Senior Level Regulatory Consultant - Contract - Philadelphia
黑料视频 is working alongside a biotech seeking a Senior Level Regulatory Consultant to join the team. In this role, you will provide strategic input and day-to-day guidance for assigned projects within the oncology and medical devices sector. You will work closely with cross-functional teams and report directly to the Head of Medical Affairs and Clinical Development.
Primary Responsibilities:
The successful candidate will work in a matrix environment and possess the credentials to provide both strategic input and day to day guidance for the projects assigned. The Contract Regulatory Affairs Lead will report directly to the Head of Medical Affairs and Clinical Development.
Professional Requirements and Qualifications
- 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
Soft Skills
- 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
Key Competencies
- Analytical Thinking: Ability to comprehend a situation by breaking it down into its components and identifying key or underlying complex issues. Systematically organizes and compares the various aspects of a problem or situation and determines cause-and-effect relationships and able to define and summarize actionable recommendations.
- Patient Focused: Dedication to enabling translation of preclinical research into impactful human therapies.
- Communication skills: Ability to understand the audience needs across all forms of communication (phone, in-person, email and documents) and to convey the information concisely and in an engaging manner.
- Self-motivated: To initiate strategic independent and collaborative work assignment(s); raises hand to assist coworkers proactively.
- Flexibility: Able to reprioritize as competing interests arise and to operate successfully in an environment with a developing structure.
- Accountability: Strong commitment to ensure quality and timely deliverables while maintaining and building relationships with coworkers, managers, vendors and client.
Most important:
- Person must have extensive experience within the oncology space.
- Prior experience with all regulatory submissions (BLA, sBLA, IND, etc)
- Deep relationship with the FDA
- Person will be responsible for helping to create a regulatory strategy for the organization
The Senior Level Regulatory Consultant's responsibilities will be:
- 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
If you are having difficulty in applying or if you have any questions, please contact Jenny Martin at j.martin@proclinical.com
黑料视频 is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
黑料视频 Staffing is an equal opportunity employer.
