Regulatory Document Specialist, Development QA
Newark Metro Area, NJ
Responsibilities will include, but are not limited to, the following:
Compile the required CMC documentation from regulatory filings, CROs and Medical Affairs to facilitate QP Certifications.
Maintain and organize IMP documentation database with the current most study and CMC regulatory documentation.
Liaise with functional source areas (Medical Affairs, CMC, Regulatory, SMEs) to ensure the documentation provided are appropriate and supply chain lists are current.
Revise or create procedures to manage the regulatory documentation required to ensure compliance to our QP certification commitments.
Assess global standards/policies and emerging regulations.
Must be skilled in planning and organizing, decision-making, and building relationships.
Able to effectively multi-task and when to escalate to management.
May represent Quality Operations on project teams, driving timelines and deliverables related to QP certification documents.
Other responsibilities related to the above within Development QA, as assigned.
BA/BS Degree, minimum of 3 yrs. pharmaceutical industry experience, prior Regulatory Operations experience and global clinical supplies preferred
Must have advanced knowledge and experience with preparing or reviewing CMC sections of the regulatory filings and Global Heath Authority approval requirements/documentation for investigational and commercial products.
Must have thorough knowledge of the Pharmaceutical Development Process as evidenced by bringing multiple INDs through to successful NDA approval. Knowledge of multiple pharmaceutical dosage forms (Solids /Parenteral etc.) would be considered an advantage.
Must provide guidance to other employees in the interpretation of regulatory requirements and support QP inquiries/requests, as needed.
Knowledge and experience in regulatory or CRO working with clinical submissions/filings, applications, and approvals preferred.
Knowledge and experience working with Qualified Person to facilitate product release preferred.
Knowledge of IND, NDA, MAA, CTD requirements and guidelines, both paper and electronic
Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
Technical knowledge of electronic publishing systems and software
Proficiency with MS-Office Suite and Adobe Acrobat applications
Knowledge of Electronic Document Management Systems and eCTD content
Self-starter with superior time management skills, and ability to work independently or in teams
Strong attention to detail