Top Regulatory Affairs Executive jobs in Colorado

LGM Pharma is a leading contract development and manufacturing organization (CDMO) and provider of Active Pharmaceutical Ingredients (API). With excellent API sourcing and supply chain expertise together with our drug product contract development and manufacturing solutions, we are a premier end-to-end solutions provider to the global pharmaceutical industry.

We are a high-growth organization looking to accelerate the development and commercialization of high-quality therapeutics worldwide. We have offices in California, Texas, Kentucky, Florida and Israel.

RESPONSIBILITIES: 

•    Edit and write Pharmaceutical Development and R&D Quality system policy, procedure, work instructions and other supporting documents 

•    Drafts CMC sections of regulatory filings, manage submission projects and keep supporting documentation files organized and up to date

•    Interact with Formulation and Analytical Development SMEs in R&D to support and/or write documents/reports/laboratory instructions that are accurate and usable 

•    Work with Regulatory Groups in managing their regulatory submissions

•    Manage and support the document development, maintenance and change request process for multiple documents simultaneously 

•    Analyze documents and documents sets to identify opportunities for improvement 

•    Manage multiple, sometimes conflicting priorities

•    Other responsibilities as assigned 

QUALIFICATIONS:

•    Bachelor of Science degree in a Life or Physical Science

•    5 years related experience, or equivalent combination of education and experience; or 

•    Master of Science degree in a life or physical science plus publication and at least 1 year laboratory experience also considered

•    Excellent verbal and proven written communication skills

•    Able to handle multiple high priority documents/projects simultaneously 

•    Able to interact effectively at various levels within the organization, with our customers and other external contacts 

•    Working knowledge of CMC sections in Module 3 sections of regulatory filings and eCTD (electronic common technical document)

•    Fluent in MS Office and familiar with CMC documentation in the CTD format

•    Abel to quickly learn complex business processes and specialized terminology

•    Abel to work both independently and collaboratively with little supervision

•    Able to work in a changing environment with changing priorities