Director, Global Regulatory Affairs

Zenas BioPharma•Waltham, MA

1d•Hybrid

About The Position

The Director, Regulatory Affairs (RA), will be the Global Regulatory Lead for a multi-indication late phase investigational product responsible for leading and overseeing global filings including US and EU, and advancing Phase 2 indications by contributing to clinical development and registrational planning. The Director, RA will also have oversight of the regulatory plans for at least one early phase investigational product, leading and overseeing the writing and submission of IND/CTA/amendments and future marketing application submissions, providing guidance to the team on regulatory filings and responses, and critical regulatory intelligence. The Director, RA will participate in a cross-functional team, partners with key internal/external team members/stakeholders, and partner with Regulatory CMC, Medical Writing and Regulatory Operations to ensure the scientific data and submissions fulfills agency expectations in a compliant manner. This position will report to the Executive Director, Global Regulatory Affairs and will have at least one direct report.

Requirements

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 late phase experience including filing of marketing applications in the US and developing both US and global regulatory strategies
Knowledge of biologics development and regulatory processes. Understanding of small molecules 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.

Nice To Haves

Understanding of small molecules and combination products development process is preferred but not required.

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 BLA/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.