Head of Regulatory, CMC
Date: Jan 29, 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 Head of Regulatory CMC will be responsible for leading preparation of high quality regulatory submission content focusing on chemistry, manufacturing, and control (CMC) to support global clinical development, registration, and product life cycle management. He/She will provide leadership, high level strategic and operational regulatory direction and mentorship on projects including, but not limited to CMC regulatory strategies, CMC regulatory requirements for clinical studies and marketing approval in domestic and international markets, CMC regulatory strategic development plans, and Health Authority interactions while ensuring that the latest requirements, standards and trends within the company and industry are met. The individual has departmental and corporate level influence and acts as an advisor/liaison to senior management in order to plan, evaluate and recommend CMC regulatory strategy. Externally, the individual will interface with outside regulatory agencies and business partners in regards to CMC development, regulatory, and registration strategies. He/she will support/lead development and implementation of department policies. The individual will also maintain awareness of global regulatory environment and assess and communicate impact of changes on business and product development programs. |
Responsibilities
% of Time |
Job Function and Description |
50% |
In collaboration with cross-functional CMC Teams, lead generation of CMC related submissions and components, including clinical trial applications, marketing applications, regulatory agency briefing packages, and response to regulatory authority queries. Provides strategic and operational regulatory direction and mentorship on projects including, but not limited to general CMC regulatory strategies, regulatory requirements for clinical studies and marketing approval in domestic and international markets, regulatory strategic development plans |
30% |
Liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key CMC regulatory issues and to expedite approvals of product
Maintains awareness of global regulatory environment and assesses impact of changes on business and product development programs. Facilitates policy and development of standard interpretation of global regulation
|
10% |
Serve as an integral member of cross-functional CMC team(s) and provide regulatory CMC leadership for assigned product(s). Provide robust regulatory guidance and support, both strategically and operationally, to the CMC Team(s) and regulatory team(s) |
Qualifications
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Key Skills, Abilities, and Competencies
Setting Strategy
Executing for Results
Leading Teams
Building Relationships and Using Influence
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Competencies
Nearest Major Market: Philadelphia