Consultant, Regulatory CMC
We are looking for an experienced regulatory CMC consultant to join our expanding regulatory team. This position will develop Regulatory CMC strategies and guide client teams in execution of these strategies. A successful candidate will bring exceptional interpersonal communication, a flexible attitude, and a proven record in regulatory interactions with global Health Authorities.
- Independently manage multiple Regulatory CMC (Chemistry Manufacturing and Controls) projects by establishing timelines, quality and resource objectives
- Develop Regulatory CMC strategies and guide client teams in execution of these strategies
- Prepare (as lead author) and/or review Regulatory submissions including INDs, CTAs, IMPDs, NDAs, BLAs, and MAAs
- Author and/or review annual reports, drug master files, amendments and supplements.
- Author and/or review FDA meeting requests and briefing documents; prepare clients for FDA meetings and have direct interactions with the health authorities
- Work on a variety of client engagements with an aim to increase efficiency, success and seek out business development opportunities
- Bachelor’s degree in life science; advance degree is a plus
- 6-10 years of experience in a biotech or pharma setting in either small molecules, proteins, monoclonal antibodies, cell therapy, or gene therapy
- Broad experience in Regulatory CMC including US investigational applications, clinical trial applications, global marketing authorizations and post approval life cycle management from both a strategic and executional level
- The ideal candidate will also have experience supporting program level strategic planning activities spanning from pre-IND through marketing approval
- Deep understanding of life sciences and of regulations and guidance for biotech and pharma products
- Excellent oral and written communication and presentation skills
- Client Focused approach to work
- Highly proficient in MS Word, Excel, and PowerPoint. MS Project is a plus