Job Description

Primary Function:

The Associate Director, Regulatory Affairs supports the development and execution of clinical regulatory strategies and regulatory development activities for assigned programs across regions. This role works closely with senior regulatory leadership to develop recommendations, execute regulatory plans, prepare submissions, and support health authority interactions. The Associate Director provides regulatory guidance to cross-functional teams and ensures regulatory deliverables are completed in accordance with applicable regulations, timelines, and internal standards.

This position reports to the VP, Regulatory Affairs and is based remote.

Major Responsibilities and Duties:

• Regulatory Strategy Support: Support the development and execution of clinical regulatory strategies for assigned programs under the direction of senior regulatory leadership, including contributing analyses, options, and regulatory recommendations.
• Regulatory Submissions: Plan, prepare, and manage Investigational New Drug (IND) applications and other pre- or post-IND regulatory submissions (e.g., amendments, briefing packages, and annual reports), ensuring accuracy, quality, and timely delivery. Manage regulatory timelines, deliverables, and commitments for assigned programs in coordination with cross-functional teams and ensure submission content is prepared in accordance with applicable electronic submission standards and internal processes.
• Health Authority Interactions: Prepare health authority meeting materials, responses to information requests, and supporting documentation, and participate in interactions with health authorities as part of the regulatory team.
• Regulatory Guidance: Provide day-to-day clinical regulatory guidance to cross-functional teams by interpreting regulations, policies, and guidance documents and applying them to program activities, including providing regulatory input into clinical development documents such as protocols, Investigator's Brochures, and study reports to ensure alignment with regulatory expectations.
• Compliance: Execute regulatory activities in compliance with applicable global and regional regulations industry guidelines, and internal policies and procedures, maintaining inspection-ready documentation and practices.
• Risk Identification: Proactively identify regulatory risks, issues, and gaps for assigned programs and develop mitigation approaches for discussion with regulatory leadership.
• Cross-Functional Collaboration: Lead clinical regulatory execution for assigned programs on cross-functional teams, coordinating inputs from Clinical, Nonclinical, Biometrics, Medical Writing, CMC, and other functions. Partner with CMC Regulatory Affairs and technical subject matter experts to ensure alignment of development and submission activities while maintaining primary responsibility for clinical regulatory strategy and execution.
• Regulatory Intelligence: Monitor regulatory developments relevant to assigned programs and assess potential impacts, communicating findings to regulatory leadership and program teams.
• Process Improvement: Actively contribute to the development, implementation, and continuous improvement of regulatory processes, templates, and tools to enhance efficiency and consistency.
• Professional Conduct: Execute responsibilities with professionalism, integrity, and attention to detail while working effectively across time zones and supporting a collaborative team environment.

Qualifications

REQUIRED:

• Bachelor's degree in life sciences with 10 years' experience in the biopharmaceutical industry of which 8 years are in regulatory affairs; or equivalent combination of education, training, and experience

PREFERRED:

• Advanced degree in life sciences, pharmacy, or a related field (MS, PhD, PharmD, or equivalent).
• Demonstrated experience preparing and managing INDs and supporting regulatory submissions.
• Experience supporting health authority interactions and cross-functional development teams.
• Working knowledge of regulatory requirements and processes in major markets (U.S. and/or EU).
• Strong written, verbal, and interpersonal communication skills.
• Ability to work effectively in a fast-paced, matrixed, and global environment.
• Maintains the highest standards of integrity and ethics.

Additional Information

The pay range for this position at commencement of employment is expected to be between $180k and $241K/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.