The successful candidate will be responsible for leading and managing the regulatory affairs within CMC function. This includes developing and leading regulatory CMC strategies and activities for a complex cell therapy product on a global basis. The successful candidate will ensure that all CMC regulatory goals are clearly defined and they align with current industry standards and regulatory requirements. This role will also provide significant input on applicable regulatory affairs processes, procedures, and tools to facilitate effective execution by the regulatory function across the organization. This individual must be highly skilled and provide expertise in CMC agency interactions and developing regional regulatory CMC strategies. In addition, the position assists corporate senior management in understanding CMC Regulatory strategies/processes while developing corporate objectives and, importantly, understanding the impact of decisions across therapeutic areas. Familiarity with GMP Quality, CMC development and exposure to clinical regulatory strategy is highly desired. (***For the potential candidate at VP level direct report possibilities)
Responsibilities- Develop the CMC regulatory strategies and manage related regulatory activities. Work with the Pharmaceutical Development team to prepare project plans and timelines for pipeline of products, including coordination and oversight of all types of regulatory CMC submissions including type B, C, D meetings.
- Supervises/manages others to ensure that all reporting requirements and other commitments are met with respect to INDs, BLAs, CTA, MAAs, etc. Prep and author updates in conjunctions with the cross-functional teams.
- Advise the global regulatory phase-appropriate compliance of gene and cell therapy pipeline of products including the evaluation of CMC related change controls, the strategic assessment of process and product comparability, their regulatory impact and implementation.
- Lead the preparation, authoring, review and filing of CMC sections of regulatory submissions with the highest quality and robust interactions with regulatory agencies.
- Maintain a centralized archive for tracking and monitoring the status of regulatory CMC commitments and agency reporting obligations. Create and issue status reports and other communication to the organization.
- Provide strategic CMC regulatory support, guidance and expertise, and act as the Regulatory Affairs primary point of contact to cross-functional teams including Pharmaceutical Development, Quality Assurance, Quality Control, contract organizations and consultants. Ensure that all applicable regulatory requirements/options and associated risks are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines.
- Work across functional groups in identifying issues that may delay timelines, providing solutions to difficult technical/functional issues associated with specific projects, as well as support the resolution of issues that arise.
- Ensure the regulatory conformance of technical documentation including technical transfer protocols, validation protocols, technical reports, manufacturing and labeling information.
- Provide guidance and advice on regulatory CMC environments and trends; provide assessment of the impact of new and changing regulations/requirements.
- Author, review, and maintain regulatory and scientific documents to support business and submission needs.
- Track and report on Medical Writing and Regulatory Operations projects, timelines, and key milestones to support timely execution.
Qualifications- BA/BS in a scientific field of study with 10 years + of relevant experience working in Regulatory in the pharmaceutical/ biotech industry.
- Strong knowledge, experience and leadership in interpretation of regulations and guidelines related to biologics drug development.
- Experience in the gene or cell therapy area is preferred.
- Proven ability to analyze and organize information logically.
- In depth understanding and application of industry standards and international regulations and guidelines.
- Experience in communicating regulatory strategy, submission documents and plans both internally and externally.
- The ability to coordinate and prioritize multiple projects in a fast-paced, deadline driven start-up environment.
- Strong collaboration, team work, organizational skills at attention to detail
- Excellent written and verbal communication skills.
- Travel 20%
Salary and Benefits- Compensation for this role includes base salary, annual target bonus and equity
- The base salary range for this role is $245,000-285,000. Starting pay is determined by multiple job-related factors including a candidate's skills, education and experience level, benchmark, and internal parity
- Significant growth opportunity as the company expands
- Empathetic, supportive and collaborative colleagues and work environments
