Location: Raleigh-Durham, NC
Who We Are
Enzyvant is a commercial-stage biotechnology company on the leading edge of regenerative medicine for rare diseases. Our lead asset is FDA-approved RETHYMIC®, a tissue-based regenerative therapy for an ultra-rare and life-threatening pediatric immunodeficiency. It is an exciting time for the Enzyvant team as we deliver on our patient purpose and execute on our bold vision for growth.
Patients are the heart and soul of Enzyvant, inspiring deep meaning, passion, and purpose in our work. They are all the reasons for why, how, and what we do. At Enzyvant, we see a world where the promise of our breakthrough biotechnologies is fully realized to transform the lives of patients battling devastating rare diseases. To achieve this vision, we are pursuing new uses and geographies for our biotechnologies and providing extensive support to help families navigate the complexity of rare diseases with our Enzyvant Connect program.
The Enzyvant team includes some of the most innovative talent in the regenerative medicine sector today. We attract people in biotech who want to make their mark in regenerative medicine and deliver truly meaningful, life-changing solutions for patients. Our company culture values teamwork, innovation, empowerment, and integrity. Enzyvant has a small company feel with the reach and resources of our global parent company Sumitovant Biopharma Ltd. (wholly owned by Sumitomo Dainippon Pharma Co., Ltd.)
The Director, Regulatory and Pharmacovigilance will be responsible for leading the development and execution of global regulatory strategies for innovative medicines that address unmet medical needs and bring significant value to patients in diverse therapeutic areas. A successful candidate will maintain focus on corporate goals while responding to the needs of project teams in a highly dynamic, fast-moving environment. This person will report to the Senior Vice President, Global Regulatory Affairs
- Preparation, review and submission of high-quality documentation for INDs, CTAs, NDAs, BLAs, MAAs, and related filings to Regulatory Agencies within established timeframes. Responsibilities will include original applications and product maintenance, such as information amendments and annual reports.
- Lead the development of competitive global regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. Ensure regulatory requirements and strategy are understood and met by project teams.
- Communicate project updates and risks to senior Regulatory and Pharmacovigilance management and stakeholders across the organization. Tracking regulatory commitments and deliverables while coordinating with internal and external staff to ensure timely submissions. Interact efficiently and independently with consultants.
- May serve as FDA liaison and provide leadership and support for global Regulatory Agency meetings and teleconferences.
- Maintain up-to-date knowledge on global regulatory requirements.
- Initiate and contribute to the development of policies and procedures in alignment with GxPs, Guidances, and corporate objectives in support of Regulatory and Pharmacovigilance.
- Lead and implement regulatory and PV systems and other infrastructure evolvement, as assigned, to include VEEVA Regulatory Information Management, regulatory document templates, and submission standards.
- Mentor, and develop other regulatory staff members.
- Lead efficient integration, including organization and compliance check, for documentation related to new product acquisitions and due diligence activities.
- BS, MS, or PharmD with at least 8 years of increasing responsibility in regulatory affairs; Advanced degree, RAC, or education in a scientific field strongly preferred
- Experience with rare diseases
We are seeking highly-motivated individuals with a track record of success. Critical characteristics include:
- Proven patient-centric focus and decision making
- Build strong, open and collaborative working relationships with both internal and external stakeholders and matrixed project teams
- Entrepreneurial spirit, ownership mentality, and a commitment to excellence
- Proven strategist that is results-oriented with a strong work ethic and ability to complete projects with minimal oversight
- Track record of defining various regulatory strategies and pathways followed by successful IND, CTA, NDA/MAA, and/or BLA submissions and/or health authority interactions based on patient and business priorities
- Ability to blend analytical and critical-thinking skills to enable data-driven, strategically oriented leadership and review of regulatory documents
- Knowledge of ICH, FDA and EMA regulations and guidances
- Excellent organizational skills and ability to work on multiple projects with tight timelines
- Excellent verbal and written communication skills
Enzyvant is committed to maintaining a safe and productive workplace and work experience for our team members. As part of these ongoing efforts, to the extend permitted by applicable law, Enzyvant requires all employees to be fully vaccinated against COVID-19, and this position requires that you be fully vaccinated against COVID-19 prior to your start date, as a condition of employment. If you are unable to be vaccinated, we will consider requests for reasonable accommodations in accordance with applicable legal requirements.