Job Description
Regulatory Submissions Senior Manager
Responsible for leading and managing Regulatory Operations staff who format and publish electronic documents for Regulatory submission deliverables, build submissions, and archive all Regulatory records pertaining to multiple Regulatory Applications such as INDs and amendments, CTAs and amendments, BLAs and amendments/supplements, MAAs and variations in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
Job Spec:
- Requires minimal guidance from direct manager.
- Functions as a contributor as needed.
- Provides support and backup to management as needed.
- Leads, manages, and develops staff who format and publish electronic documents for Regulatory submission deliverables, build submissions, and archive all Regulatory records.
- Ensures timely processing and delivery of Regulatory submission deliverables to Regulatory Agencies or partners.
- Analyzes resource needs and secures additional resources as needed.
- Ensures development and maintenance of Regulatory Operations standards and procedures in accordance with all applicable Regulatory regulations, guidance, and specifications.
- Provides guidance to multidisciplinary teams on developing submission structure strategies in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
- Manages vendors who support Regulatory Operations related tasks.
- Identifies regulatory system enhancement needs or technical issues and works closely with systems and technical support staff to identify, develop, and implement solutions.
- Assists with regulatory inspection activities.
Person Spec :
- Bachelor's Degree Preferred.
- 12+ Years.
- Requires knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
- Requires eCTD knowledge. Requires NeeS knowledge.
- Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills.
- Possess courage, energy and drive, strong operating skills, strong personal and interpersonal skills, and strong strategic skills.
- Working knowledge of Microsoft Office suite, Adobe Acrobat, ISIToolbox and/or A-Pulse, electronic document management systems (SharePoint preferred), eCTD publishing systems (eCTDManager preferred), eCTD validation and viewing tools, and XML are required. Working knowledge of eCTD authoring templates (StartingPoint) is preferred.
- Will be responsible for supervising staff.
Cv to Gerry Kennedy at The RFT Group at gerry@rftgroup.ie 01 2302400 www.rftgroup.ie