Regulatory Operations Manager

---

Job description

Piper Companies is currently looking for an experienced Regulatory Operations Manager near Philadelphia, PA to work for an innovative and growing pharmaceutical manufacturer. The Regulatory Operations Manager with be a key contributor in the development of new biologic oncology drugs.

Responsibilities for the Regulatory Operations Manager include:

• Manage, review, and support the completion of eCTD dossiers
• Responsible for formatting regulatory documents in CTD and eCTD format and managing life-cycle submissions, such as INDs, MFs, and BLAs in the US
• Oversee the implementation of new regulatory systems
• Provide training on preparing submission-ready documents, electronic publishing and submission
• Act as primary point of contact for external regulatory vendors

Qualifications for the Regulatory Operations Manager include:

• 10 years of experince within regulatory operations
• 5+ years of experince with regulatory submissions
• Hands on experince with regulatory systems preferably Please Review and Master Control
• Proficiency in Microsoft Office
• Hands on experince with biologic or large molecule pharmaceutical drug development
• B.S. in Regulatory Affairs or related field

Compensation for the Regulatory Operations Manager include:

• Salary Range is dependent upon experience.
• Comprehensive benefits package

Keywords

Regulatory Affairs, Manager, Philadelphia, Remote, IND Submission, SOP Development, Vendor Oversight, Please Review, Master Control Regulatory Module, Pharmaceutical, Biologic, Cell & Gene Therapy, Large Molecule, Oncology, FDA, Information Management eCTD Dossier, Dossier Content Manager