Director, Regulatory Operations

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-functional teamwork environment.
• Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
• Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
• Successful record of creating and managing complex project plans, timelines, budgets and critical paths.
• Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
• Demonstrated capacity to work in a highly matrixed working environment by interacting effectively with internal departments and external organizations.
• Ability to lead, train and mentor team members in multiple disciplines, as needed.
• Works independently under general supervision and exercises judgment within generally defined practices and policies.

The anticipated salary range for Director candidates who will work remote in the United States is $188,000 - $254,000. The anticipated salary range for Director candidates who will work in California is $216,000 - $292,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc. Encoded Therapeutics is a multi-state employer and this salary range may not reflect positions that work in other states.

A hired applicant may be eligible for an annual bonus as well as equity under the company’s stock plan.

Benefits

• Comprehensive benefits package, including competitive employer premium contributions
• Meaningful stock option grants
• PTO, sick time, and holiday pay
• Generous Parental Leave program
• Pre-tax medical and dependent care programs
• STD, LTD, Life and AD&D
• Professional development opportunities
• Team-building events
• Fully stocked kitchen
• Purple Tie dry cleaning service
• Fitness center

Employees (and their families) may obtain medical, dental, vision and basic life insurance benefits through the company and enroll in our company's 401k plan. Employees will also accrue vacation time off and paid sick time off and may become eligible for paid parental leave. Employees will also enjoy designated paid holidays throughout the calendar year.

Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages.

If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272.

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