Zenas BioPharma · 1 day ago
Director, Global Regulatory Affairs
Waltham, MA
Full-time
Onsite
Director/Executive
$192K/yr - $240K/yr
10+ years expZenas BioPharma is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for autoimmune diseases. The Director of Regulatory Affairs will oversee regulatory activities for investigational products, lead submissions, and ensure compliance with regulatory standards.
BiopharmaHealth CarePharmaceutical
Responsibilities
Lead global and/or regional regulatory team on assigned projects and manage direct report(s)
Develop and execute global regulatory strategy and contingencies for assigned projects
Prepare/coordinate/review the nonclinical and clinical content of IND/CTAs, protocol/information amendments, and NDA/MAA. Lead regulatory submission teams for assigned projects per agreed upon/required timelines
Monitors evolving global regulatory guidance/regulations and ensures Zenas’s regulatory submissions comply with all document/file formats and structures
Authors and/or collaborates on standard operating procedures for the regulatory function
Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions for assigned programs
Represent Regulatory Affairs on various cross-functional teams, including Development, Project Teams, Study Teams, and relevant Sub Teams
Supports budgeting and forecasting activities for the Regulatory function
Maintain knowledge of global competitive landscape, regulatory environment, regulations, and guidance. Contribute to the development and maintenance of Regulatory Affairs working practices and procedures
In collaboration with the Regulatory team, design, implement, drive, and monitor global Regulatory strategies to inform Zenas’ programs
Perform other regulatory related duties as assigned
Qualification
Required
A BS, or advanced degree, preferably in life/physical sciences
A minimum of 10 years regulatory affairs experience within the pharmaceutical or biotechnology industry
Prior experience in developing both US and global regulatory strategies
Knowledge of small molecules development and regulatory processes. Understanding of biologics and combination products development process is preferred but not required
Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. Ability to work effectively within a team in a fast-paced changing environment
Independently motivated, detail oriented and good problem-solving ability. Ability to make independent, timely, and risk-based decisions (think outside of the box mentality)
Excellent written and verbal communication skills
Experience interacting with key functional stakeholders (clinical development, clinical operations, QA, technical operations, supply chain)
Comfortable working in a demanding, fast-paced, start-up culture with evolving processes. Flexible and able to adapt to new situations as the business demands
Demonstrates flexibility to work non-traditional work hours when needed, given international operations across time zones
Benefits
Annual performance bonus
Equity
Full range of benefits
Other incentive compensation plans
Company
Zenas BioPharma
Zenas BioPharma is a biopharmaceutical company that focuses on developing immune-based therapies for patients.
51-200 employees
H1B Sponsorship
Zenas BioPharma 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 (2)
2024 (1)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$513MKey Investors
Royalty PharmaEnavate Sciences
2025-10-08Post Ipo Equity· $120M
2025-09-02Post Ipo Debt· $75M
2024-09-13IPO
Leadership Team
Lonnie Moulder Jr
Chairman
Orlando Oliveira
Chief Commercial Officer
Recent News
2026-01-07
2026-01-06
Company data provided by crunchbase