Regulatory Manager

ProClinical is seeking a Manager to represent Regulatory Affairs for pharmaceutical development projects and marketed products. Successful candidate develop and communicate regulatory strategy on project teams and will work with development teams, identify and compile required documentation for regulatory submissions.

Responsibilities

• Ensure technical accuracy and regulatory compliance of all submissions for assigned projects are executed appropriately and submitted on time.
• Compile information into regulatory documents in consultation with subject matter experts.
• Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact company products and operations.
• Work with manager, effectively plan, organize, and participate in formal meetings with regulatory agencies as assigned.
• Supervise contractors as assigned for regulatory projects; collaborate on marketing application maintenance across multiple geographies and across business units as assigned.

Skills and Qualifications

• BS degree or equivalent in a scientific field.
• 6+ years' experience in Regulatory Affairs.
• Computer literate with knowledge of Microsoft Suite.
• Advanced knowledge of US and ICH regulations.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Nicole Aganon at (+1) 347-293-1161 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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