Senior Director, Regulatory Affairs
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.
Encoded is seeking a Senior Director, Regulatory Affairs (reporting to the Vice President of Regulatory Affairs) who will contribute to the global clinical regulatory strategy by working cross-functionally in the organization, coordinating regulatory activities across vendors, and consulting Key Opinion Leaders as Encoded advances clinical development of its gene therapies. The successful candidate will work closely with the leadership team to help determine global regulatory strategy, ensure compliance with applicable global regulations, and join a high performing team dedicated to enabling the successful initiation and continuation of clinical trials for Encoded’s programs.
Workplace Model: Hybrid or Remote
- Work closely with cross-functional leaders to build and execute an effective and efficient regulatory strategy for the US, EU, and other major global markets.
- Partner with other company leaders to implement that strategy through execution of the product development plan according to the target product profile, focusing on target product characteristics, developmental risk assessment and regulatory risk management, and target product claims.
- Provide operational input into the development of nonclinical and clinical documents supporting global regulatory filings, including writing of relevant portions and regulatory review for appropriate compliance.
- Contribute to regulatory aspects of clinical operations including expedited adverse event reporting, study site training, audits and compliance and financial disclosures.
- Coordinate responses to regulatory information requests from health authorities.
- Work with Clinical Operations to ensure the acquisition and maintenance of appropriate IRB and related Ethics Committee approvals.
- Develop and cultivate important relationships with internal and external partners and stakeholders.
- Stay informed and abreast of the external landscape as it relates to assigned projects and relay this information internally.
- Ensure consistency of regulatory message content across publications and other enduring materials.
- Ensure annual licenses, registrations, and other relevant listings are maintained.
- Assess regulatory impacts associated with the changes made in the development of products.
- BS with a relevant scientific background required; MS, MD, PhD, PharmD or equivalent in a relevant scientific discipline highly desirable.
- Minimum (10+) years of experience working in pharma/biopharmaceutical with 8+ years in Regulatory Affairs required.
- Solid understanding of drug development regulatory requirements and processes.
- Deep knowledge of how nonclinical and clinical development plans, research designs, and study outcomes related to the target product profile and claims.
- Familiarity with major Guidance documents, GXP/ICH requirements, and regulatory/safety considerations in major markets, especially US and EU.
- Thorough understanding of electronic submissions for ICH/FDA compliance to electronic Common Technical Document (eCTD) standards required.
- Experience with major regulatory dossier filings (IND/IMPD, BLA, CTA, NDA, MAA) and routine compliance activities (expedited safety reporting, Patient Risk Management Plans, PSURs, other routine pharmacovigilance activities, regulatory audits and inspections) required; experience with regulatory defense activities including written response submissions, complex negotiations (e.g. labeling discussions), and FDA Advisory Committees and/or EMA CHMP interactions preferred.
- Experience with rare disease, and/or gene or cell therapy required
- Experience with adaptable design, early/accelerated approvals, creative approaches to regulatory landscape, balancing multiple inputs from internal and external stakeholders desired.
The anticipated salary range for candidates who will work in California is $225,000 – $295,000. 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.
- 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.