REMOTE Regulatory Submissions Specialist

Proclinical is currently recruiting for a REMOTE Regulatory Submissions Specialist with a pharmaceutical company located in Worcester, MA.

Job Responsibilities:

• Act as a liaison between the Regulatory Affairs Clinical and Non-clinical, Regulatory Operations and project management teams for submission content planning
• Lead key regulatory activities, including planning, writing, and reviewing of documents necessary to support regulatory submissions, meeting requests, briefing packages, and responses to queries from regulatory agencies.

• Perform QC of submissions and maintain required supporting documentation (e.g. email, planners, QC documentation)
• Archive submissions in electronic repository
• Perform Registration Management activities, as necessary

Skills and Requirements:

• Bachelors Degree required - 4-5 years experience preferred
• Pharma Submission Management/ Publishing experience required
• submission publishing IND, NDA, ECTD familiarity required
• US/CAN submission background required
• Working knowledge of FDA, EU, ICH and ISO guidelines to ensure submission documents meet or exceed sponsor and regulatory requirements and guidance
• Project management
• Experience working in a document management system such as Veeva Vault, CARA, Documentum. Experience working with a regulatory publishing tool such as DocuBridge, Insight Publisher, or eCTDXPress. Strong proficiency in Microsoft Office Suite (Word, Excel) preferred

If you are having difficulty in applying or if you have any questions, please contact Miranda Gilmer at 570-277-7065. ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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