Codera, LLC · 1 day ago
Director, Regulatory Affairs
San Diego, CA
Full-time
Onsite
Director/Executive
7+ years expCodera, LLC is a life-sciences focused investment company that provides in-house end-to-end drug development for its portfolio companies. The Director, Regulatory Affairs will support the development and execution of domestic and international regulatory strategy, ensuring compliance with regulatory requirements and quality standards while managing documentation and submission timelines.
Biotechnology
Responsibilities
Provide regulatory strategy advice and support the development and execution of regulatory strategies and plans
Ensure regulatory milestones are met to support approval strategies and overall business goals of the company
Plan, prepare and/or review submissions to regulatory authorities including FDA, EMA and other regulatory authorities to support the conduct of clinical trials and approval of marketing applications (e.g., IND, CTA, NDA/BLA, MAA)
Plan, author and/or review nonclinical and clinical study documents, including but not limited to: Clinical Study Protocols, Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), nonclinical and clinical summaries and scientific publications
Plan, author and/or review chemistry, manufacturing and controls (CMC) documents, including but not limited to: CMC sections of regulatory applications as well as supporting records summarizing manufacturing process development and validation, analytical method development and validation, comparability study protocols and reports, stability study protocols and reports and justification of shelf-life /expiry dating
Ensure that regulatory documents are accurate, complete and verifiable and confirm compliance with regulatory requirements and conformance to the company quality standards
Track progress of regulatory deliverables against timelines, proactively communicate progress and issues to key stakeholders and support development of proactive mitigation plans for identified risks
Collaborate with vendors who support regulatory operations-related tasks
Assist with developing and maintaining regulatory document processing and regulatory submission publishing standards and procedures
Identify and communicate regulatory system enhancement needs or technical issues
Assist with regulatory inspection activities, as necessary
Qualification
Required
Bachelor's Degree required
Minimum 7 years of progressive experience in drug development and regulatory affairs and/or operations required
Must have experience with regulatory submission documents including documents required for IND, CTA, NDA/BLA, MAA, and other related submissions
Direct experience in interactions with health authorities and performing country and region-specific submissions
Outstanding written and verbal communication skills, including the ability to use clear language to explain complex ideas
Possess a willingness and ability to work hands-on and with a high level of detail-orientation, in a fast-paced, entrepreneurial environment
Strategic agility, strong critical and logical thinking with ability to analyze problems
Ability to establish and maintain collaborative working relationships with internal and external stakeholders
Preferred
Master's Degree in a life sciences discipline preferred
Company
Codera, LLC
Codera is a Tang Capital company that provides in-house end-to-end drug development capabilities for its portfolio companies.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase