MannKind Corporation · 4 hours ago
Manager, Regulatory Operations
Burlington, MA
Full-time
Onsite
Senior Level
7+ years expMannKind Corporation is a biopharmaceutical company focused on transforming chronic disease care through innovative solutions. The Regulatory Operations Manager will lead the planning, preparation, and management of global regulatory submissions, ensuring compliance and quality while collaborating with cross-functional teams.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Lead the end‑to‑end 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 submission‑related activities and issue resolution
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
Maintain up‑to‑date 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
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
Qualification
Required
Bachelor's 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 hands‑on 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 fast‑paced environment
Excellent organizational skills, attention to detail, and communication abilities
Preferred
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 mid‑sized or rapidly growing biotech/pharma environment
Project management training or certification
Company
MannKind Corporation
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions.
501-1000 employees
H1B Sponsorship
MannKind Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (3)
2023 (2)
2022 (6)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$475MKey Investors
Blackstone GroupDeerfield Capital Management
2025-08-06Post Ipo Debt· $75M
2021-03-02Post Ipo Debt· $200M
2018-12-01Post Ipo Equity· $40M
Leadership Team
Michael Castagna
Chief Executive Officer
Christopher Prentiss
Chief Financial Officer
Recent News
2026-01-09
GlobeNewswire
2025-12-24
2025-12-24
Company data provided by crunchbase