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Associate Director, CMC Regulatory Affairs

Associate Director, CMC Regulatory Affairs

  • Full-Time
  • Associate Director
Location: 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 Pharma Co., Ltd.)

Description

The Regulatory Affairs team at Enzyvant takes pride in developing and executing innovative strategies designed to support the efficient development and commercialization of life-saving therapies. We are looking for an Associate Director of CMC Regulatory Affairs to join our team. The ideal candidate will be dedicated to excellence and high performance, passionate, innovative, and eager to work in a collaborative environment. A demonstrated track record of success in the pharmaceutical industry is expected; experience in the development or commercialization of biologics and advanced therapies is a plus. Importantly, we seek an aspiring professional with potential and desire to grow within the company.

The successful candidate will be an integral member of a small Regulatory team, and work closely with a cross-functional development team and external partners. This critical role will report to the Sr. Director, CMC Regulatory Affairs, and be instrumental to the growth and success of our department and company. Given the small company and dynamic nature of the work, the successful candidate must be agile and nimble, with an ability to maintain focus on efficiently advancing innovative medicines addressing rare and often fatal diseases.

 

Responsibilities

  • Author, review and compile CMC sections of regulatory submissions (BLA/MAA and IND/IMPD submissions, meeting packages, and annual reports) and ensure compliance with regulatory requirements.
  • Maintain development and post-marketing regulatory compliance by conducting global regulatory assessments of proposed changes to manufacturing processes and testing procedures.
  • Prepare accurate and timely responses to regulatory authority information requests.
  • Track regulatory commitments and deliverables while coordinating with internal and external staff to ensure timely, quality submissions.
  • Represent the Regulatory department in project meetings and provide guidance to project teams as appropriate, including guidance for development and life-cycle management strategies.
  • Communicate project updates and risks to senior management and stakeholders across the organization.
  • Maintain up-to-date knowledge of international and domestic regulatory requirements and best practices.
  • Advise and direct on the interpretation and implementation of regulations, guidelines, company procedures, and working practices.
  • Provide regulatory CMC assessment for business development opportunities to include other biologics and small molecules.
  • Other duties as necessary, including support for the Quality Department and company initiatives.

Qualifications

  • BS or MS in a scientific field (Chemistry, Biology or Engineering); advanced degree and/or education preferred
  • Minimum of 7 years of experience in the pharmaceutical industry
  • 5+ years of experience in a CMC or regulatory CMC function (biological products experience preferred)
  • Knowledge of FDA/EMA regulations, ICH guidance, and GMP regulations
  • Passion for science and an understanding of drug development and life cycle management concepts and interdependencies with the overall development process

Skills

  • Integrity, entrepreneurial spirit, ownership mentality, and a commitment to excellence
  • Strong organizational skills and ability to work on multiple projects with tight timelines
  • Excellent verbal and written communication skills
  • Strong interpersonal skills and desire to work with matrixed project teams
  • Ability to execute job duties with minimal oversight

Contact us for more information