Zenas BioPharma · 7 hours ago
Senior Director, Regulatory Affairs CMC
Waltham, MA
Full-time
Hybrid
Director/Executive
$220K/yr - $275K/yr
12+ years expZenasbio is a clinical-stage global biopharmaceutical company committed to developing transformative therapies for autoimmune diseases. The Sr. Director, Regulatory Affairs CMC will lead the development and implementation of global regulatory CMC strategies, ensuring compliance and timely submissions for small molecule drug products.
BiopharmaHealth CarePharmaceutical
Responsibilities
Lead the development of the regulatory CMC strategy for assigned development products
Represent RA CMC on development teams and provide direction on the interpretation and application of CMC/Quality regulations and guidance documents
Prepare/coordinate/review the CMC content of IND/IMPD/NDA submissions, meeting packages and response to regulatory agency questions and requests
Lead teams for assigned CMC submission projects per agreed upon/required timelines
Provide strategic and regulatory compliance input on technical protocols, reports, and other source CMC documents
Ensure alignment of the regulatory CMC strategy with the corporate objectives through communication and collaboration with internal stakeholders and business partners. Escalate issues to Senior Management that may impact regulatory compliance and continued development of assets
Maintain a current knowledge of US and EU regulatory guidance, regulations, and competitive intelligence. Communicate key updates to Senior Management and project teams as appropriate, and ensure Zenas’s regulatory submissions comply with all regulations/guidelines
Represent Regulatory Affairs CMC on various cross-functional teams
Contribute to the development and maintenance of Regulatory Affairs working practices and procedures
Perform other regulatory related duties as assigned
Qualification
Required
A BS, or advanced degree, preferably in chemistry or life/physical sciences
A minimum of 12 years regulatory affairs experience (5+ years RA CMC) within the pharmaceutical or biotechnology industry
Prior experience in developing US and EU global regulatory strategies for small molecule drugs
Knowledge of small molecule chemistry and development processes
Prior experience in compiling module 3 CMC sections for IND/IMPD/NDAs
Experience interacting with key functional stakeholders (product development, manufacturing, QA, QC, supply chain)
Ability to influence across functions and levels within the organization
Self-motivated, self-disciplined and able to function independently as well as part of a team
Ability to prioritize, multi-task, and work in an evolving and high-pressure environment
Good presentation and excellent written/verbal communication skills
Demonstrates flexibility to work non-traditional work hours when needed, given international operations across time zones
Preferred
Experience managing people preferred
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
2026-01-11
Company data provided by crunchbase