Description:
Scientific Search client a clinical-stage biotechnology company focused on the development of novel patient-specific vaccines and immunotherapy strategies for the treatment of malignant gliomas and other cancers with unmet medical needs, has an immediate need for a Contract Regulatory Affairs Lead. This role will work in a matrix environment and possess the credentials to provide both strategic input and day-to-day guidance for the projects assigned.
Responsibilities
- Set the regulatory strategy for the organization and provide regulatory guidance to cross-functional teams and functional areas for project(s) assigned, i.e. from product/indication nomination through early to late-stage clinical development
- Plan and manage preparation and filing of regulatory submissions (clinical, nonclinical, CMC) for assigned product(s)/program(s) including BLA submissions as well as expedited programs such as Fast Track, Breakthrough, Orphan Drug Designation
- Interpret and explain regulatory agency communications to cross-functional teams and functional areas to ensure accurate functional area responses to agency requests and comments
- Stay current on changing regulatory environment and industry standard expectations, advise cross-functional teams and functional areas on new and changing regulations and guidance that may impact ongoing development programs
- Provide regulatory support to functional areas as they implement new or changed operating procedures for ongoing programs
- Provide regulatory support in preparation of standalone clinical documents such as investigator’s brochures, clinical study protocols, patient informed consent forms, clinical study reports
- Ensure regulatory submission documents and correspondence are of the highest quality in terms of content, organization, clarity of writing, and accuracy; ensure submission-readiness of all regulatory documents related to the project
- Work directly with external vendor for all stand-alone document publishing needs and publishing and compilation of eCTD submissions
Requirements
- Minimum of BA/BS + 8 years; MS + 6 years; or PhD/PharmD + 4 years of experience in regulatory affairs within the biotech or pharmaceutical industry, including direct experience interacting with the US FDA; experience with CBER preferred
- Regulatory or scientific experience with anti-cancer immunotherapy.
- Demonstrated track record of success partnering with the FDA and experience with FDA submissions (sBLA, BLA, IND, etc.)
- Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Willingness to think outside of the box and adapt best practices
- Ability to adapt in a constantly evolving environment
- Self-motivated with a strong sense of ownership in areas of responsibility
- High degree of professionalism, ethics and integrity
- For immediate consideration, send current resume to John Barry; john@scientificsearch.com & reference Job #19063 Check out scientificsearch.com for all current openings