The Senior Director of Regulatory Affairs will be responsible for developing regulatory strategies, leading Agency interactions, and preparing regulatory submissions for Cambrian’s portfolio of projects. They will work with Cambrian’s R&D and Clinical Development teams to develop regulatory strategies and plans that align with company goals and to leverage an external CRO network to deliver high quality submissions. This individual will be responsible for staying abreast of changes in the global regulatory environment and assessing and communicating the impact on the Cambrian portfolio.
- Provides strategic regulatory direction on projects including developing the overall regulatory plan, advising on regulatory requirements for development plans, study designs and marketing approval, conducting risk assessments, and managing critical issues and Health Authority interactions.
- Leads the successful implementation and execution of regulatory plans to support project approval and commercialization.
- Identifies, manages and oversees a network of Regulatory CRO partners which meet the needs of the portfolio
- Harnesses knowledge of US, EU and ICH regulatory requirements to strategically and operationally resolve regulatory issues impacting development programs to ensure business goals are met.
- Builds partnerships with key senior stakeholders from other functions to ensure that strategic business goals are met through sharing of knowledge, expertise and provision of appropriate resources.
- Liaises and influences US FDA, EMA, and other regulatory agencies as needed for all aspects pertaining to drug development including novel regulatory pathways, resolution of key regulatory issues and to expedite progression of projects.
- Takes a hands-on approach in leading the completion of IND/CTA, NDA/BLA/MAA, and other global submission documents.
- Serves as a subject matter expert on relevant global regulations, stays abreast of changes in the global regulatory environment, and assesses impact of changes on business and product development projects.
- Proactively manages critical issues, taking leadership for regulatory contribution.
- Supports the development of relevant policies, processes, and SOPs.
- Provides regulatory due diligence assessments of new opportunities as required.
- Minimum MS, PhD or PharmD Degree with 10+ years regulatory experience in pharmaceutical industry.
- Extensive hands-on regulatory experience, including managing IND/CTA and BLA/MAA submissions,
- Extensive experience in interacting with Health Authorities especially the FDA.
- Experience in multiple disciplines (Clinical Quality, Nonclinical) is strongly preferred.
- Ability to develop and implement complex global regulatory strategies.
- Strong scientific foundation, including a strong understanding of the development of small molecules and ATMPs
- Practical understanding, interpretation, and application of relevant ICH, FDA and EMA guidelines and regulations.
- Excellent verbal and written communication skills; able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates issues to internal and external stakeholders, including Senior Management.
- Ability to develop creative solutions
- Ability to prioritize and handle multiple projects simultaneously.
Cambrian offers competitive compensation packages that are made up of base salary, bonus and equity:
- Salary: $200,000 - $225,000 offered to NYC employees, commensurate with relevant experience; salary range may vary depending on state of residence
- Bonus: up to 15% based on performance
- Equity: Employee stock options vesting over 4 years with 1-year cliff
In addition to being part of a brilliant team of collaborative innovators, you will also enjoy the following benefits as a member of the Cambrian team:
- 16 Company holidays and unlimited vacation policy
- Comprehensive medical, dental, and vision insurance with fully employer paid coverage options for employees
- 401K with pre-tax and Roth contribution options
- Employee Assistance Program to provide free, confidential support for all employees and their dependents through Optum’s Life and Work Well
- Flexible spending accounts and health savings account
- Adoption assistance
- Short & long term disability
- Basic life & AD&D insurance, as well as voluntary life insurance
Cambrian Biopharma is proud to be an equal employment opportunity and affirmative action employer. We celebrate diversity and do not discriminate based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training