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Job Details

Director Regulatory CMC - Gene Therapy

Company name
Ultragenyx Pharmaceutical

Location
Cambridge, MA, United States

Employment Type
Full-Time

Industry
Biotech, Sciences, Executive, Manager, Pharmaceutical

Posted on
Apr 03, 2020

Valid Through
Jul 17, 2020

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Why Join Us?

Be a hero for our rare disease patients

Ultragenyx is a commercial-stage biopharmaceutical company committed to developing novel therapies for the treatment of rare and ultra-rare genetic diseases. The company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are typically no approved therapies treating the underlying disease.

With the company’s recent acquisition of Dimension Therapeutics, the Ultragenyx Gene Therapy division was established. The Ultragenyx Gene Therapy division is headquartered in Cambridge, MA. We are looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene therapy.

Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission – to make a difference in our patients’ lives.

Come join our team during this exciting time of growth and opportunities! During the COVID-19 Outbreak we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our process will include remote based web-ex video discussions, interviews & onboarding.

Position Summary:

Position Summary

The Director of Regulatory CMC will manage related chemistry, manufacturing and controls (CMC) regulatory interactions and will help develop regional regulatory CMC strategies.

Position Reporting To:

Executive Director, CMC Regulatory Affairs

Responsibilites:

Develop the CMC regulatory strategies and manage related regulatory activities. Work with the Functional Departments to prepare project plans and timelines for assigned Ultragenyx’s products, including coordination and oversight of all types of regulatory CMC submissions.

Advise the global regulatory compliance of Ultragenyx’s pipeline of products including the evaluation of CMC related change controls, product deviations, the strategic assessment of process and product comparability, their regulatory impact and implementation.

Coordinate the preparation, review and filing of CMC sections of regulatory submissions and interactions with regulatory agencies using established Vault processes.

Provide regulatory submission planning to project teams and periodic status updates to Project Management and VP of Regulatory Affairs.

Advise CMC Team regarding agency requirements and establish regulatory options to support corporate objectives.

Ensure maintenance of the Vault commitment system and agency reporting obligations. Utilize Vault reporting system to issue periodic commitment status reports to Functional Heads, Project Management and VP of Regulatory Affairs.

Provide strategic CMC regulatory support, guidance and expertise, and act as the Regulatory Affairs primary point of contact to cross-functional teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines.

Work cross functionally in identifying issues that may delay timelines, providing solutions to difficult technical/functional issues associated with specific projects, as well as support the resolution of issues that arise.

Provide guidance and advice on regulatory environments; provide assessment of the impact of new and changing regulations/requirements.

Support other Regulatory Affairs functions as needed.

Qualifications:

BA/BS in a scientific field of study with 10 years of relevant experience working in Regulatory in the pharmaceutical/ biotech industry.

Strong knowledge, experience and leadership in interpretation of regulations and guidelines related to biologics drug development.

Experience in the Gene Therapy or Rare Disease area preferred.

Proven ability to analyze and organize information logically.

In depth understanding and application of industry standards and international regulations and guidelines.

Experience in communicating regulatory strategy, submission documents and plans both internally and externally.

The ability to coordinate and prioritize multiple projects in a fast-paced, deadline driven start-up environment.

Strong collaboration, team work, organizational skills at attention to detail

Excellent written and verbal communication skills.

Travel 20%

#LI-CZ1

Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by calling: (415) 483-8800 or by emailing us at talentacquisition@ultragenyx.com

. For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.

See our CCPA Employee and Applicant Privacy Notice

Note to External Recruiters

: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to :

talentacquisition@ultragenyx.com

Company info

Ultragenyx Pharmaceutical
Website : http://www.ultragenyx.com

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