Associate Director/Director, Regulatory Affairs

About the job

At Syncopation Life Sciences, upending the status quo is in our DNA. We combine a deep understanding of CAR T resistance with a vision of transforming peoples’ lives through the development of next generation cell therapies that provide deeper and more durable responses to a growing number of patients.Syncopation is an exciting biotechnology company founded by Crystal Mackall and Robbie Majzner to develop next generation CAR T cell therapies designed to achieve superior efficacy by pre-empting important drivers of drug resistance. Our lead program includes a differentiated and clinically validated CD22 CAR that is in clinical development for patients with B-cell malignancies. To help move this and other programs forward, Syncopation has brought together a passionate and seasoned team to develop a focused portfolio strategy. Our team is based in San Mateo, California.

Join us to help make a difference.

Position Summary

Syncopation is hiring an Associate Director/Director, Regulatory Affairs to grow a global regulatory affairs function for our cell therapy portfolio.

This person will be responsible for development of US and rest of world regulatory strategy for Syncopation’s cell therapy pipeline and to represent Regulatory Affairs on project teams. The individual must have knowledge of regulatory requirements in major regions (US, EU) with responsibility to form a global strategy, including in Asia; Develops and maintains communications with FDA/EMA and coordinates interaction with other regulatory agencies worldwide.

The successful candidate will work closely with the chief medical officer to develop the long term global regulatory strategy and vision for Syncopation cell therapy products. This includes leading interactions with health authorities, leading and contributing to submission management activities, and creating fit for purpose regulatory function processes including appropriate build out of the regulatory team.

The role is based in San Mateo, CA but may also be suitable for a hybrid or remote work arrangement.

What You’ll Do at Syncopation

The Associate Director/Director, Regulatory Affairs will develop, implement, and execute across the following broad areas of responsibility:

  • Develops regulatory strategic plans for project teams. Works with project teams to resolve complex project issues. Supports team interactions and alignment with partner. Utilizes expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained. Represent IDEAYA before regulatory authorities.
  • Assists in the design and interpretation of results for Clinical Studies required for Regulatory Approvals.
  • Responsible for filing of IND/CTA, NDA/BLA/MAA submissions. Sets strategy for submissions of product registration documents to health authorities worldwide. Interacts with other line functions in the preparation, review, and completion of documents for regulatory submissions.
  • Responsible for keeping management team informed of regulatory status of programs and significant regulatory issues. Able to present and implement project related regulatory strategy with all Project Teams. Assures compliance with project team timelines and milestones.
  • Helps build the regulatory function, build, and maintain strong leadership capabilities at all levels within the regulatory team and support the professional development of regulatory team members. Developing and implementing cross site department policies, processes and SOPs.
  • Over time, manages a team in Regulatory Affairs & Regulatory Operations and has working knowledge of the Regulatory Operations function and submission logistics
  • Has working knowledge of regulatory issues that pertain to CMC
  • Ensure the successful on time delivery of high-quality submissions to global regulatory health authorities in alignment with both Syncopation and health authority standards.
  • Maintain current expertise in regulatory trends and operations

The Right Stuff

  • Preferred Qualifications:Graduate degree required, PhD, MD or Pharm D. degree preferred.
  • Minimum 7 years in biotech/pharma industry with 2+ years of managerial experience leading, coaching and developing a team of people.
  • Extensive regulatory experience with gaining approvals of NDAs, MAAs, BLAs and/or sBLAs. Experience with breakthrough designation, RMAT, Sakigake, PRIME, orphan designation and companion diagnostic submissions (IDE/PMA) is highly desirable
  • Experience with cell and gene therapy products/ complex biological products
  • Experience with hematology/oncology products and interacting with CBER
  • Experience in leading multidisciplinary teams
  • Relevant knowledge in CMC, clinical and nonclinical science
  • Knowledge expert regarding global regulatory submission standards and publishing best practices.
  • Knowledge expert regarding FDA regulations, ICH and global cell therapy product development guidelines
  • Experience with process design and improvement and with developing systems from the ground up.
  • Ability and interest in rolling up their sleeves to perform hands-on regulatory activities while simultaneously building the department to ensure successful scalability as the programs grow
  • Demonstrated proficiencies in leading successful health meetings and interactions
  • Ability to influence without direct authority
  • Independently motivated, excel at driving execution, detail oriented
  • Strong written and verbal communication skills
  • Understanding of clinical operations with the ability to implement well-designed experiments within a clinical trial environment
  • Proven experience in building a high performing team. You can recruit and develop top talent, motivate and empower a team, work cross-functionally, and delegate effectively.
  • Must be willing and available for periodic travel including domestic US and internationally as required.

EEO & Employment Eligibility

Syncopation Life Sciences, Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Syncopation Life Sciences, Inc. also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requires of applicable law.

Syncopation Life Sciences requires all new hires to be fully vaccinated against COVID-19 as of their start date.  This requirement is a condition of employment at Syncopation, and it applies regardless of whether the position is located at a Syncopation site or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.