Scientific Search · 6 hours ago

Senior Regulatory Affairs Consultant

Philadelphia, PA

Contract

Remote

Senior Level, Lead/Staff

8+ years exp

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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

Qualification

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Regulatory AffairsFDA InteractionBLA SubmissionsClinical DevelopmentAnti-cancer ImmunotherapyProject Management

Required

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