Director, Regulatory Affairs

AboutCodera 

Coderais aTang Capital company that provides in-house end-to-end drug development for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates,acquires and finances companies that develop and commercialize pharmaceutical products. 

Position Summary 

The Director, RegulatoryAffairswill support the development and execution of domestic and international regulatory strategy for Codera. This position involves planning,preparing,authoring and/or reviewing documents for inclusion inregulatory submissions, including medical writingand/or technicaldeliverables. The Director, RegulatoryAffairsis responsible forensuring documentation is clear andaccurate,complies with regulatory requirements, conforms tocompany qualitystandards and is completed on time, with proper archiving,publishing and management of content in applicable information systems. This position proactivelyidentifies potential issues that mayimpact submission timelines and drives process efficiencies to enhance strategic and operational effectiveness.  

Essential Duties and Responsibilities 

• Provide regulatory strategy advice and supportthedevelopment 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,authorand/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 assupporting 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 areaccurate,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 foridentified risks  

• Collaborate with vendors who support regulatory operations-related tasks  

• Assist with developing andmaintaining 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 

Qualifications 

• Bachelor’s Degreerequired 

• Master’s Degree in a life sciences discipline preferred
   

• Minimum7years of progressive experience in drug development and regulatory affairs and/or operationsrequired
   

• 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 useclear language to explain complex ideas 

• Possess a willingness and ability to work hands-on and witha high level of detail-orientation, in a fast-paced, entrepreneurial environment  

• Strategic agility, strong critical and logical thinking with ability to analyze problems 

• Ability toestablish and maintain collaborative working relationships with internal and externalstakeholders 

The job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required. They may change, or new ones may be assigned at any time with or without notice. 

The estimated annual base salary for this position is $185,000 - $230,000, commensurate with experience and skills. 

This role may be eligible for discretionary bonuses and other incentive programs. 

Codera provides a comprehensive benefits package designed to support employees’ physical, mental and financial health and include employer sponsored insurance plans including medical, dental and vision coverage; generous paid time off; retirement plan options and additional wellness and professional development programs 

Codera provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to 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. 

Codera participate in E‑Verify. All newly hired employees are required to complete the E‑Verify process as part of their employment eligibility verification.