Vice President, 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 Vice President, Regulatory Affairs that will serve as a critical role in the organization, coordinating regulatory activities across vendors, Key Opinion Leaders and the internal team as the Company prepares for upcoming meetings with regulatory authorities. The successful candidate will work closely with the leadership team to set global regulatory strategy and execute at the highest levels as Encoded’s programs enter clinical trials.
Workplace Model: Hybrid or Remote
- Work closely with senior company leadership to build and execute an effective and efficient regulatory strategy for the US, EU, and other major global markets.
- Manage the interface with outside regulatory agencies and trade organizations and act as the main regulatory advisor/liaison for the company.
- 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.
- Develop and manage regulatory work plans for major submissions, health authority interactions, and other relevant activities, covering strategy, documentation, delegation and functional area collaboration, and budget.
- 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 (8+) years of experience working in pharma/biopharmaceutical Regulatory Affairs required.
- Solid understanding of drug development regulatory requirements and processes, including CMC considerations for gene therapy products.
- 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.
- Experience with Pediatric Exclusivity, Pediatric Investigational Plans and other aspects of pediatric drug development strongly preferred.
- Management experience (direct reports in Regulatory Affairs), with demonstrated ability to recruit, train, develop and retain strong performers preferred.
- Experience collaborating with Key Opinion Leaders, Scientific Advisors, consultants, contractors, CROs preferred.
- 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
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.