Job Description
Job DescriptionCompany Information
Castle Creek Biosciences is a late-stage biotechnology company developing re-dosable cell and gene therapies. It is conducting a pivotal Phase 3 clinical trial of its lead candidate for patients with dystrophic epidermolysis bullosa (DEB). Castle Creek, a Paragon Biosciences portfolio company, is headquartered in Exton, Pennsylvania with additional office space in Chicago, Illinois. Learn more at castlecreekbio.com.
General Responsibilities:
- The primary purpose of this role is to establish product-specific regulatory strategies to support programs, from early development through global registration and life cycle management.
- Communicate regulatory requirements to team members both internally and externally.
- Evaluate proposed manufacturing changes and provide strategic regulatory guidance for optimal implementation of changes.
- Coordinate and/or lead development or preparation of CMC-related elements for clinical trial and/or marketing applications for submission to health authorities.
- Ensure submissions meet current regulatory standards, are of high quality, consistent, complete, and approvable.
Responsibilities:
- Develop and implement strategies and related processes and systems for efficient and timely application submissions and approvals.
- Provide guidance and advice to CCB senior management and staff to achieve goals related to drug commercialization, including regulatory timelines, regulatory strategy, and chemistry, manufacturing and controls.
- Liaise with and coordinate with all relevant external organizations, including contract manufacturing organizations and other business partners.
- Serve as a liaison with FDA and other regulatory agencies.
- Assist in the preparation for and attend meetings with regulatory agencies.
- Ensure company compliance with all applicable guidance, regulations and laws.
- Monitor the development of new requirements and regulatory procedures and advise senior management of the impact on the business or development projects.
- Maintain knowledge of existing and emerging regulatory guidance and share that knowledge with members of the organization.
Qualifications:
- Bachelor’s degree in Chemistry or Biological Sciences and at least 15+ years demonstrated industry experience in Regulatory Affairs (advanced degrees and CMC experience preferred).
- Knowledge of regulations relevant to cell and gene therapy development and approval.
- Good organizational skills.
- Strong leadership skills.
- Ability to work cross functionally in matrixed organization under strict deadlines and changing priorities with minimal supervision on routine assignments.
- Ability to effectively manage resources to achieve business objectives.
- Excellent written and oral communication skills.