Head of Regulatory, CMC

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.
 

% 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 
Proactively manages critical CMC issues, taking leadership for the regulatory contribution 

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)

• BS in a Biological Science required ( e.g. immunology, virology, molecular biology), MS/PhD preferred
• Generally has 15 years of pharmaceutical/biotechnology industry experience including 5 years of leadership experience within the CMC function
• Expert understanding of molecular biology and or virology required
• Experience in viral vaccine or viral vector gene therapy manufacturing is a plus

• Extensive regulatory experience including IND/CTA, NDA/BLA/MAA, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, developing and implementing complex regulatory CMC strategies with a proven track record of significant regulatory accomplishments.
• Ability to understand technical aspects of manufacturing and quality control assays and describe then in regulatory submissions and understand impacts on reg
• Development strategies to discuss CMC matters with health authorities to lead the development of briefing documents
• Strong interpersonal skills and ability to collaborate effectively with various technical area experts including process development, analytical, manufacturing, quality, and supply chain
• Experience and knowledge in the preparation of electronic submissions
• Knowledge and understanding of US and ex-US regulations and ICH guidelines
• Highly computer literate (Word, Excel PowerPoint), including formatting and getting document submission-ready
• Proactively manages critical CMC issues, taking leadership for the regulatory contribution Excellent written and communication skills and attention to detail

Setting Strategy

• Demonstrates a long-term perspective that extends beyond the immediate initiatives; visualizes and articulates a clear direction for Spark during times of uncertainty
• Intellectual curiosity and dedication to science, innovation, and complex problem-solving
• Commitment to strategic priorities and an increasingly aligned and disciplined organizational strategy

Executing for Results

• Focuses on how things are done as much as what is done; drives a culture of high performance with increased attention to discipline and process
• Sets aspirational goals to take organizational performance to the next level, reinventing the operating model when appropriate; goes beyond conventional performance benchmarks to set world class best practice
• Navigates change and uncertainty; is agile in responding to feedback from within and outside the organization

Leading Teams

• Embraces and embodies the Spark values: “break the barriers, own your excellence, commit to collaborate, demonstrate the respect you seek, and above all, champion the patient;”
• Able to learn from colleagues, embraces perspectives from different backgrounds and fields, and step back to allow others to take action
• Thoughtfully leads through influence and maintains focus on larger priorities; delegates effectively while managing performance and holding direct reports accountable

Building Relationships and Using Influence

• Collaborates and looks to support other leaders; sees value in championing the work of the group over the individual
• Offers enthusiasm and empathy toward other leaders and their respective departmental goals; influences and ensures alignment toward common priorities
• Able to connect, engage in open dialogue, disagree when necessary, and compromise toward the greater good of Spark