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Regulatory Affairs Leader

Date: Aug 9, 2019

Location: Philadelphia, PA, US

Company: Spark Therapeutics

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

Summary

The global Regulatory Affairs Leader (RAL) provides strategic and operational leadership to cross-functional project teams responsible for gene therapy product development. The RAL working in collaboration with R&D, Clinical/ Nonclinical Development, Market Research, and Patient Advocacy & Program Management coordinates the development and execution of a functionally-integrated, global regulatory strategic plan for assigned programs.  The defined global strategic development plan defines key data requirements supporting specified product target labeling for a globally approved gene therapy product upon product launch, including aspects of market accessibility and reimbursement as required by global Health Technology Assessment Authorities (HTAs).  The RAL conducts and/or oversees regulatory authority interactions as required to support key program milestones from preclinical development through marketing authorization in target regions and countries as identified. The RAL coordinates interactions of global Ministries of Health (MoH) to validate the defined global regulatory strategy and directs multi-functional planning and conduct of regulatory agency meetings and interactions with MoH in collaboration with functional subject matter experts (SMEs) and senior management. The RAL is responsible for updating teams on new developments (competitive, regulatory policy/ guidance, review and/or compliance related topics) as relevant to global gene therapy regulatory product development.

Responsibilities

45%

  • Lead aspects of regulatory strategy development and execution including working with team members to complete submissions relevant to assigned projects and programs, in accordance with submission and approval requirements;
  • Provide guidance on content and provide review and approval of regulatory submissions including Request for Designation, Meeting Background Packages, Clinical Trial Applications, and Marketing Applications;
  • Manages, coaches and mentors members of assigned regulatory team; Acts as leader to assigned regulatory team for coordination of project related activities across the organization as required to complete project regulatory submissions;
  • Take initiative to actively maintain interdepartmental communications and demonstrated collaborative approach to ensure consensus and alignment across functions.

Responsibilities Continued

  • Provides estimated resources, budgets and timelines for assigned projects;
  • Actively participates in, and contributes to outside relevant conferences, including organizing and delivering presentations. May have presence on external regulatory committees/trade associations.
  • Participate with the regulatory leads in the preparation and maintenance of Clinical Trial Application dossiers, e.g. Investigational New Drug (IND) and Investigational Medicinal Product Dossiers (IMPDs), as well as, preparation and maintenance of product authorization applications, e.g. MAA, BLA as applicable.
  • Monitor applications under regulatory review; communicate application progress.
  • Participate with the regulatory leads in preparation of responses to objections/questions issued by Regulatory Authorities/ Agencies.
  • Participate with regulatory leads in preparation, submission and follow-up of Orphan Drug Applications, Pediatric Study Plans, Pediatric Investigational Plans, etc.
  • Report adverse events and other unanticipated problems to regulatory agencies and internal stakeholders.
  • Support the preparation, review, and approval of compliant regulatory documents throughout the product lifecycle. Work effectively with regulatory colleagues specializing in other functional areas to continuously improve regulatory systems, teamwork, and efficiency.

Responsibilities Continued

  • Prepare for and attend as needed meetings with regulatory authorities;
  • Anticipate regulatory obstacles and emerging issues, including changing regulations, throughout the product lifecycle and develop solutions with other members of regulatory and related teams. 
  • Evaluate proposed nonclinical, clinical, and manufacturing changes for regulatory filing strategies.
  • Participate in the development & implementation of new regulatory policies, processes, systems, and SOPs and train key personnel on them.
  • Other projects and duties as may be required

Requirements

  • Bachelor’s degree in life/health sciences required.
  • Minimum of 7-10 years in Regulatory Affairs;
  • 5 years pharmaceutical/biotechnology industry management experience;
  • Comprehensive knowledge of applicable regulations, including GCPs, GMPs and GLPs;
  • Global International regulatory experience, including US, EU, LATAM and APAC regions;

 

Technical Experience and Skills

  • Experience in a relevant area of biologics/ vaccines and or gene therapy product development; experience in rare disease development desirable.
  • Direct experience in interfacing with relevant regulatory authorities;
  • Experience in interpretation of regulations, guidelines, policy statements, etc.;
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements, including INDs, BLAs, CTAs, MAAs for biologics/gene therapy. Products.

Requirements Continued

Managerial Experience and Skills

  • Strong organizational skills, including the ability to prioritize personal, group and organizational priorities, resources and budgets;
  • Demonstrated success in leadership skills, including experience in leading multi-disciplinary teams, including coordination of collaborative & joint development programs;
  • Ability to represent the RA in project teams, committees and external meetings, including the ability lead and influence project teams, committees, etc. to attain group goals;
  • Supervisory/mentoring experience, including, prior experience coaching and supervising direct reports and organizational staff, including international sites and personnel;
  • Strong interpersonal skills with the ability to work effectively with executive staff representing regulatory, medical, scientific, manufacturing, legal, marketing functional areas;

Competencies

 

  • Excellent ability to read, analyze and interpret technical documents, technical procedures and government regulations;
  • Prepare and deliver effective presentations for external and internal audiences;
  • Ability to handle multiple tasks and strong attention to detail;
  • Excellent interpersonal communication and organizational skills;
  • Successful performance in a high-intensity work environment;
  • Knowledge of regulatory history, guidelines, policies, standards, practices, requirements and precedents;
  • Current knowledge and understanding of GxPs (GCPs, GLPs, GMPs) and ICH guidelines as well as FDA, international, and, if applicable, local regulations;
  • Current knowledge and understanding of Ethical guidelines of clinical research and the regulatory process;
  • Strong sensitivity for a multicultural/multinational environment.
  • Ability to Excellent problem identification and problem-solving skills; ability to exercise judgment independently;
  • Ability to follow scientific arguments, identify regulatory scientific data needs, and solve regulatory issues;
  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors;
  • Demonstrates good judgment in selecting methods and techniques for obtaining solutions. 
  • Demonstrated knowledge of the drug development process, with a focus on IND/CTA and NDA/BLA/MAA processes for gene therapy(ies) and advanced therapeutic products.
  • Excellent writing skills with an ability to prepare, revise, edit detailed information supporting nonclinical, clinical, CMC modules of submissions; Experience with electronic submissions preferred;

 

  • Excellent ability to read, analyze and interpret technical documents, technical procedures and government regulations;
  • Prepare and deliver effective presentations for external and internal audiences;
  • Ability to handle multiple tasks and strong attention to detail;
  • Excellent interpersonal communication and organizational skills;
  • Successful performance in a high-intensity work environment;
  • Knowledge of regulatory history, guidelines, policies, standards, practices, requirements and precedents;
  • Current knowledge and understanding of GxPs (GCPs, GLPs, GMPs) and ICH guidelines as well as FDA, international, and, if applicable, local regulations;
  • Current knowledge and understanding of Ethical guidelines of clinical research and the regulatory process;
  • Strong sensitivity for a multicultural/multinational environment.
  • Ability to Excellent problem identification and problem-solving skills; ability to exercise judgment independently;
  • Ability to follow scientific arguments, identify regulatory scientific data needs, and solve regulatory issues;
  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors;
  • Demonstrates good judgment in selecting methods and techniques for obtaining solutions. 
  • Demonstrated knowledge of the drug development process, with a focus on IND/CTA and NDA/BLA/MAA processes for gene therapy(ies) and advanced therapeutic products.
  • Excellent writing skills with an ability to prepare, revise, edit detailed information supporting nonclinical, clinical, CMC modules of submissions; Experience with electronic submissions preferred;


Nearest Major Market: Philadelphia

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