Associate Director, Clinical Development

Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com.

Position details

This position reports to the Head of Regulatory Affairs and is responsible for operational aspects of global regulatory submissions, ensuring that submissions are high quality and submitted on a timely basis. This role is also responsible for archiving and tracking regulatory submissions and health authority correspondence. Emphasis will be on strategic planning, management, and execution of all aspects of Regulatory Operations. Additional key accountabilities include working with Regulatory Affairs, Medical Writing, Biometrics, Clinical, Medical, and Technical Operations subject matter experts and authors and Regulatory Agencies, to ensure documents and submissions comply with regulatory and company guidance /specifications.

Workplace Model: Remote

Responsibilities

• Collaborate with Regulatory Affairs, cross-functional teams, and external partners to plan, create, and submit regulatory health authority dossier and amendment, including original INDs, CTAs, IMPDs, and marketing applications in electronic or paper formats, as required (i.e., formatting, publishing, submitting, life-cycling, and archiving sequences).
• Oversee in-house technical aspects for health authority submissions; e, g., eCTD document granularity, utilization of content templates, document formatting, eCTD application location and lifecycle assignment, publishing, QC, validation, and transmission to regulatory health authorities (e.g., FDA ESG, MMA IRIS, CTIS).
• Serve as system owner for in-house regulatory information tools and systems (e.g., eCTD publishing tools, electronic document management system (EDMS), library system, and electronic templates).
• Maintain expert knowledge of electronic submission and computerized system validation standards.
• In collaboration with IT, ensure that in-house regulatory information tools and systems are implemented, validated, and maintained in accordance with company SOPs and applicable regulations.
• Develops departmental procedures outlining the generation of electronic submission‑ready documents.
• Serves as subject matter expert in dossier types and/or processes with responsibility for training and mentoring regulatory operations staff and representatives from cross‑functional teams.
• Identifies potential risks to submission plans and proposes risk mitigation strategies.
• Provides recommendations on resource needs for regulatory operations activities including the need for outsourcing (e.g., eCTD vendor, SPL vendor).
• Maintains current knowledge of FDA, Health Canada, EMA, and ICH requirements for regulatory submissions and ensures that all regulatory submissions comply with those requirements.

Requirements

• Degree in Life Science or applicable job experience may be considered.

• Minimum of 8-10 years’ regulatory experience in the pharmaceutical and biotechnology industry or Government Health Agency, with at least 5 years’ experience in a regulatory operations role.
• Strong professional experience in a similar role within the pharmaceutical industry, preferably small molecule pharmaceuticals.
• Demonstrated track record of successful approvals from a major regulatory agency is required.

• Detailed knowledge of and strong experience implementing, validating and managing eCTD publishing system and EDMS technology (e.g., Box, Veeva or Master Control).
• Expert knowledge of the eCTD structure and publishing software, and global requirements is required.
• Strong knowledge of submission data standards (CDISC) is required. Advanced proficiency using Microsoft Office Suite and Adobe Acrobat Professional is required.
• Advanced proficiency administering and maintaining document authoring templates.
• Ability to problem solve and troubleshoot under pressure to ensure timely and compliant submissions to global health agencies
• Continued assessment of revisions to requirements for electronic submissions, both pre- and post -approval.
• Team player capable of managing multiple projects and complex timelines in a team environment.
• Well organized with the ability to multitask, prioritize and manage shifting responsibilities in a dynamic, cross-