Senior Director, Regulatory Cmc

At Corcept Therapeutics, we believe the potential impact of cortisol modulation on the future of health has long gone overlooked. That is why for twenty-five years we have pushed the boundaries of what is possible, driven by fiercely independent science, open collaboration and the curiosity to follow the data wherever it leads.
Our company is committed to building a culture that values diverse perspectives and the unique contributions of every employee. Our vibrant community is made up of over 300 people-medical practitioners, scientists, and industry professionals-all with the shared goal of advancing the science of cortisol modulation to treat serious disease.
Our work has uncovered over 1000 proprietary selective cortisol modulators, including our marketed product, Korlym ® (mifepristone), the first treatment available for those living with Cushing's syndrome, a life-threatening condition caused by excess cortisol activity. Today, we have a unique opportunity to revolutionize the treatment of severe endocrine, oncology, metabolism and neurology disorders and aim to deliver better outcomes for the people affected by them.
The Sr Director, Regulatory (CMC) reports directly to Vice President of Regulatory Affairs and is responsible for development of CMC Regulatory strategy from pre-IND to NDA/MAA submissions in multiple therapeutic areas. This position will lead direct reports in the CMC regulatory team, keep up to date on evolving regulations, and serve as the Regulatory -CMC voice for all Corcept products in a matrix environment. This role also requires expertise in writing and reviewing CMC sections of CMC dossiers for regulatory submissions.
Responsibilities

• Lead regulatory CMC activities for assigned projects in line with ICH requirements, regional requirements, and company policies and procedures
• Oversee planning, preparation, and submission of high-quality regulatory CMC dossiers within current within regulatory environment
• Track regulatory CMC commitments; manage ongoing regulatory submissions and future reporting requirements, including annual reports
• Oversee the development and implementation of robust CMC regulatory strategies and assess the regulatory impact of proposed manufacturing process changes
• Serve as the Regulatory Affairs representative and provide CMC guidance to internal teams and lead cross-functional teams to prepare briefing packages, Module 3 and 2.3 sections for INDs, and equivalent IMPD sections for CTAs, NDAs/MAAs
• Lead interactions with regulatory agencies for assigned programs
• Maintain knowledge of current regulatory requirements and communicate changes in regulatory information to cross-functional teams and senior management
• Effectively build, maintain, and motivate a high-performing regulatory CMC team, including hiring, developing, coaching, and mentoring diverse, talented, and driven staff
• Maintain knowledge of the global regulatory CMC environment and applicable regulations and guidelines. Lead regulatory - CMC intelligence activities

Preferred Skills, Qualifications and Technical Proficiencies

• Direct experience with pharmaceutical regulatory submissions and product approvals, managing major regulatory filing(s) such as IND/CTA or NDA/MAA
• Has successfully led responses to health authorities or other critical submissions while maintaining agreed timelines
• Experienced in building, developing, and managing high functioning teams
• Defining, crafting, and overseeing the execution of innovative regulatory strategies
• Extensive knowledge of FDA regulations and practices and ICH guidance as well as strong knowledge of global health authority regulations and practices
• Demonstrated leadership and success in management of regulatory activities with a proven track record of effective collaboration with Global regulatory agencies, including the FDA
• Excellent verbal and written communication skills
• Collaborative, analytical and interpretative skills that enable review and compilation of reports and other documents used in regulatory planning and submissions
• Ability to set priorities to meet timelines, to motivate and influence others; prior management experience
• Experience in successfully leading assigned activities within cross-functional teams

Preferred Education and Experience:

• Bachelors or advanced degree in a scientific discipline, with 15+ years of experience working in drug development in the biopharmaceutical industry and at least 8 years of experience in Regulatory Affairs; small molecule development experience desirable
• Some travel required. Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business needs

The pay range that the Company reasonably expects to pay for this position is $242,000 - $285,000 ; the pay ultimately offered may vary based on legitimate considerations, including job-related knowledge, skills, experience, and education. An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of medical, financial, and/or other wellness benefits, dependent on the position offered.
Applicants must be currently authorized to work in the United States on a full-time basis.
If you are based in California, we encourage you to read this important information for California residents linked here.
Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.
Please visit our website at: https://www.corcept.com/
Corcept is an Equal Opportunity Employer