Job Description

Rejuvenate Bio is seeking a motivated, flexible, creative, and strategic individual to build out and lead our global Regulatory Affairs team. This is a highly visible and collaborative role that will shape the company’s regulatory path throughout the product lifecycle from discovery through to post-approval. He/she will be responsible for all regulatory aspects of preclinical, CMC, and clinical drug development. Duties include developing and executing a comprehensive and strategic regulatory plan, highlighting risks and opportunities to the senior leadership team and building a regulatory team to ensure timely preparation, review and submission of clear and concise regulatory documents in compliance with applicable regulations and guidelines. The ideal candidate is a seasoned regulatory leader who has a deep understanding of the regulatory pathways for gene therapies in the US and globally.

This position is available on a fully remote or hybrid basis.

RESPONSIBILITIES:

• Working closely with executive management, lead the development of regulatory strategies and objectives that result in the successful registration and post-approval commercialization of Rejuvenate Bio products.
• Direct regulatory activities across the company’s portfolio, developing and implementing innovative global regulatory strategies, often where no precedent exists.
• Direct long and short-term departmental planning including structure, headcount, budgeting, training, and systems requirements.
• Serve as the Regulatory Affairs representative on cross-functional teams including project teams, quality oversight, etc.
• Build an internal team as necessary over time, responsible for all aspects of regulatory affairs, including regulatory strategy, regulatory CMC, regulatory intelligence, and regulatory operations, utilizing consultants and outsourcing vendors as appropriate.
• Regularly monitor the evolving gene therapy landscape and advise company on relevant changes, including interpretations of any new guidance and regulations
• Actively participate in key industry organizations, such as AGCT, ARM, etc.
• Establish and maintain effective professional relationships with FDA and global health authorities; including facilitating, negotiating, and resolving issues as needed.
• Author and/or review portions of key regulatory submissions such as INDs / CTAs, meeting requests, briefing documents, and responses to Health Authority questions
• Partner with and support clinical development, CMC, preclinical, quality, medical affairs, commercial and corporate activities, including the review and submission of clinical protocols and regulatory documents, publications, investor relations/legal public disclosures throughout the product life cycle.
• Provide regulatory oversight of program documents including target product profiles, development plans, and non-clinical and clinical protocols and reports.
• Ensure compliance with internal and external policies, guidance, and regulations.
• Manage internal regulatory procedures to ensure compliance.
• Other duties as assigned.

Qualifications

• Minimum BS Degree with 15+ years regulatory affairs experience in biotechnology, including multi-disciplinary experience, with 10 years CMC regulatory strategy (AAV-mediated gene therapy experience strongly preferred).
• Strong scientific background, with ability to translate highly scientific/technical information to achieve regulatory objectives.
• Proven ability to develop and implement a regulatory strategy that evolves and proactively adapts to changes in industry standards.
• Deep knowledge of all facets of Regulatory Affairs
• Experience in interfacing and responding to relevant global regulatory authorities, especially with respect to gene therapy products.
• Knowledge and understanding of US and international regulations and ICH guidelines related to CMC gene therapy development.
• Experience and knowledge in the preparation of CMC content for major global regulatory submissions including INDs, CTAs, license applications, and meeting briefing packages.
• Thrive in a fast‐paced environment combining strategic and tactical capabilities.
• Ability to anticipate and recognize ambiguous situations, and to assess risk and make decisions in uncertain situations.
• Strong oral and written communication skills with the ability to lead and influence at all levels of the organization.
• Ability to proactively define, plan, communicate and manage multiple initiatives simultaneously to achieve objectives

PREFERRED QUALIFICATIONS:

• Advanced Degree (PhD) with 15+ years of relevant Regulatory Affairs experience
• Prior experience as a regulatory contributor for original IND, NDA, MAA filings in the US and globally Europe for AAV gene therapy programs.

Additional Information

COMPENSATION: $250k - $280k; flexible DOE

EEO STATEMENT

_Rejuvenate Bio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Rejuvenate Bio is an E-Verify Employer in the United States. All your information will be kept confidential according to EEO guidelines. _

PHYSICAL REQUIREMENTS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Position is primarily sedentary, and employee may be required to sit for extended periods of time. 
• Standing, walking and meeting activities are required frequently throughout the workday. 
• Must be able to process paperwork and utilize office equipment (including personal computer, phone, copiers, etc.). 
• Normal sight or corrected vision is required to read documents and use standard computer terminals. Some light lifting may be occasionally required.
• Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.
• Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards
• Must be able to lift and carry up to 25 lbs
• Must be able to talk, listen and speak clearly on telephone

THE HEALTH AND SAFETY OF OUR EMPLOYEES AND THEIR FAMILIES IS A TOP PRIORITY. The company encourages employees to remain up-to-date on their COVID-19 vaccinations. Rejuvenate Bio, Inc. employees may be required, in the future, to be vaccinated or have an approved disability/medical or religious accommodation.