Reporting directly to the VP of Regulatory Affairs (RA), the Director of RA will be responsible for providing US and global regulatory leadership in support of the development, registration, and life-cycle management of our innovative gene therapy programs.
The responsibilities include providing US and global regulatory leadership and direction for gene therapy products, including developing long and short-term planning of regulatory projects that align with the company's business plan, and developing strategies to ensure effective achievement of regulatory/business objectives. The individual will be responsible for staying current in the regulatory environment and assessing and communicating the impact of changes on business and product development.
The Director of RA will be an experienced and highly motivated professional who has developed regulatory strategy associated with all phases of drug development, including the coordination and preparation of document packages for regulatory submissions and leading cross functional teams. This individual will have a strong rapport and collaborative relationship with the US Food and Drug Administration (FDA) and other regulatory agencies worldwide.
Characteristics sought for a good cultural fit to the company include the ability to work collaboratively, strong project management skills, excellent planning and budgeting skills, ability to think strategically and act independently, a "hands on" approach in the implementation of an agreed-upon plan, nimble problem-solving skills, an innate sense of urgency, creative thinking about what is possible in execution, and general positivity.
Responsibilities
Provides US and global regulatory leadership in support of the development, registration, and life-cycle management of products.
Provides strategic regulatory direction including developing the global regulatory plan, advising on regulatory requirements for development plans, study designs and marketing approval, conducting risk assessments, and managing critical issues and health authority interactions.
Writing regulatory documents (e.g. new INDs, briefing book content, RMAT/PRIME Designation request, Priority Review Requests, ODD, Pediatric Investigational Plans); reviewing core documents to support IND/CTA, in conjunction with VP of RA as needed.
Foster positive relationships with FDA and other health authorities. Liaises and negotiates with health authorities as needed for all aspects pertaining to drug development including novel regulatory pathways for the company's gene therapy products, resolution of key regulatory issues and to expedite approvals of products.
Ensures the successful implementation and execution of regulatory plans.
Harnesses knowledge of FDA and ICH regulatory requirements to strategically and operationally resolve regulatory issues impacting development programs to ensure business goals are met.
Builds partnerships with key senior stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise and the provision of appropriate resources.
Takes a hands-on approach in leading the completion of IND/CTA and other global submission documents.
Serves as a subject matter expert on relevant regulations, stays abreast of changes in the regulatory environment, and assesses impact of changes on business and product development programs.
Proactively manages critical issues, taking leadership for regulatory contribution.
Qualifications
MS degree, advanced degree in a life science or related discipline preferred (e.g., PhD, PharmD, MSc, MBA).
A minimum of 10 years of regulatory affairs experience, ideally gained from a mix of both large and small companies.
5+ years of regulatory filing (IND/CTA/BLA/MAA) strategy preferred.
A prior track-record of successful regulatory delivery, with IND/CTA and NDA/BLA submission experience.
Experience working with cell and gene therapies and/or rare diseases is preferred. Other therapeutic areas will be considered if the individual has experience defining and designing novel regulatory pathways.
Extensive experience in interacting with global regulatory agencies (MHRA, TGA, EMA, Turkey, Canada, Japan).
Ability to develop and implement global regulatory strategies.
Practical understanding, interpretation, and application of relevant ICH and FDA guidelines and regulations.
Excellent verbal and written skills; able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates issues to internal and external stakeholders, including Senior Management.
Ability to think creatively and develop creative solutions.
Ability to prioritize and handle multiple projects simultaneously.
Sense of urgency and perseverance to achieve bringing curative therapies to patients.
iECURE is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.