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Regulatory Affairs Director
1 week ago
Overview
Codera, a leading life sciences-focused investment company, is seeking a highly skilled Regulatory Affairs Director to support the development and execution of domestic and international regulatory strategy.
Key Responsibilities
- Regulatory Strategy Development: Provide strategic advice and support the development and execution of regulatory strategies and plans to ensure compliance with regulatory requirements.
- Regulatory Milestone Management: Ensure regulatory milestones are met to support approval strategies and overall business goals of the company.
- Submission Planning and Review: 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.
- Document Authoring and Review: Plan, author, and/or review nonclinical and clinical study documents, including clinical study protocols, clinical study reports, investigator's brochures, nonclinical and clinical summaries, and scientific publications.
- CMC Document Management: Plan, author, and/or review chemistry, manufacturing, and controls (CMC) documents, including CMC sections of regulatory applications and supporting records summarizing manufacturing process development and validation.
- Regulatory Document Verification: Ensure that regulatory documents are accurate, complete, and verifiable and confirm compliance with regulatory requirements and conformance to the company quality standards.
- Progress Tracking and Communication: 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.
- Collaboration and Vendor Management: Collaborate with vendors who support regulatory operations-related tasks and assist with developing and maintaining regulatory document processing and regulatory submission publishing standards and procedures.
- Regulatory System Enhancement and Inspection Support: Identify and communicate regulatory system enhancement needs or technical issues and assist with regulatory inspection activities, as necessary.
Qualifications
- Bachelor's Degree required
- Master's Degree in a life sciences discipline preferred
- 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
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