Position Overview:The Senior Director of Regulatory Affairs will identify, review and anticipate emerging regulatory issuesand oversee global regulatory submissions in compliance with applicable regulations.The Senior Director will develop and implement regulatory strategies for an investigational cellular therapyregulated as a biologic/medical device in accord with 1) FDA drug/biologic and medical device regulationsand 2) European human medicines/AdvancedTherapy Medicinal Product (ATMP) regulations and theEuropean Medical Device Directives.This role will also establish effective dialogue with U.S. and International regulatory authorities, direct theplanning and preparation of regulatory submissions, including license applications, for the company’sproducts and facilitate timely product registrations and regulatory approvals. The Senior Director willfacilitate cross-functional communication regarding key regulatory filings and provide guidance to anddevelop regulatory staff.Essential Duties and Responsibilities include, but are not limited to:
*Executing global regulatory health authority strategy for new product development
*Executing global regulatory health authority strategy for combinationdrug/device product licensure
*Leading project teams for key regulatory filings to support new product development
*Educating cross-functional teams on purpose and scope of proposed or planned regulatorysubmissions to drive new product development
*Providingoversight in taking innovative ideas from proof of concept through regulatory strategy,including product development, manufacturing, filing and approval, and commercial operations
*Monitoring the US and international regulatory environments, and provide executive managementwith assessments of the impact of new and changing regulations
*Regulatory functions including planning and filing of documentation with domestic and internationalregulatory agencies
*Obtaining/generating information to be submitted toregulatory authorities and prepares requiredregulatory submissions
*Acting as liaison with appropriate local, national and international regulatory authorities
*Collaborating with the Quality organization in driving compliance activities related to FDA and ISOregulations, and quality system standards activities
*Leading relevant project planning and review meetings; conducts the final company documentreview and corrections
*Identifying and ensuring the establishment and monitoring schedules for submissiondocumentation, review of documentation, protocols and reports received; prepares additionalwritten materials needed
*Coordinating the preparation of 510(k) Premarket Notifications, IDEs, PMAs, CTAs, IMPDs, DesignDossiers, Technical Files and other International RegistrationsRevised.
*Preparing responses to FDA letters, supplements, and amendments; participates in FDA inspectionsand presentations as required
*Provide oversight and direction to regulatory consultants/vendors to ensure completion ofdeliverablesand appropriate local VTL sponsorship, if applicable
*Writing department SOPs and implementing training programs for direct reports and otherfunctional groups to assure awareness of all requirements and maintain compliance with all currentregulation
*Participating in the preparation of the department’s budget; ensures that the department operateswithin capital and expense budget guidelines
*Maintaining oversight of pharmacovigilance and product labeling activities
*Reviewing product complaints for reporting as required by relevant agencies
*Performing all other related duties as directed by management
*Developing guidance for internal staffPosition Requirements:Education and Experience:
*Ph.D. with 5-7 years related experience; Master’s degree with 8 to 10 years related experience;Bachelor’s degree with 10 to 12 years of related experience, and/or equivalent combination ofeducation and experience, in preparing regulatory submissions fordevice AND drug or biologicproducts. Degree preferably in science or other technically related field or equivalent. RegulatoryAffairs Certification (RAC) preferred.
*Proven ability to prepare and submit documents to global health authorities, includingBiologicsLicense Applications (BLAs) or New Drug Applications (NDAs), Marketing Authorization Applications(MAA), Investigational New Drug Applications (INDs), and Clinical Trial Applications (CTAs).
*Demonstrate an excellent understanding of FDA and international regulatory requirements.
*Must have experience working with FDA locally and nationally.
*Strong writing, project management and communication skills
*Proven ability to develop and manage staff