Sr. Manager, Regulatory Affairs Strategy

Position Summary:

The Sr. Manager, Regulatory Affairs role is 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 Sr. Manager, 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 reports to the Director, Regulatory Affairs.

Key Responsibilities:

• Develop and implement global regulatory strategy for assigned projects.
• Lead the preparation of lifecycle submissions, which may include IND amendments, Annual Reports, Meeting Documents, Special Designations, and Clinical Trial Applications.
• Prepare/coordinate/review the nonclinical and clinical content of new INDs and NDA/BLA/MAA.
• Serve as the primary interface with project specific regulatory contract organizations for coordination and preparation of submissions.
• Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Teams and Study Teams.
• Supports budgeting and forecasting activities
• Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidance and establish a process and communication plan with support of regulatory team to inform Zenas of new regulatory intel on a government and/or industry level. Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.

Qualifications:

• BS degree required; advanced degree preferred in life/physical sciences
• A minimum of 4 – 6 years regulatory affairs experience within the pharmaceutical or biotechnology industry or related healthcare field.
• Prior experience in developing both US and global regulatory strategies
• Knowledge of biologics and combination products development process is a plus
• Ability to work effectively within a team in a fast-paced changing environment.
• Demonstrate the ability to navigate in an evolving 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)
• 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 $144,800 to $181,000. 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 an annual performance bonus, equity, full range of benefits and other incentive compensation plans.