Associate Director, Regulatory Affairs

Position Summary

The Associate Director, Regulatory Affairs, will be responsible for day-to-day regulatory activities of early/late phase investigational products, leads the writing and submission of IND/CTA/amendments and future marketing application submissions, provides guidance to the team on regulatory filings and responses, and provides critical regulatory intelligence and guidance back to the team.  The AD, RA participates in a cross-functional team, partners with key internal/external team members/stakeholders, and partners with Regulatory CMC and Regulatory Operations to ensure the scientific data and submissions fulfills agency expectations in a compliant manner. This position will report to the Vice President, Head of Global Regulatory Affairs.

Key Responsibilities

• Lead global and/or regional regulatory team on assigned projects.
• 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.

Requirements/Qualifications

• A BS, or advanced degree, preferably in life/physical sciences
• A minimum of 6 – 10 years regulatory affairs experience within the pharmaceutical or biotechnology industry
• Prior experience in developing both US and global regulatory strategies
• Knowledge of biologics and combination products development process
• 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, 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.
• Ability to work effectively in hybrid model from virtual home and in office settings.
• Demonstrates flexibility to work non-traditional work hours when needed, given international operations across time zones.

#LI-Hybrid 

Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $154,400 to $193,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.

Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas’ competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.