At DiCE Molecules, we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms.
In this role the Associate Director of Regulatory Affairs will develop, implement, and manage regulatory activities within DiCE and with external vendors to support the development DiCE’s portfolio of products. The Associate Director of Regulatory will ensure sound regulatory strategy is developed in collaboration with the cross-functional team and clearly communicated to management. Additionally, this role will ensure that regulatory submissions are maintained with the highest compliance, integrity, quality and regulatory standards to meet program and company goals. This position reports to Vice President Regulatory Affairs and is based in South San Francisco with potential for flexible work arrangements.
Key Responsibilities:
Responsible for developing global regulatory strategies for assigned projects in coordination with the VP of regulatory affairs through all phases of clinical development in line with corporate objectives, timelines and budgetsRepresent Regulatory Affairs on project teams and closely collaborate with multidisciplinary teams to identify submission requirements and define timelines to ensure on-time delivery of high-quality, compliant, accurate and complete regulatory submissionsMust possess and maintain an advanced level of understanding and awareness of existing and emerging regulatory regulations and guidelines and be able to interpret, apply and effectively communicate those that are applicable to the company’s projects to both senior and peer managementProactively identify potential regulatory issues and risks and provide solutions to keep assigned programs on time, while maintaining the highest qualityEnsure compliance with corporate policies and procedures, as well as health authority laws and regulationsSupport regulatory and compliance initiatives including the development, implementation and maintenance of company systems, processes, policies, and proceduresContribute to and participate in internal and external education and training activitiesThis position may manage the activities of other regulatory affairs staff or contract regulatory support
Preferred Experience and Education:
Bachelor’s degree in a scientific field preferredMinimum 8 years in the pharmaceutical or biotech industry experience of direct experience in the pharmaceutical industry managing regulatory strategy related to product development and commercializationA background in immunology and small molecule products is highly desirableExperience with CMC and nonclinical requirements for INDs preferredStrong leadership and interpersonal skills with reputation for collaboration with colleaguesMust be willing to be hands-on, contributing to submissions and timeline managementExcellent attention to detail with the ability to detect and correct errors and/or inconsistencies in a variety of documentsPrior experience collaborating with vendors and direct reports, including mentoring and career developmentExpert understanding of the content and submission requirements for US and international clinical trial applications (INDs, CTAs), and marketing applications (NDAs, MAAs) as well as amendments and supplements to submissionsExperience leading, writing and submitting major regulatory submissions such as IND, CTA, NDA/MAA as well as submissions supporting these applications including but not limited to designation requests, health authority responses, and annual updates through all phases of clinical developmentDirect experience organizing and preparing for Health Authority meetings, including meeting requests, briefing documents, and team engagementAbility to think creatively in order to problem-solve and make decisions on complex issues, often in across-functional team settingAbility to work independently and prioritize with minimal daily instruction with proven ability to manage multiple projects while maintaining qualityExcellent communication and time-management ability; strong organizational and planning skills as well as written and verbal communicationStrong computer skills including MSOffice (Word, Excel, PowerPoint, SharePoint); experience with eCTD format and electronic publishing requirements a plus
DISCLAIMER
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.
