Regulatory Affairs Associate

 

Job Length: 6 months

Job Summary: Individual to assist in planning, review and preparation of investigational new drugs (INDs), new drug applications (NDAs), Biologic License Applications (BLAs), and all related annual reports, DMFs, amendments, supplements, and continued maintenance of approved marketed products.

Job Responsibilities:

• Support the compilation, development, and maintenance of US and Ex-US filings
• Track regulatory project status and informational documents
• Coordinate required documentation in coordination with senior CMC Lead
• Creating timelines and tracking deliverables for on-time submissions
• Interfacing with global regulatory partners and internal cross functional teams
• Attending relevant functional area and project team meetings as required

Job Requirements:

• Bachelors in a scientific discipline
• Minimum of 3-6 years Regulatory Affairs experience required; biologics experience required.
• Early and late drug development Biologics experience a must.
• Clear understanding of content and organization of regulatory submissions in eCTD format, as well as ICH and FDA Guidance
• Experience with global regulatory submissions (INDs, CTAs, MAAs, DMF’s)
• Excellent written and verbal communication skills
• Attention to detail, organizational skills, and a demonstrated ability to prioritize multiple projects
• Motivated, self-starter, able to work independently with minimal supervision