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 CMC Regulatory will provide CMC Regulatory leadership and ensure sound regulatory strategy is developed in collaboration with cross-functional Project Teams and CMC functional teams to support the development of DiCE’s portfolio of products. Additionally, this role will ensure that regulatory CMC 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.
- Responsible for leading regulatory CMC activities for assigned project(s) in line with FDA/EMA/ICH requirements, regional requirements and company policies and procedures.
- Serve as a liaison between the regulatory function and the project teams regarding regulatory CMC issues
- Responsible for ensuring the development and execution of an integrated CMC regulatory strategy to support development programs, new drug applications and change control implementation plans for small molecules in the Dice pipeline.
- Contribute to or lead the authoring, review, and approval of CMC submissions that are technically complex and may require interaction with departments outside of Regulatory Affairs CMC (eg. NDA/BLA, IND/IMPD, supplements and variations for US and other assigned territories).
- Responsible for interactions and contact with regulatory agencies to facilitate timely regulatory review and approval of applications and proposed CMC changes while maintaining regulatory compliance
- Evaluate manufacturing change controls, assessment of regulatory impact and support their implementation
- Work across all levels of company to communicate complex CMC regulatory issues and deliver updates on major CMC regulatory guidance.
- Lead the preparation of risk assessments for major global CMC regulatory issues as needed.
- Maintain current working knowledge of regional and global regulatory requirements, analyze current trends and anticipate changes in the regulatory requirements to adjust strategic plans as appropriate.
- Proactively identify potential regulatory issues and risks and provide solutions to keep assigned programs on time, while maintaining the highest quality
- Support regulatory and compliance initiatives including the development, implementation and maintenance of company systems, processes, policies, and procedures
- Contribute to and participate in internal and external education and training activities
- This position may manage the activities of other regulatory affairs staff or contract regulatory support
Preferred Experience and Education:
- Bachelor’s degree required, MS/PharmD preferred
- Minimum 8 years in the pharmaceutical or biotech industry with direct experience in the pharmaceutical industry managing small molecule CMC regulatory strategy related to product development and commercialization
- Experience with managing large CMC submissions (IMPD, IND) preferred
- Strong leadership and interpersonal skills with reputation for collaboration with colleagues
- Must be willing to be hands-on, contributing to submissions and timeline management
- Excellent attention to detail with the ability to detect and correct errors and/or inconsistencies in a variety of documents
- Prior experience collaborating with vendors and direct reports, including mentoring and career development
- Expert understanding of the CMC 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 submissions
- Experience 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 process changes, comparability plans, stability updates, health authority responses, and annual updates through all phases of clinical development
- Direct experience organizing and preparing CMC topics for Health Authority meetings, including meeting requests, briefing documents, and team engagement
- Ability to think creatively in order to problem-solve and make decisions on complex issues, often in a cross-functional team setting
- Ability to work independently and prioritize with minimal daily instruction with proven ability to manage multiple projects while maintaining quality
- Excellent communication and time-management ability; strong organizational and planning skills as well as written and verbal communication
- Strong computer skills including MS Office (Word, Excel, PowerPoint, SharePoint); experience with eCTD format and electronic publishing requirements a plus
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.