Regulatory Affairs CMC Sr. Specialist
Reporting to the Regulatory CMC Lead, the Regulatory CMC Senior Specialist will prepare high quality chemistry, manufacturing, and controls (CMC) regulatory submissions to support global clinical development, registration, and product life cycle management.
In collaboration with Regulatory Strategy Leads and cross-functional CMC teams, support generation of CMC related submissions and components, including clinical trial applications, marketing applications, regulatory agency briefing packages, and responses to regulatory authority queries. Incorporate regulatory strategies and well positioned content into high quality submissions to support successful outcomes.
Support the Regulatory CMC team to design, develop, and implement submission shell documents and best practices for CTD quality modules to streamline preparation of CMC submission content.
Maintain clinical trial applications and marketing applications according to regulatory requirements by preparing and submitting annual reports, distribution reports, routine reporting amendments. Support quality systems by reviewing and providing input to deviations, annual product reviews and assessing change controls for reportability to health authorities.
Participate on cross-functional CMC team(s) and provide regulatory CMC guidance for assigned product(s). Execute regulatory guidance and support as determined by the Regulatory CMC team, both strategically and operationally, through the CMC Team(s) and regulatory team(s)
- BS in Life Sciences
- 3 years of relevant experience
- Proven strength in technical writing
- Experience in biologics,cell and gene therapy
- Experience supporting regulatory submissions
- Excellent written and communication skills and attention to detail
- Ability to work independently
- Demonstrated strong organizational skills
- Strong interpersonal skills and ability to collaborate effectively with various technical area experts including process development, analytical, manufacturing, quality, and supply chain
- Experience with US and ex-US regulations and ICH guidelines
- Highly computer literate (Word, Excel PowerPoint), including formatting and getting document submission-ready
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
Nearest Major Market: Philadelphia
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.