Senior Regulatory Operations Manager
Proclinical is currently recruiting for a Senior Regulatory Operations Manager with a multinational biotechnology company located in Cambridge, MA. Coordinate all publishing deliverables, in line with the strategic direction of their assigned programs/products.
- Act as the primary point of contact for regulatory functions (i.e. GEM, CMC, Development, and Labelling).
- Partner with planning and tracking to ensure submission deliverables are incorporated and visible to all stakeholders.
- Ensure hand offs and deliverables from authoring community are on time and in line with the submission standards and expectations of quality.
- Drive deliverable timelines with RSM and authoring community and sets appropriate standards and expectations of quality.
- Identify and assess impact of agency guidance updates relevant to submission sciences, and drives innovative process change for improved efficiency.
- Drive change, responsibility for a wide range of initiatives as well as process efficiency and improvements.
- Primary point of contact with vendor for all operational activities.
- Oversee publishing deliverables to ensure successful execution of operational activities for assigned products
- Coordinate and track delivery of required content with content owners for routine submissions.
- Assist functional leadership to analyzing and assess performance of vendor-related activities against defined targets.
- Drive new concepts for analyzing data and promoting awareness of Regulatory Information Management strategies.
- Driver of quality of submission build, set submission standards and ensure vendor compliance with standards.
- Understand and communicate impact of Industry and Agency changes relevant to submission sciences, in partnership with vendor and driving innovative process change for improved efficiency.
Skills and Requirements:
- Bachelor's Degree (life sciences preferable, IT/Business acceptable) required but advanced degree is preferred.
- 6+ years pharmaceutical and regulatory experience (biotech products preferred), in addition to 4+ years of regulatory operations experience.
- 5+ years of experience in CTD or eCTD; SME in eCTD.
- Project management and Vendor Management qualification preferable.
- SME experience in regulatory operations processes.
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 Amanda Rivera at (+1) 267-435-8555 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.
Proclinical Staffing is an equal opportunity employer.