Regulatory Affairs Associate Job

REGULATORY AFFAIRS ASSOCIATE needed for a CONTRACT opportunity with Yoh's client located in ROCKVILLE, MD.

WHAT YOU'LL BE DOING:

- Assist US Regulatory Lead to support regional regulatory activities (eg dossier development and submission, advisory committee meeting preparations)
- Provide and maintain Clinical Trial Application (IND) and Marketing Application (NDA and/or BLA) documentation support (eg annual reports, amendments) in collaboration with US Regulatory Lead
- Create and maintain product regulatory history documents through IMR database and appropriately archive all regulatory documents and agency communications
- Review US regional component of the Global Regulatory Plan and provide input to operational deliverables
- Ensure compliance with submissions to regulatory agencies (FDA)
- Collaborate to support site initiation
- Coordinate collection of functional documents in support of regulatory applications
- As appropriate participate in Global Regulatory Team (GRT) to support execution of regulatory strategy
- Coordinate QC of regulatory documentation (eg briefing packages)
- Provide primary authorship to routine regulatory correspondence (eg annual reports, investigator packages)
- Prepare cross-reference letters to support investigator initiated studies
- Complete regulatory forms to support agency communications (eg FDA form 1571)
- Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams
- Support process improvement initiatives, standards development, and metrics
- Assist in template development and maintenance
- Respond to specific requests from and communicate relevant issues to GRT
- Develop Regulatory Position with teams
- Actively support regulatory compliance
- Support the development and execution of GRT goals

WHAT YOU NEED TO BRING TO THE TABLE:

- Master's degree
- Bachelor's degree and two (2) years of regulatory and/or drug development experience
- Associate's degree and six (6) years of regulatory and/or drug development experience
- High school diploma and eight (8) years of regulatory and/or drug development experience

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

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