Associate Director of Regulatory Affairs
Location: Redwood City, CA
- Rezolute is a clinical-stage biopharmaceutical company developing novel therapies for diseases caused by chronic glucose imbalance.
- Rezolute has initiated a global Phase 2b trial in Europe for their lead clinical asset, RZ358, which is a potential treatment for Congenital hyperinsulinism (CHI), an ultra-rare pediatric genetic disorder characterized by excessive production of insulin by the pancreas.
- The company’s second clinical-stage asset, currently in Phase 1, RZ402, is a selective and potent plasma kallikrein inhibitor (PKI) being developed as a potential oral therapy for the chronic treatment of diabetic macular edema (DME)
- Rezolute has received orphan drug designation in the United States and European Union as well as a rare pediatric disease designation, for RZ358, enabling eligibility for a priority review voucher.
- More information can be found at rezolutebio.com
The Associate Director of Regulatory Affairs is an experienced professional who will formulate and implement regulatory strategy, provide guidance to program teams and sub-teams, resolve complex issues related to assigned projects, and assure compliance with timelines and milestones to meet business needs.
- Clearly communicate regulatory requirements to ensure regulatory deliverables are managed and completed according to agreed timelines; provide sound regulatory recommendations which may have long-term impact
- As part of project team, assess risks and provide team with guidance on implications and impacts to program, resources, and timeline; develop content message points and contingency plans
- Represent regulatory viewpoint during discussions, team meetings, and document reviews; may participate in due diligence assessments in collaboration with business development
- Collaborate with senior management on relevant long-term regulatory strategies to ensure effective achievement of regulatory/business objectives
- Assess CMC regulatory strategy for proposed changes, new development efforts, and other related activities emphasizing requirements and working to coordinate timelines with other project activities
- Actively manage department policies and procedures including development and implementation of SOPs and Work Instructions to ensure compliance with requirements and improved efficiency
- Efficiently develop and coordinate complex and high-quality regulatory submissions such as briefing documents, INDs, CTAs, supplements/amendments, and responses to agency questions
- Plan and manage routine submissions such as annual reports and investigator documents while also handling urgent submissions as needed
- Manage preparation for Health Authority interactions including coaching team, assessing potential alternate positions, and working to ensure readiness for optimum outcomes from agency interactions
- Bachelor’s degree required; understanding of genetic disorders, rare diseases, and/or pediatric clinical studies desired
- Excellent knowledge of overall drug development process from discovery to marketed products with progressively responsible roles in regulatory, full understanding of ethical conduct and importance of compliance
- Proven effectiveness leading regulatory activities and familiarity with all phases of clinical development; capacity to develop and maintain excellent working relationships with internal collaborators, business partners, and regulatory authorities
- Knowledge of US and EU regulations governing pharmaceutical development and understanding of relevant guidance documents such as FDA, ICH, EMA and principles of GCP and GMP; familiarity with rare disease and pediatric development desired
- Small and large molecule experience is a plus, including involvement in global development planning with clear understanding of necessary submissions to support clinical trials and related regulatory milestone activities during development (e.g., EPO2 meetings, Scientific Advice meetings, PIP development, etc.)
- Experience leading and/or actively managing strategic submissions such as Orphan Drug, Fast Track, and Breakthrough Therapy designations; sound decision making, negotiation, and problem-solving skills required
- Hands-on experience with submission development including key documents to support INDs, CTAs, and BLA/NDA (e.g., developing content, planning and timeline tracking, and final review/approval, eCTD review)
- Strong project management skills to establish priorities, manage multiple deliverables, and track key tasks across functions to ensure goals and timelines are met
- Excellent proficiency with MS Office software including document versioning, styles/templates, and publishing concepts for Acrobat documents; experienced in internet research (e.g., competitive products, labeling, regulation/guidance); familiarity with principles of document management, archiving, and eCTD systems
Preferred Experience, Special Skills and Knowledge
- Strategic agility, ability to work well under pressure, and strong attention to detail with commitment to quality in all areas of responsibility
- Excellent verbal and written communication skills with ability to interact with senior management, regulatory authorities, and business partners as needed to advance program; ability to present strategy, summarize key points, and determine decision path
- Able to work effectively in both a collaborative and an independent manner in a start-up environment; must interact in proactive, honest, and productive manner while focusing on milestones, compliance, and key decisions needed to advance program
Interested and qualified candidates should send their resume to email@example.com to the attention of Melissa Quinn.