Senior Project Manager, Regulatory
Job Opportunity at Spark Therapeutics, Inc

Posted on Jan 9

http://www.sparktx.com    215-220-9300

Location: Philadelphia, PA
Job Type: Full Time
Job ID: W4135513

Senior Project Manager, Regulatory serves as a resource to the department.  The Senior Project Manager, Regulatory will represent the Regulatory function in project teams and manage and track global regulatory projects to established timelines and budgets from initiation through to completion.    S/he is responsible for ensuring team and project commitments (ie scope, schedule, budget) are met and for communicating program status to senior leadership on a regular basis.

The position will also involve developing, communicating and building consensus for operating goals that are in line with the department.  Provides leadership by communicating and providing guidance towards achieving department objectives, reviewing performance, and identify areas of concern that are impacting project timelines
The position requires the ability to drive strategic activities while also managing tactical activities and communicating effectively with a large group of stakeholders.

  • Lead the planning and implementation of strategic regulatory projects
  • Work with cross functional project teams to facilitate the definition of project scope, goals, objectives and deliverables with management, supporting business strategies
  • Set goals and metrics for project timelines, and review performance against the goals, track project deliverables using appropriate tools and methods
  • Develop project implementation plans and tasks, manage resource requirements and workload planning to ensure on-time completion of projects and tasks
  • Work with management to identify key contributors, stakeholders and skill sets
  • Schedules, leads and documents meeting minutes, action times, key decisions, key issues of project core team meetings
  • Monitor and track the status of ongoing regulatory projects; report weekly updates on progress of the project to all stakeholders and to regulatory affairs staff on project timelines
  • Identify risks and steps for mitigation; escalate issues for concern or potential business disruption and delays
  • Implement and manage project changes to achieve project outputs within required timelines
  • Manage project budget, identify required travel, contract resources, licenses, fees associated with the project and timing of accruing these expenses
  • Act as a liaison between departments to coordinate discipline specific work for regulatory activities
  • Lead project evaluations and assessment of results; identify lessons learned once the project is complete
  • Propose working processes and continuous improvements.
  • Participate in the development & implementation of new regulatory policies, processes, systems, and SOPs and train key personnel on them
  • Support the development of regulatory strategies and plans to advance Spark products through the regulatory review and approval process globally
  • Actively contribute to the development and implementation of regulatory processes for multi-country trials
  • As appropriate, work with department heads to ensure assurance of quality, compliance and timeliness of regulatory work output

  • Other projects and duties as may be required
  • Support regulatory activities and coordinate filings (e.g. IND, amendments, BLAs, Supplements) and documentation as appropriate
  • Prepare and deliver high quality slide presentations for management briefings, internal and external audiences

  • Knowledge of project management software packages.
  • Ability to document key decision discussed during project meetings.
  • Ability to handle multiple tasks and strong attention to detail.
  • Excellent interpersonal communication and organizational and planning skills. 
  • Successful performance in a high-intensity work environment.
  • Excellent writing skills.
  • Excellent problem identification and problem solving skills; ability to exercise judgment independently.
  • 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. 
  • Attention to detail and accuracy
  • Excellent problem identification and problem solving skills; ability to exercise judgment independently.
  • 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. 

Bachelor’s degree in a related field
Generally has 7-10 years of relevant experience in biotech/pharma industry preferably in regulatory affairs, quality assurance, R&D, operations or related area
Generally has 3-5 years of regulatory affairs project management experience
Must have solid working knowledge of the regulatory lifecycle, regulatory principles and clinical development 
Knowledge of project management software packages.
Demonstrated ability to meet deadlines
Demonstrated proficiency with Microsoft Project, Word, Excel and Power Point
Domestic and international travel as required (15%)


Transforming Patient’s Lives
. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.

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