Description:
Fortvita is seeking a dynamic and experienced Senior Director / Director Regulatory CMC to lead regulatory CMC strategies for clinical development through commercialization. The ideal candidate has experience in large molecules product development, regulatory CMC leadership, and global filing experience. The person will work in a matrix environment and lead authoring and reviewing of documents required for global regulatory submissions, in compliance with applicable regulations. This role is a hybrid model located in Palo Alto, CA.
Responsibilities
- Provide strategic CMC regulatory leadership and expertise to develop and execute regulatory strategies for global development and registration.
- Identify and communicate regulatory risks and facilitate risk mitigation strategies.
- Leads health authority interactions for CMC specific issues.
- Leads the development, writing, reviewing, and editing of CMC related technical data for inclusion in Module 3 of the common technical document (CTD). This will include information from standard operating procedures (SOPs), batch records, stability protocols, manufacturing process development, validation reports, etc for the preparation of INDs, BLAs, IMPD sections, related Module 2 summaries (QOS), briefing documents, and any other regulatory submission documents needed to support regulatory meetings, marketing applications, and life cycle management.
- Leads and manages CMC regulatory changes throughout the product life cycle.
- Performs reviews of documents prepared by other team members for completeness, accuracy, structure and grammar.
- Interprets and analyzes data related to product characterization, manufacturing process, product and process control, analytical tests, and stability while interpreting and analyzing applicable tables, listings, figures.
- Attends cross-functional meetings and works closely with process development, manufacturing, analytical, quality, and regulatory affairs team
- members to communicate document-specific timelines to ensure deliverables are completed on-time.
- Other duties as assigned
Qualifications
- A minimum of a Master’s degree in life sciences. PhD or equivalent is a plus
- Eight or more years of industry (Pharmaceutical, Mabs, ADC) experience.
- Prior work experience with US FDA or EMA is a big plus
- In depth knowledge of US and ex-US regulations and filing requirements
- Thorough understanding of international guidelines (ICH, cGCP) and regulations
- Excellent verbal and written communication skills and the ability to interact professionally with a diverse group of stakeholders, senior managers, and subject matter experts.
- Strong analytical, project management skills.
- Able to follow directions and be accountable for work assigned.
- Able to work independently, multi-task, and prioritize workload.
- Must have a team attitude and work in a matrix environment
- Experience planning for and participating in Health Authority meetings.
- Demonstrated ability to assess and manage risk in a highly regulated environment.
- Demonstrated strong written, spoken and presentation communication skills.
- Demonstrated leadership behaviors and negotiation and influence skills.
- Demonstrated attention to detail.
- Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.