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Head of Regulatory and Quality - San Diego, United States - Candid Therapeutics
Description
Company Overview:
Candid Therapeutics is a growing biotechnology company based in San Diego, California, dedicated to improving patients lives by advancing novel therapies to address unmet medical needs
Position Overview:
As the Head of Regulatory and Quality, you will be a key member of our executive leadership team, responsible for providing strategic direction and oversight for all regulatory and quality functions within the company.
Your role will be pivotal in ensuring compliance with regulatory requirements, maintaining high-quality standards, and driving continuous improvement initiatives across our product portfolio.
Key Responsibilities:
Regulatory Strategy and Compliance:
Develop and implement regulatory strategies to support the successful registration, approval, and commercialization of our products in domestic and international markets.
Stay abreast of evolving regulatory requirements, guidelines, and trends to proactively assess potential impacts on our business operations. Establish and maintain strong relationships with regulatory agencies and oversee interactions, including submissions, inspections, and audits.Quality Management Systems:
Lead the development, implementation, and maintenance of comprehensive Quality Management Systems (QMS) to ensure compliance with relevant standards, regulations, and industry best practices.
Drive a culture of quality throughout the organization by promoting adherence to QMS procedures and fostering continuous improvement initiatives. Oversee the management of quality assurance, quality control, and quality engineering functions to maintain product quality and safety standards.Regulatory Affairs Operations:
Direct the preparation, review, and submission of regulatory filings, including INDs, BLAs, NDAs, MAAs, and variations, ensuring accuracy, completeness, and timeliness.
Provide guidance and support to cross-functional teams on regulatory requirements for product development, clinical trials, manufacturing, and post-market activities.Manage regulatory intelligence activities to monitor changes in regulations, competitor activities, and industry trends, and assess their impact on our regulatory strategies.
Quality Assurance and Compliance:
Lead the development and implementation of quality assurance programs, policies, and procedures to ensure compliance with applicable regulations and standards, such as cGMP, ISO, and ICH guidelines.
Conduct internal audits and assessments to evaluate compliance with QMS requirements and identify opportunities for improvement. Coordinate external audits and inspections by regulatory agencies or third-party auditors, ensuring readiness and facilitating successful outcomes.Qualifications:
Bachelor's degree in a relevant scientific or technical discipline; advanced degree (e.g., MSc, PhD, JD) preferred.
Extensive experience (15+ years) in regulatory affairs and quality management within the biotechnology or pharmaceutical industry, with a proven track record of success in regulatory submissions, approvals, and compliance.
Strong leadership skills with the ability to inspire and motivate cross-functional teams, drive strategic initiatives, and foster a culture of compliance and quality excellence.
Excellent knowledge of global regulatory requirements and guidelines, including FDA, EMA, and other international regulatory agencies.Exceptional communication, negotiation, and interpersonal skills, with the ability to effectively collaborate with internal stakeholders, external partners, and regulatory authorities.
Strategic thinker with the ability to anticipate and mitigate regulatory risks, solve complex problems, and make sound decisions in a dynamic and fast-paced environment.
How to Apply:
To apply, please submit your resume to .Candid Therapeutics is an equal opportunity employer and is committed to diversity in the workplace.
Job Type:
Full-timePay: $250, $350,000.00 per yearBenefits:Dental insuranceHealth insurancePaid time offVision insuranceExperience level:10 yearsExperience:FDA regulations: 1 year (Preferred)
Ability to Commute:
San Diego, CA (Required)
Ability to Relocate:
San Diego, CA: Relocate before starting work (Required)
Work Location:
In person#J-18808-Ljbffr
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