The incumbent is responsible for identifying, implementing, and revising regulatory strategies for assigned projects, in association with his/her immediate supervisor, to ensure success of development projects and commercially marketed products at all stages in the regulatory process. The incumbent will also provide guidance to project teams to ensure compliance with applicable FDA regulations and guidelines.
- Serve as regulatory representative to project teams for assigned projects and products
- Provide regulatory expertise to project teams, specifically from a clinical, nonclinical and CMC perspective
- Provide regulatory support to Regulatory Operations
- Author documents for assigned projects, specifically from a clinical, nonclinical and CMC perspective
- Provide regulatory surveillance to keep Scientific Affairs Department informed of any new US regulatory guidance
- Support labeling changes to marketed products and investigational labeling
- Provide regulatory support for promotional labeling reviews and submission to regulatory agencies
- Serve as the regulatory representative on assigned project teams to provide updates on regulatory submissions and provide clinical, nonclinical and CMC regulatory strategy for product development
- Serve as regulatory contact for internal and external vendors for assigned projects
- Author documents to support regulatory submissions, which may include cover letters, clinical, non-clinical and CMC CTD sections for INDs, NDAs, BLAs, and ODAs per FDA/ICH guidelines where appropriate (including. IND amendments, NDA/BLA supplements, Annual Reports, labeling, pre-meeting packages, post-marketing commitment reports, etc.).
- Provide regulatory review of documents for submissions including but not limited to labeling, clinical documents (e.g., protocols, IB’s, etc.), non-clinical reports, advertising and promotional materials, etc. to ensure compliance with applicable FDA/ICH regulations and guidelines.
- Manage and track submissions for all projects assigned, which requires collaboration with internal and external team members and working closely with Regulatory Operations to ensure timelines are met
- In assistance with direct supervisor, provide support and regulatory guidance to the Scientific Affairs Department as needed
- Prepare regulatory assessments as required
- Monitor Federal Register for Food and Drug, FDA website and other websites as appropriate for new regulations, guidance, and meetings (public hearings and advisory boards) relevant to Leadiant’s drug products (commercial and under development) and ensure information dissemination accordingly
- Other duties as assigned
Specific Job Knowledge, Skill And Ability:
- Bachelor’s degree in Scientific Area; Graduate Degree preferred
- Minimum of 5 years of relevant work experience required
- Prior experience authoring regulatory documents required in CTD granularity; Direct experience in the preparation of submissions for drug applications (IND, NDA, and/or BLA)
- Experience with labeling and promotional labeling review and submission a plus
- Core strength in one or more of the following disciplines is preferred: Non-clinical (pharmacology/toxicology), Clinical, CMC
- Strong knowledge of FDA and ICH regulations and guidelines related to paper and eCTD submissions.
- Experience working in a DMS system preferred
- Excellent oral and written communication skills, including the ability to discuss regulatory strategy and requirements with senior management.
- Must work effectively with a team and individually.
- Must demonstrate excellent planning and organizational skills and an ability to generate creative solutions for complex problems.
- Must be able to work on multiple projects in parallel; must enjoy working in fast pace environment.
- Excellent computer skills and knowledge of Microsoft Office and Adobe acrobat; strong formatting skills and great attention to details required; use of templates is a plus.
Leadiant Biosciences, Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other legally protected characteristics. The EEO is the Law poster is available here: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.
If you need a reasonable accommodation because of a disability for any part of the employment process, please send an e-mail to Jobs@leadiant.com and let us know the nature of your request and your contact information.