As the Senior Director of Regulatory Affairs, you will architect and lead international regulatory strategy and execution to support Corcept’s international commercialization and expansion, starting with Europe. This role ensures all regional and local regulatory requirements are met in cooperation with Corcept functions responsible for clinical research, manufacturing, and commercialization. Staying attuned to the evolving regulatory environment, you will assess and communicate the impact of changes on business and product development programs. At times, you will directly represent Corcept with health authorities in Europe and elsewhere, as our expansion continues.

Responsibilities:

• Develop robust European regulatory plans, aligned with Corcept’s global strategy, that lead to commercialization in new countries 
• Provide regulatory guidance regarding European health authorities and interactions, including EMA 
• Contribute and independently execute the filing plans for Europe in line with corporate, regional, and local business objectives
• Maintain awareness of new and developing legislation, regulatory policy, and technical guidance relating to small molecule therapies across oncology, neurology, endocrinology, and metabolic therapeutic areas, and communicate their implications cross-functionally
• Review and provide strategic input/advice on EU CTR submissions and/or queries  
• Ensure high-quality regulatory submissions are made on time and achieve Corcept’s goals
• Build out a team that oversees regulatory-related launch and post-marketing activities in the EU
• Work closely with the Quality Assurance department on relevant regulatory procedures applicable to the European region

Preferred Skills, Qualifications, and Technical Proficiencies:

• Bachelor of Science in a scientific discipline, Pharm D (/Pharmacist) or PhD preferred
• 12+ years of experience with leading EU and non-EU regulatory submissions and interactions with EMA and national agencies
• Regulatory-related product launch and post-marketing activities experience 
• Experience with and knowledge of European regulatory regulations, directives, and guidelines
• Must be a strong team player, a fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills

Preferred Education and Experience:

• Deep knowledge of European regulatory regulations, directives, and guidelines
• Passionate about strong and to-the-point written work product
• Excellent planning, organization, time, and stakeholder management skills, including the ability to support and prioritize multiple projects
• Strong interpersonal capabilities and ability to build and maintain networks globally
• Possesses a sense of urgency; identifies challenges and problems and takes the initiative to identify solutions

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The Quality Assurance Operations Manager is responsible for a variety of operational activities pertaining to assuring product quality and compliance with the manufacture, testing, control, validation, and release of pharmaceutical drug substance and drug product for commercial and clinical distribution. This role will also be responsible for the oversight of 3PLs and work closely with the QPs to distribute products in EU. This is a remote role.

Responsibilities:

• Act as Quality lead and support in various Chemistry, Manufacturing and Controls (CMC) projects
• Work cross-functionally with the CMC group to provide oversight and resolve quality investigations of issues that occur at contract manufacturing and testing organizations
• Perform review of executed batch records and test data and perform product disposition
• Review and approval of validation protocols and reports (e.g., process, method, etc.)
• Lead and support quality audit of contract service providers
• Develop, review, and revise Standard Operating Procedures (SOPs) to reflect current industry best practices and regulatory standards
• Generate and review Quality and Technical Agreements with Contract Service Providers (CSP)
• Perform quality trends analysis and reports, recommending continual improvements opportunities
• Support the management and growth of the Quality Assurance Operations team with the goal of attracting and developing talent, creating a rewarding professional environment, and ensuring that the team’s capabilities meet Corcept’s future needs
• Support the QP/RP to ensure timely disposition of batches
• Provide cross training development opportunities, mentor and coach junior QA team members

Preferred Skills, Qualifications and Technical Proficiencies:

• Strong QMS experience in the EU and knowledge of EU country specific requirements
• Strong technical knowledge of analytical chemistry and pharmaceutical manufacturing technologies and processes
• Strong experience with executed batch record review and in-depth knowledge of quality and regulatory requirements for the release of pharmaceutical products
• Ability to work independently and communicate effectively with project team members and management groups and suppliers
• Work well in a project team environment with solid problem analysis and decision-making ability
• Ability to lead or support internal and external compliance audits of suppliers, CTLs, and CMOs
• Ability to work independently in addition to clearly and concisely communicate both in writing and verbally
• Ability to identify compliance risk and recommend mitigations
• Ability to author, review, and approve SOPs and other controlled documentation for compliance with applicable regulations
• Strong statistical mindset and metric presentation
• Proficient computer skills are needed with experience using Microsoft Word, Excel, PowerPoint, and Visio
• Travel required

Preferred Education and Experience:

• Bachelor’s or master’s degree in science, engineering or related field
• At least 10 years in the bio/pharmaceutical industry
• At least 5-10 years in Quality Assurance
• Knowledge in application of 21CFR211, global cGMP regulations, and ICH guidelines regarding good manufacturing practices in the development, manufacturing, testing, delivery, and control of pharmaceutical products

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We are seeking an Associate Director to lead Corcept’s Document Control Program, an essential element of our Quality Management System (QMS). This leadership role requires a proven track record of advancing document control by remediating critical gaps, and implementing sustainable, risk-based controls that achieve GxP requirements. This role owns the strategy, execution, and compliance of the program and its supporting software.

This leader champions a culture of SOP engagement, and accountability across departments, ensuring that stakeholders adhere to Corcept’s SOP standards. This involves communicating and coordinating SOP revisions involving everything from simple changes to complex system overhauls under compressed timeliness.

This role requires a strong, focused leader who delivers high-visibility changes, drives implementation with resilience and clarity, and resolves obstacles and dynamic priorities. The leader communicates a clear and compelling vision, and guides teams through change using collaborative "come with me" leadership.

The role requires pharmaceutical or biotechnology experience involving single product to multi-product transformation including the design of scalable business processes, modification of computer systems, and updating metadata.

This is a hybrid role typically requiring on-site presence at least 3 days per week.

Responsibilities:

• Lead and mentor a committed team of Document Control professionals, aligning through shared purpose, empowerment, and transparency. Foster a culture of ownership, agility, quality excellence, and professional growth
• Strengthen the Document Control Program and supporting software by remediating compliance risks, and architecting processes, metadata, and complex computer system configurations including security
• Evaluate and implement solutions to support a scalable, multi-product environment in compressed timelines resulting in a robust, inspection-ready program that achieves GxP standards
• Partner closely with Training program lead to integrate document process changes and system configuration changes to proactively address organizational change management of impacted personnel
• Assume software Business System Owner responsibilities, ensuring data and metadata maintenance and periodic system review
• Drive and manage high-volume SOP authorship, revision, and implementation — often under accelerated timelines
• Lead technical sessions as needed that elicit system requirements to scale Veeva QDS (QualityDocs) capabilities and ensure projects line up with Quality Systems project portfolio
• Establish and track key performance indicators (KPIs) to monitor and ensure system effectiveness, inspection readiness, and accountability

Preferred Skills, Qualifications and Technical Proficiencies:

• Demonstrated success in leading organizational change management initiatives, including system and procedural overhauls
• Support compliance remediations by ensuring high volume of SOP changes are completed within abbreviated timelines
• Build effective partnerships across GxP departments including QA, Regulatory, IT, Manufacturing, and Development to build solutions
• Technical expertise as business owner of Veeva QDS with demonstrated success in transforming systems, associated business processes, and configuration from a single product to a multi-product and multi-geographical site system
• Clear and concise written communication skills to align documentation to Corcept’s Quality Policy/Manual, using established Document Control tools to deliver consistent, quality written work
• Inspirational leadership style with a proven ability to guide teams through complexity and ambiguity
• Experienced in presenting to executive leadership and acting as a visible leader during audits and inspections
• Excellent verbal and written communication skills with the ability to influence a wide range of stakeholders in various departments
• Strong working knowledge of pharmaceutical GxP standards and their impact on SOPs, work instructions, and controlled documents
• Designed applicable document control processes that integrate with GxP Training program
• Extensive experience as Business System Owner of Veeva QDS

Preferred Education and Experience:

• BA/BS degree in a scientific/technical/engineering field
• 10+ years of experience in pharmaceutical or life sciences industry
• Veeva certification

The pay range that the Company reasonably expects to pay for this headquarters-based position is $186,500 - $219,400; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

 Applicants must be currently authorized to work in the United States on a full-time basis.

The Corcept Quality Systems Technology (QST) leader will have primary responsibility for evaluating Veeva Quality software projects and prioritizing the most critical projects for the QA department and Corcept. This role requires a strategic thinker who partners cross-functionally to achieve shared objectives, prioritizes and justifies software projects to meet objectives, and sets clear direction to get there. The leader should be comfortable leading complex system projects, support validation tasks as needed, and directly manage project execution while maintaining strategic oversight. 

The leader should demonstrate the ability to translate business growth and rising complexity into a coherent software strategy, including a 2-year strategic framework that supports sustained growth and organizational maturity. Projects include new implementations, software enhancements, and other continual process improvements. 

The role will support all of Corcept’s quality and GxP operations, leading cross-functional collaboration across teams with diverse and opposing priorities and aligning on the best path forward to achieve high-impact outcomes. Because QST supports all phases of clinical, manufacturing, and development operations, this individual will need to apply sound judgment in developing practical, risk-based, and phase-appropriate solutions.  

This is a hybrid role that typically requires on-site presence three days per week.

Responsibilities: 

• Align QST objectives with departmental and corporate expansion growth goals, ensuring projects deliver measurable business value
• Partner cross-functionally to deliver phase-appropriate solutions that strengthen Corcept’s quality management system and meet business needs 
• Evaluate, prioritize and successfully deliver scalable software solutions that support GxP-compliant operations, ongoing enhancements, and day-to-day operations 
• Exercise sound judgment in balancing GMP and GCP considerations to meet regulatory and operational requirements 
• Balance competing priorities and compliance risks, while maintaining project momentum 
• Serve as Subject Matter Expert (SME) for Veeva Quality in regulatory inspections by proactively identifying compliance risks, implementing corrective actions or mitigations 
• Lead, coach, and develop the Quality Systems team by setting goals, identifying development opportunities, and assisting in individual career development and growth 
• Partner with teams to manage vendor relationships, agreements, and user licenses to scale with Corcept’s expanding footprint and evolving software needs 

Required Skills, Qualifications, and Technical Proficiencies: 

• Demonstrated ability to navigate ambiguity and set direction 
• Proven leadership skills in a cross-functional role 
• Guide and develop team members 
• Excellent problem-solving and meeting facilitation skills 
• Excellent written and oral communication skills 
• Working knowledge of Veeva Quality, LMS systems 
• Ability to influence others at various levels of the organization 
• Previous hands-on configuration experience is a plus  
• Direct involvement and experience with regulatory inspections and audits 
• Vendor evaluation and selection process 
• Working knowledge of principles for software validation, CSA, GAMP5 
• Experienced and well-versed in System Development Lifecycle (SDLC) 

Preferred Education and Experience: 

• BA/BS in a scientific discipline 
• 10+ years’ experience in pharmaceutical QA 
• Strong knowledge of GCP and GMP requirements, including ICH E6, ICH Q9-Q10, 21 CFR 210/211, and specific regulatory authority requirements (FDA, EMA, PMDA, etc.) 
• Experience working with enterprise systems, integrations, and phase-appropriate QMS implementation 
• Experience with managing budgets 

The pay range that the Company reasonably expects to pay for this headquarters-based position is $192,700 – $226,700; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

 Applicants must be currently authorized to work in the United States on a full-time basis.

Lead the preparation of CMC Regulatory documents from pre-IND to marketing authorization submissions in multiple therapeutic areas, molecules, and regions. This position will lead direct reports in the CMC regulatory team, keep up to date on evolving regulations, and lead regulatory intelligence activities. This is a hybrid role that typically requires on-site presence three days per week.

Responsibilities:

• Effectively maintain, and motivate a high-performing regulatory CMC team, including developing, coaching, and mentoring diverse, talented, and driven staff
• Lead regulatory - CMC intelligence activities
• Lead regulatory CMC activities for assigned projects consistent with global regulatory requirements , and company policies and procedures
• Provide Regulatory CMC guidance to internal teams and lead cross-functional teams to plan and prepare briefing packages, and CMC sections for INDs, and equivalent IMPD sections for CTAs, NDAs/MAAs and other global submissions
• Assess the regulatory impact of proposed manufacturing process changes
• Track regulatory CMC commitments; manage ongoing regulatory submissions and future reporting requirements, including annual reports
• Lead interactions with regulatory agencies for assigned programs
• Maintain knowledge of the global regulatory CMC environment and applicable regulations and guidelines, and communicate changes in regulatory information to cross-functional teams

Preferred Skills, Qualifications and Technical Proficiencies:

• Has successfully led responses to health authorities or other critical submissions while maintaining agreed timelines
• Demonstrated leadership and success in management of regulatory activities with a proven track record of effective collaboration with Global regulatory agencies
• Excellent verbal and written communication skills

Preferred Education and Experience:

• Bachelor's or advanced degree in a scientific discipline, with 10+ years of experience working in Regulatory Affairs in the biopharmaceutical industry
• Experienced in building, developing, and managing high functioning teams
• Direct experience with pharmaceutical regulatory submissions and product approvals, managing major regulatory filing(s) such as IND/CTA or NDA/MAA
• Direct experience with regulatory submissions to PMDA is desirable
• Experience with small molecules is preferred
• Experience in successfully leading assigned activities within cross-functional teams

The pay range that the Company reasonably expects to pay for this headquarters-based position is $238,900 – $281,100; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

 Applicants must be currently authorized to work in the United States on a full-time basis.