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AlloVir - Executive Director, Global Regulatory Affairs

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

Job Description:

AlloVir - Executive Director, Global Regulatory Affairs Title: Executive Director, Global Regulatory Affairs - 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 n Executive Director of Global Regulatory Affairs . Th e Executive Director will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with the global corporate strategy. He/She will be responsible for leading a comprehensive and strategic approach to developing and executing integrated global regulatory strategies that account for continuous interplay between major health authorities for AlloVir’s complex therapeutic portfolio. The Executive Director will liaise regulatory communications on behalf of the company with domestic and international regulatory authorities, contractors, internal and external stakeholders. He/She will be responsible for providing regulatory support for various departments, projects, and teams/committees.

RESPONSIBILITIES

The successful candidate will be responsible for:

Developing worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.

Representing AlloVir to external organizations through direct communication with the Food and Drug Administration (FDA), as well as all necessary global regulatory agencies, including telephone calls and e-mail; chairs meetings between our Company and the FDA.

Reviewing and providing final approval of worldwide marketing applications, clinical study reports, protocols, investigators’ brochures before release from the Company to external agencies and investigators.

Represents Global Regulatory Affairs (GRA) within the company's internal committees to provide regulatory advice. Conducting initial investigational new drug (IND)/clinical study authorization (CSA) content review and approval to facilitate initial approval by regulatory agencies for conduct of clinical trials.

Participating in regulatory due diligence activities for licensing candidate review.

Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks.

Provide regulatory guidance to company personnel throughout the research and development process.

Set strategic direction and leads global regulatory submission process with submission teams, including marketing applications and core briefing packages.

Develop and maintain the Core Data Sheet and lead global labeling team meetings.

Advise on global CTA submission strategy.

Direct the organization and preparation of clear and effective submissions.

Prepare and deliver effective presentations for external and internal audience.

Monitor and analyze appropriate regulatory agency activities in areas of interest to the company. Assess impact on programs.

Mentor Regulatory Managers and guide direct reports in carrying out responsibilities.

Responsible for coordinating activities and career development of direct reports.

Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position.

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

Provide input to Regulatory Senior Management teams

Maintain a global view as part of the whole regulatory team

Active participant of the global Regulatory Affairs & Safety Leadership Team

QUALIFICATIONS

REQUIRED

Degree in Life Sciences or related discipline required

Minimum 8 years employment working in a clinical practice, clinical research, or product development

Minimum 4 years experience in regulatory affairs

Expert knowledge within global regulatory landscapes

Direct experience interfacing with relevant global regulatory authorities

Experience in interpretation of global regulations, guidelines, policy statements, etc.

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

Strong leader, and team player who demonstrates initiative, willingness to roll-up his/her sleeves, and problem solve

Ability to thrive in a fast-paced environment

Strong writing skills is a must, including ability to author documents

Ability to communicate effectively and represent the Regulatory and Safety organization

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 - Executive Director, Global Regulatory Affairs, Other , Cambridge, Massachusetts

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