General Electric Senior Regulatory Manager CMC in Arlington Heights, Illinois
Job Description Summary
This role will be part of Regulatory CMC (Chemistry Manufacturing). In this role, you will provide strategic Regulatory CMC guidance and input in support of development projects and marketed products within Pharmaceutical Diagnostics (PDx). The key responsibility of Senior Regulatory Manager is to develop and maintain the Quality sections of the product dossiers throughout the entire life cycle of a product.
**This role can be remote but we prefer CST or EST time zone.
Key Responsibilities include:
To be the regulatory CMC strategy point of contact for project teams and to provide CMC related regulatory input for the assigned projects/products.
To direct, manage and review outsourced regulatory CMC related activities for assigned projects/products.
Build, or provide input to, submission strategy documents by defining variation type, data required to support submission, and submission documents required for the submission package. Review and approve published output.
In conjunction with the Global Regulatory Product Lead (GRPL), guide the project team in the project planning phase so that the correct data (and level of detail) to suit the needs of all markets is collected and submitted.
Review and, write and edit individual CMC submission documents/CMC dossier sections to support regulatory submissions.
Maintain registration tracking information and assist in the development of good document management practice standards.
Work closely with global RA and, regional RA’s to address questions from regulatory authorities.
In support of key brand CMC variations, proactively provide CMC related regulatory advice and assessment of impact to product dossiers. Advise project teams accordingly.
To support QA during audits and inspections as required.
To keep oneself updated on CMC related guidelines.
Bachelor’s Degree & a minimum of 5 years of experience in pharmaceutical industry, medical device or government / government relations.
Knowledge of US FDA regulatory requirements for both development and marketed pharmaceutical products.
Demonstrated experience of operating in a highly-regulated environment. Capable of applying analytical skills in a CMC regulatory environment.
Has experience working within a matrix organization and has strong interpersonal and influencing skills to work across disciplines. Has the capability to influence managers and help drive decisions at a project level.
Experience in electronic document management and Quality management systems. We use Veeva RIM but any QMS experience is valuable.
Advanced scientific degree.
Experience in pharmaceutical CMC regulatory or QA environment particularly with experience with injectable diagnostic or pharmaceutical products.
Knowledge of international CMC regulatory requirements.
Experience with Veeva RIM or other registration tracking tools.
Ability to work across cultures/countries/sites.
Demonstrated experience of prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer (https://assets.phenompeople.com/CareerConnectResources/GE11GLOBAL/en_global/desktop/assets/images/poster_screen_reader_optimized_w_supplement.pdf) . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
Relocation Assistance Provided: No