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AlloVir - Head, Regulatory Operations

Company: ElevateBio
Location: Cambridge
Posted on: September 16, 2020

Job Description:

Title: Head, Regulatory Operations - AlloVir

Location: Cambridge, MA

Reports to: Chief Regulatory & Safety Officer

The Role

At AlloVir (formerly ViraCyte) it is our mission to develop and deliver transformative cell therapies for patients suffering from life-threatening virus-associated diseases. We are the leader in the clinical development of novel cell therapies designed to restore natural T-cell immunity against devastating virus-associated diseases in immunocompromised patients, including stem cell and organ transplant recipients. AlloVir has built an innovative technology platform developed by researchers at Baylor College of Medicine’s Center for Cell and Gene Therapy. Our proprietary technology platform delivers commercially scalable, “ready-to-administer” solutions by leveraging off-the-shelf, allogeneic, multi-virus specific T-cells, designed to treat or prevent multiple devastating virus-associated diseases. We are now planning and advancing mid- and late-stage clinical trials across our growing product pipeline.

AlloVir is seeking a Head of Regulatory Operations. This person will lead and oversee all aspects of Regulatory Affairs Operations. The primary scope of the Head of Regulatory Affairs Operation role is to set up and oversee the regulatory operation function.

RESPONSIBILITIES

Design, implement, and provide continuous improvement of regulatory systems and processes striving for operational regulatory excellence, built on the pillars of Regulatory Project Management; Regulatory-, Quality-, Pharmacovigilance- and Safety-Related Operations; Vendor Management; and Information Management Systems

Work closely with internal stakeholders to establish Regulatory Information Management (RIM) systems and databases for the archival of all regulatory information

Provide technical support, guidance, and mentoring of regulatory operation team members

Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development

Build and maintain excellent relationships with relevant regulatory agencies, contractors, vendors, corporate partners, and all other external stakeholders

Lead project management activities related to the preparation and tracking of regulatory documents/submissions

Set up, monitor, and improve tracking/control systems. Keep abreast of regulatory procedures and changes.

Support optimization of publishing best practices and global submission standards in accordance with regulatory requirements worldwide

Support system audit and/or GxP inspection or due diligence regarding regulatory systems and regulatory documentation; work closely with counterparts in Clinical Development, Technical Operations

Active participant of the global Regulatory Affairs & Safety Leadership Team

QUALIFICATIONS

REQUIRED

Degree in Life Sciences or related discipline

Minimum 10 years of experience and broad knowledge in the field of Regulatory and/or Safety Operations, Regulatory Project Management, Regulatory Information and/or Systems Management

Expertise in defining and implementation of new system strategies, standards, and related regulatory processes

Direct experience interfacing with relevant global regulatory authorities

Experience in interpretation of global regulations, guidelines, and regulatory policy matters

Expertise in the preparation of global regulatory submissions and supportive amendments or supplements

Strong leader, and team player who demonstrates initiative, ability to analyze problems, identify alternative solutions and implement recommendations for resolution

Self-motivated, flexible, and creative leader, able to prioritize, multitask and work in a fast-paced and demanding environment.

Excellent written and verbal communication, especially presentation and facilitation skills

Good leadership skills with demonstrated ability to mentor, and develop others

PREFERRED

Advanced degree (PharmD, MSc, PhD, MD)

Cell and gene therapy experience

Join the leader in the development of novel cell therapies with a focus on restoring natural immunity against life-threatening virus-associated diseases in patients with severely weakened immune systems. Over many years, AlloVir’s world-leading scientists have developed a highly innovative pipeline of allogeneic, off-the-shelf, T-cell therapies being studied to treat and prevent many devastating and life-threatening virus-associated diseases. The company’s lead product, Viralym-M, an investigational cell therapy to treat active virus-associated diseases, including from BK hemorrhagic cystitis, cytomegalovirus, adenovirus, Epstein-Barr virus, JC virus and human herpesvirus 6. AlloVir’s technology and manufacturing process enables the potential for the treatment and/or prevention of up to six devastating viruses with each single allogeneic cell therapy.

Join AlloVir to help advance the development of this innovative technology platform and multiple mid- and late-stage clinical trials to help severely immunocompromised patients. AlloVir is part of the ElevateBio-family of companies with access to ElevateBio BaseCamp’s industry-leading, centralized cell and gene therapy manufacturing capabilities. By joining AlloVir, you will be able to not only advance innovative science but also a part of a truly new business model for advancing cell and gene therapies.

AlloVir is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic

AlloVir is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. AlloVir will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Keywords: ElevateBio, Cambridge , AlloVir - Head, Regulatory Operations, Other , Cambridge, Massachusetts

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