European Union Regulatory Affairs, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
The Senior Director of Regulatory Affairs is responsible leading the overall regulatory strategy for Adverum’s clinical development programs, focusing on the program and corporate goals. This individual will be the regulatory lead internally and externally with program oversight and assist in developing procedures to ensure regulatory compliance. The Senior Director will be responsible for developing, implementing, and advising on global regulatory strategies through all phases of clinical development success of Adverum’s development programs. This individual will manage regulatory aspects Adverum’s development products. The Senior Director will provide leadership and strategic regulatory oversight for designated projects ensuring that the latest requirements, standards and trends within the company and industry are met. The individual has departmental and core team influence and/or oversight and acts as an advisor/liaison to senior management in order to plan, evaluate, and recommend regulatory strategies for his/her projects. This individual will interface with Health Authorities and business partners, as appropriate, in regards to development, regulatory, and registration strategies. He/she may also provide line management, mentoring and people development, and performance management as well as support development and implementation of department policies and procedures.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
Provide high level strategic and operational regulatory direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies in domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions
Use extensive knowledge of US, EU, and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development programs and regulatory issues to support corporate goals
Provide direction for effective execution of the developed regulatory strategies, tactics and implementation of all regulatory aspects of assigned program, and responsible for the timely development and submission of regulatory documentation
Provide guidance on content and provide review and approval of regulatory submissions including requests for Designation, Meeting Background Packages, INDs and CTAs
Build partnerships within a matrixed team-oriented structure with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise, and the provision of appropriate resource(s)
Work in collaboration with the Vice President of RA, to inform/advise on the gene therapy program requirements and timelines to support corporate goals
Maintain regulatory expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment and regulatory precedence.
ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
Must be willing to work in a smaller organization and support other duties, as assigned
Demonstrate excellent communication and influencing skills internally and externally at all levels of the organization
Strong organizational, communication, negotiation and interpersonal skills is required
Having an eye for detail is required and ability to multi-task effectively
Work on special projects, as requested
Exhibit strong organizational leadership and values to influence the success of the Regulatory group.
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
BS Degree is required; an advanced degree (Masters, PharmD, PhD) is an added bonus
Minimum 12 years experience in Regulatory Affairs
Expert knowledge and experience in gene therapy highly desirable
Specialty pharmaceuticals or rare & orphan disease experience are both beneficial
Experience as lead regulatory strategist
Comprehensive knowledge of applicable regulations
Experience in requirements for IND/CTA, BLA/MAA, product lifecycle management, interactions with Health Authorities
Experience interacting with external business partners and Health Authorities
Proven ability to work successfully and influence within a cross-functional team/partnership environment with a high level of professionalism
Business travel up to 10-15% travel.
Internal Number: 246
About Adverum Biotechnologies
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum has collaboration agreements with Regeneron Pharmaceuticals to research, develop, and commercialize gene therapy products for ophthalmic diseases and Editas Medicine to explore the delivery of genome editing medicines for the treatment of inherited retinal diseases. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.