REGULATORY AFFAIRS SPECIALIST
6-month renewable contract
The position is to provide support for upkeep of various database maintenance activities, and preparation and uploading of document into specific technical submission format.
POSITION DUTIES & RESPONSIBILITIES
• Maintenance of Client's Regulatory Information Database to ensure compliance with registration requirements in US;
• Assist with the compilation of documents necessary to support submissions by providing authoring support and appropriate document uploading into established submission format (eCTD);
• Provide QC document review as needed to ensure adherence to submission format requirements and functionality of document links;
• Assist with preparation of NDA Annual Reports by coordinating documentation with contributor groups.
Education Requirement(s): Bachelors Degree
Skill & Competency Requirements:
• Knowledge of Documentum-based database systems, ability to work independently under time pressure, excellent communication and general project management skills.
IMPORTANT NOTE for POTENTIAL US CANDIDATES: Our client expects its colleagues to be fully vaccinated against COVID-19. Colleagues are also expected to disclose their vaccination status and if fully vaccinated, provide proof of vaccination status to Occupational Medicine. Our client defines fully vaccinated in alignment with CDC which is two weeks after completing the two-dose vaccine regimen or two weeks after completing the one-dose regimen. Additionally, colleagues are also required to comply with state, local and customer requirements.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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