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CMC Manager
Ref No.: 18-00410
Location: Morristown, New Jersey
Position Type:Contract
Start Date: 06/28/2018

The CMC Documentation Team is responsible for the development of Chemistry,
Manufacturing and Control (Module 3) documentation for the commercial products within the portfolio.

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.

- Lead the development of 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, and evaluate and provide input on technical data to support the
- Create or update the technical registration dossiers (CTD Module 3 and QOS or
equivalent) of pharmaceutical 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 including writing of expert statements and scientific justifications

Education Requirement(s):
- Bachelor's degree with 2 or more years of proven experience
- Master's degree with 1 or more years of proven experience

Skill & Competency Requirements:
- Demonstrated ability/experience developing and running effective business processes
- Demonstrated ability/experience managing IT based scientific systems
- Experience in global CMC/Module 3 creation

Preferences: (list nice-to-haves such a specific knowledge items, certifications, skills, abilities, etc.)
- Experienced in the US regulatory environment
- Experience in post-approval CMC changes
- Fluent in English (German and/or French speaking is a plus)

Travel Requirements: (if applicable)