CMC Regulatory Specialist - Home Based - Minneapolis
Function Group: Quality/RA / RA Officer
To continue their ambitious growth, our partner (a Belgian-based pharmaceutical group), is currently looking to hire a CMC Regulatory Specialist for their US branch for submissions to the FDA. From your (home-) base in the US you will coordinate with the world-wide Product Development groups at both the organisation’s facilities as well as international contract development organisations. On a day-to-day basis you will review dossiers thoroughly and thus make sure that the content, format and overall organisation of the submission is in accordance with current US FDA guidelines and all other relevant regulatory directives. A challenging position for strong CMC regulatory professionals who would like to further develop their career and would like the flexibility that working from home gives.
To be more specific:
- You will be responsible for detailed content-review of dossiers for submission to the FDA. The scope includes areas related to formulation, analytical testing, stability, and manufacturing through packaging. Conformation to other regulatory standards such as ICH and wherever applicable, ISO standards must be adhered to
- You are expected to provide CMC advice during product development, responses to deficiencies, and post-approval changes
- Thus ensuring a detailed CMC review of ANDA and 505(b)(2) dossiers in accordance with US FDA standards of acceptability and essential completeness of eCTD modules (Modules 2 & 3)
- The technical review of dossier must allow for Acceptance to File (ATF), avoid any Refuse-to-Receive (RTR) comments from FDA, and confirm robustness assessment of the dossier, thereby leading to a meaningful prediction of FDA approval timelines
The ideal candidate:
- Hold a Master’s degree or higher in Science or a related field, with at least twelve years of experience in the US Generics pharmaceutical industry
- Is an accomplished professional with strong US FDA regulatory background and at least five years of experience in CMC review of scientific details required for presenting and compiling procedures, data, results, and commentary on pharmaceutical products for ANDA and 505(b)(2) submissions
- Has minimum of four years of hands-on experience in formulation development or analytical testing of pharmaceutical dosage forms related to oral and injectable dosage forms
- Has detailed understanding of how generic products are developed, manufactured, packaged and respective dossiers filed for approval. (Prior experience in US 505(b)(2) pathway will be given added consideration)
- Understands current regulatory requirements related to Quality by Design and interpretation of FDA guidances that are applicable to product development phase through commercialisation
- When it comes to areas of technical experience, can include CMC knowledge and good understanding of characterisation studies required for drug substance, finished product, and container closure systems, along with specifications setting and product performance
- Personality-wise is a detailed-oriented professional with analytical thinking, a team-player attitude, respect and understanding for cultural differences in different countries, efficient utilisation of time and resources, and adaptability due to differences in time zones
- Is flexible in committing to domestic and international travels of no more than 30% of total time
If you are looking for a exciting position with a great deal of flexibility with an ambitious producer of generic medicinal products, this is the position for you!
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Martin van der Velden
Principal Associate Biotech/Pharma division
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