Head of Regulatory Compliance (CD20-242)
Catalyst Biosciences (Catalyst, CBIO) is seeking an accomplished individual to serve as the Head of Regulatory Compliance reporting to the Senior Vice President, Regulatory Affairs. The successful candidate will be a proven leader who will work closely with the company’s leadership team and company staff to develop and advance Catalyst Biosciences’ pipeline programs consistent with the company’s vision and in a manner compliant to regulations.
The Head of Regulatory Compliance is a hands-on position responsible for driving the company’s Regulatory Compliance function with a focus on Good Clinical Practice (GCP), Good Laboratory Practice (GLP), product labeling, and product data reporting. This person will interact with internal departments to build and direct the corporation’s Regulatory Compliance initiatives. In addition, this person will ensure adherence to regulatory requirements for activities performed by internal staff, external vendors, and clinical trial sites. This person will also represent the company’s Regulatory Compliance function during interactions with health authorities.
ABOUT CATALYST BIOSCIENCES
Catalyst is a clinical-stage biopharmaceutical company focused on developing novel medicines to address important unmet medical needs in patients with rare bleeding and complement related disorders. Catalyst currently has compounds in discovery and development phases that span the value chain from the early discovery stage to late stage clinical trials with the intent of commercialization.
- Accountable for developing, articulating, and gaining alignment across the organization on the necessary regulatory compliance policies, processes, and procedures that support advancement of the company’s pipeline
- Develop and direct an internal regulatory compliance program that ensures a high level of adherence to regulation inclusive of a continual improvement program
- Actively collaborate with teams and functional areas to ensure clinical/nonclinical studies are conducted and data are reported compliant to regulatory requirements
- Lead and direct the development and implementation of risk-based Clinical Quality Assurance Plans
- Provide insight for clinical/nonclinical assay validations
- In collaboration with Quality, ensure training of staff to applicable regulations
- Ensure product labeling and data disclosures are compliant to regulatory requirement
- Provide strategic guidance for key clinical document control systems
- Direct the activities of subordinates to establish and maintain a high level of excellence regarding adherence to regulatory requirements and scientific integrity
- In partnership with Quality, develop compliance monitoring process to generate regulatory compliance metrics and trending analyses for status reports to the company’s leadership team
- Lead, manage, and ensure a state of inspection readiness on regulatory compliance matters
- Coordinate with internal functional areas and external vendors/clinical sites to represent the company during interactions with health authorities
- Actively support the company’s cultural initiatives
- Minimum of 10 years of building and managing a regulatory compliance function in biotechnology with an emphasis on an outsourcing model
- BS degree in Life Sciences preferred
- Comprehensive understanding of GLP/GLP/Labeling/Data Disclosure regulations applicable to pharmaceutical development and commercialization
- Proven track record in building and managing a high performing quality team
- Must be a dynamic leader with outstanding communication skills and an ability to effectively direct subordinates
- Demonstrated strengths in problem solving, strategic planning, and working collaboratively
Thank you for your interest in Catalyst Biosciences! You may apply for this position by sending your CV/resume to firstname.lastname@example.org, referencing requisition number (CD20-242) in the subject line.