Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Associate Director, Regulatory Operations

Expired Job

Avexis Bannockburn , IL 60015

Posted 2 months ago

Overview

Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101. We are in the midst of an incredible journey, and are looking for passionate individuals to join us on this important mission.

AveXis, Inc., a Novartis Company, is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.

AveXis is seeking an Associate Director, Regulatory Operations.

Responsibilities

  • Collaborate with teams to plan, create and submit original U.S. INDs and amendments, original U.S. BLAs, amendments and supplements, EU MAAs, Canadian NDS', amendments and variations in eCTD format and ex-US clinical trial applications in electronic or paper formats, as required (formatting, publishing, submitting, life-cycling, and archiving sequences).

  • Oversee technical aspects for submissions (e.g., eCTD document granularity, utilization of content templates, document formatting, eCTD application location and lifecycle assignment, publishing, QC, validation, and transmission to regulatory health authorities).

  • Serve as system owner for regulatory information tools and systems (e.g., eCTD publishing tools, and electronic templates).

  • Manage submission vendors to support Regulatory submissions goals.

  • Maintain expert knowledge of electronic submission and computerized system validation standards.

  • Participate in the writing and reviewing of Regulatory SOPs, Work Instructions, and internal guidelines.

  • Identify potential risks to submission plans and propose risk mitigation strategies.

  • Ensure tracking and archiving of regulatory communications and submissions.

  • Represent Regulatory Operations in project teams to support submission planning and ensure coordination of system development activities.

  • Manage Regulatory Operations associates.

Qualifications

  • 5-7 years' experience working in a Regulatory Operations environment with demonstrated ability to present and articulate requirements.

  • Detailed knowledge of eCTD publishing systems, EDMS technology, and publishing software.

  • Experience managing EDMS, regulatory publishing systems, and tracking databases.

  • Advanced user skills using MS Word, MS SharePoint, Adobe Acrobat Professional, eCTD content templates and experience with MS Excel, MS PowerPoint, and MS Project or Smartsheets.

  • Familiarity with interpretation of applicable FDA, Canadian, EU and ICH guidelines related to clinical trial and marketing applications.

  • Demonstrated experience and a clear understanding of submission content and format requirements.

  • The ability to multitask, prioritize, and work under pressure in adhering to deadlines.

  • Strong oral and written communication and interpersonal skills.

  • Strong project management and organizational skills.

  • Ability to apply knowledge to new situations.

The level of this position will be based on the final candidate's qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.


See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Vice President Regulatory CMC

Avexis

Posted 3 days ago

VIEW JOBS 11/16/2018 12:00:00 AM 2019-02-14T00:00 Overview Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101. We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, Inc., a Novartis Company, is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene. AveXis is seeking a Vice President, Regulatory CMC to lead all regulatory CMC business, oversee regulatory CMC activities, and maintains the regulatory CMC applications. Responsible for formulating the regulatory CMC strategy of submissions to the US FDA, EMA, and other regulatory authorities as well as managing interactions with regulatory authorities on CMC issues. Responsibilities * Create overall regulatory CMC strategy for new product candidates to attain rapid regulatory approvals. * Develop, lead and drive CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance. * Ensure strategies are successfully executed, proactively modifying strategy and actions to adjust to environment changes. * Lead and drive all CMC content for submission activities (planning, authoring, reviewing, coordination, submission) for original INDs, IND amendments, investigational medicinal product dossiers (IMPD) for inclusion in Clinical Trial Applications, BLAs and MAAs. * Serve as RA CMC liaison with the FDA and develop global Regulatory contacts. * Participate in multidisciplinary efforts to prepare CMC updates for regulatory documents including Investigator Brochures, Annual Reports and Background Documents for Regulatory Authority meetings. * Work with regulatory organizations and partners Europe and Asia to prepare applications, respond to queries to enable maintenance of CMC needs for clinical activities outside of the United States. * Establish, manage, and maintain a knowledge base of current and emerging CMC regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues to colleagues. * Ensure communication and alignment on CMC regulatory strategy through partnership and communication with internal key stakeholders, including representing the regulatory department at strategy and specification committee meetings. * Assure compliance with regulatory standards and guidance documents. * Ensure that CMC-related changes are reported to authorities in accordance with regulatory requirements. * Conduct risk assessments of global CMC regulatory issues. * Builds world class Regulatory CMC functions to meet the Company's growing business needs. * Maintains and continues to build the Company's excellent reputation with the regulatory authorities. * Directly supervises employees. * Indirectly supervises employees through a dotted line structure or via other subordinate managers. Qualifications * MS/MA degree in related discipline and 15 years of related experience with at least 5 years at a director or above role; PhD, MD, or PharmD is preferred. * A proven track record of successes in neurological drug submissions (e.g., NDA, IND, MAA), is preferred. * Experience with biologics and cell therapy drug development. * Experience with gene therapy drug development preferred. * Knowledge of the drug development process, drug laws, and global regulations and requirements. * Strong analytical skills, problem solving ability and presentation skills required. * Flexibility and ability to prioritize and manage multiple tasks simultaneously. * Preference to manage projects. * Effective oral and written communication * Possess ability to apply and integrate the regulatory and compliance experience into business strategy. * Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing. * Interprets, executes and recommends modifications to companywide policies and/or divisional programs. * Develops departmental policies and oversees and/or authorizes their implementation. Establishes organizational policies in a major segment of the company. * Has extensive knowledge of other related disciplines. * Applies strong analytical and business communication skills. * Proficient with broad use computer applications such as MS Office and specialized applications as needed for job. Travel up to 15% required, US and EU. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. Avexis Bannockburn IL

Associate Director, Regulatory Operations

Expired Job

Avexis