds perspectives and working styles as we work together to improve health outcomes and change lives.
Position Summary
The Regulatory Operations Manager will play a critical role in planning preparing and managing global regulatory submissions with a strong emphasis on eCTD publishing and lifecycle management. This individual will ensure submissions are compliant highquality and delivered on time to global health authorities. The role requires close collaboration with crossfunctional partnersincluding Regulatory Affairs CMC Clinical and Qualityto support regulatory strategy and execution across development programs.
Key Responsibilities
Submission Planning & Management
- Lead the endtoend planning coordination and execution of global regulatory submissions (IND/CTA NDA/MAA amendments supplements responses to queries and annual reports).
- Develop and maintain submission timelines deliverable trackers and communication plans to ensure alignment across functional teams.
- Serve as the primary internal point of contact for submissionrelated activities and issue resolution.
eCTD Publishing & Lifecycle Management
- Prepare compile and publish electronic submissions in eCTD format in accordance with regional requirements (FDA EMA Health Canada PMDA and other global authorities).
- Manage submission lifecycle activities including sequence planning metadata management and archive maintenance.
- Ensure submissions meet all technical standards validation criteria and regulatory guidance.
Compliance & Quality
- Maintain uptodate knowledge of global electronic submission standards regulatory requirements and industry best practices.
- Oversee document formatting QC and version control to ensure accuracy and consistency.
- Support inspection readiness and contribute to continuous improvement of regulatory operations processes templates and systems.
CrossFunctional Collaboration
- Partner closely with Regulatory Strategy Teams to support and ensure alignment on submission content and timelines.
- Work with Product Development (CMC and Device) Clinical Manufacturing Nonclinical and Quality teams to coordinate document delivery and resolve content or formatting issues.
- Provide guidance to authors on document standards templates and submission expectations.
Required Qualifications
- Bachelors degree preferably in a scientific or technical discipline.
- 7 years of experience in Regulatory Operations within the pharmaceutical or biotechnology industry.
- Demonstrated expertise in global eCTD publishing including handson experience with major publishing tools and validation software.
- Strong understanding of global regulatory requirements and electronic submission standards (FDA EMA ICH etc.).
- Proven ability to manage multiple submissions and deadlines in a fastpaced environment.
- Excellent organizational skills attention to detail and communication abilities.
Preferred Experience
- Experience supporting major submissions such as IND NDA BLA or MAA.
- Familiarity with regulatory information management systems (RIMS) and document management systems (DMS).
- Knowledge of emerging global electronic submission requirements (e.g. eCTD 4.0).
- Prior experience in a midsized or rapidly growing biotech/pharma environment.
- Project management training or certification.
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Drawing on the legacy of innovator and humanitarian Alfred E. Mann, our team of passionate scientists, researchers, and professionals develops cutting-edge therapeutic products and technologies that help people take control of their health and live—fully humann.
