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Sr. Director, Regulatory Affairs (Oncology)

Employer
Corcept Therapeutics
Location
Menlo Park, CA
Start date
Feb 25, 2024

View more

Discipline
Regulatory, Regulatory Affairs, Science/R&D, Oncology
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Biotech Bay

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 Regulatory Affairs Sr. Director’s role leads regulatory strategy, regulatory filings and health authority interactions to support oncology products.

The Sr. Director provides strategic and operational leadership in support of oncology drug product development. This position will focus on nonclinical and clinical regulatory aspects of product development.

The Sr. Director will work with functional areas and project teams to support product development and approval. This role requires strong knowledge and interpretation of global rules, regulations, and guidance governing drugs in all phases of development.

The Sr. Director will be onsite in Menlo Park, CA, typically 3 days per week.

Responsibilities

Develop global regulatory plans to facilitate the progress of programs in all phases of development; identify risk mitigation strategies and influence project teams and to maximize the likelihood of regulatory success.

Doing this well requires

  • Supporting efficient conduct of development programs, while maintaining compliance with ICH requirements, regional requirements, and scientific and company procedures
  • Managing regulatory documents/submissions supporting IND/CTA and marketing applications
  • Preparing for and attending meetings and teleconferences with FDA and ex-US regulatory agencies
  • Maintaining knowledge of and monitoring changes in global rules, regulations, and guidances governing drugs and biologics in all phases of development
  • Initiating and contributing to local and global process improvements

Preferred Skills, Qualifications and Experience

  • 10+ years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries
  • Extensive drug development experience and experience developing regulatory strategies
  • Experience preparing global regulatory submissions including INDs, CTAs, marketing applications, and meeting briefing packages
  • Experience with regulatory submissions and marketing applications in Electronic Common Technical Document format
  • Experience with regulatory inspection readiness
  • Ability to travel to agency meetings (US and international authorities)
  • Scientific background (oncology, endocrinology, neurology desirable)
  • Senior management experience, ability to develop a team
  • Excellent verbal/written communication skills

Preferred Education

  • PhD in scientific discipline, Medical Degree or PharmD

The pay range that the Company reasonably expects to pay for this headquarters-based position is $242,000- $285,000; 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.

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

Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview.  Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.

 

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