Category: Scientific & Clinical
Title: CMC Regulatory Associate
Location: Morristown, NJ
Schedule: 8am to 5pm Mon – Fri.
Type: Temporary 12 month contract
Start date: ASAP
- Under the broad guidance of the CMC product leads, the job entails supporting the
CMC Documentation team in the preparation of CMC registration documents.
- The person will be responsible for the creation and maintenance of regulatory CMC
documents in the controlled document management repository.
- The job purpose is to prepare technical CMC registration documents in order to
maintain the existing marketing authorization (i.e. dossier updates, variations, renewals,
response to deficiency letters, compliance gap closures) in various countries where
business is being conducted.
- Create/edit technical documents to ensure the on-time compilation of
high quality CTD Module 3 and QOS documents that are ready for submission
- Discuss and align with project team on strategy for maintenance activities for products under his or her responsibility
- Evaluate change requests with a goal of defining technical requirements according
to guidelines, evaluate and provide input on technical data to support product changes.
- Create or update the technical registration dossiers (CTD Module 3 and QOS or equivalent) of pharmaceutical/OTC products
- Maintain knowledge of current industry requirements and standards for CTD Module 3 and QOS or equivalent
- Work cross functionally to coordinate the preparation of draft responses to technical regulatory questions from health authorities
- Bachelor’s degree with 1 or more years of proven experience
- Associate’s degree with 3 or more years of proven experience
- Experience in global CMC regulatory
- Experience in creating CTD sections (Module 3)
- Excellent writing skills
- Demonstrated ability/experience managing IT based scientific systems
- Experienced in the US regulatory environment
- Experience in post-approval CMC changes
- Fluent in English (German and/or French speaking is a plus)
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.