Pharmaceutical Clinical Associates, LLC
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Union ,
NJ
• The position will be responsible for coordinating the deliverables and submitting (including
electronic) IND/NDA annual reports in accordance with FDA regulations and guidance.
• Collaborate with internal disciplines such as Clinical R&D, Nonclinical, Early Drug
Development, Chemistry, Manufacturing and Controls (CMC) and Regulatory Affairs to obtain
missing information and correct erroneous information that is intended for submission.
• Manage and develop up to 8 Regulatory Operations Staff Members.
• Develop and promote use of appropriate document policies and standards to
create "submission-ready" documents.
• Manage other Regulatory Operations department activities as required.
• Responsible for the quality of submissions generated by Regulatory Operations.
• Represent Regulatory Operations on project teams, driving timelines and deliverables
related to submission documents.
• Define electronic document/data management and submission processes. Responsible for
coordination, implementation and ongoing improvement of these processes.
• Develop training materials and provides training to internal and external personnel on
regulatory operations processes including document management and publishing systems.
• Respond to regulatory authorities regarding electronic submissions.
• Address internal or external inspections of documentation and publishing systems.
Experience and Skills:
• BS Degree with 5-7 years pharmaceutical experience.
• Knowledge and understanding of pre and post-marketing regulatory requirements in the US,
Europe and rest of world.
• Experience with an electronic document management system and/or workflows.
• Excellent organizational, communication and time management skills.
Additional Information:
Job Level: Any
Number of Openings: 1
Years of Experience:
Level of Education: Any
Salary: TBD
Starting Date : TBD
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Pharmaceutical Clinical Associates is always accepting employment inquiries from professionals interested in our opportunites. If you are interested in career opportunities at Pharmaceutical Clinical Associates please use our online resume formto apply. Pharmaceutical Clinical Associates is an Equal Opportunity Employer.
Union , NJ
Union , New Jersey
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