CMC Regulatory Manager

Us tech Solutions; Morristown (TN); On-site; USD 90,000 - 120,000; Full time

Job summary

Us tech Solutions is seeking a CMC Manager in Morristown, TN. The role involves leading the development of Chemistry, Manufacturing, and Control (CTD Module 3) documentation for regulatory submissions. The candidate will ensure that documents are of high quality and meet industry standards.

The ideal applicant will have a Bachelor’s degree and significant experience in regulatory environments. Key skills include excellent writing and analytical abilities, as well as CMC documentation experience. The position will be managerial in nature, coordinating with project teams on regulatory submissions.

Qualifications

• Bachelor’s degree with 4+ years of proven experience or Master's degree with 2+ years of proven experience.
• Experience in CMC/Module 3 documentation.
• Excellent writing skills are essential.

Responsibilities

• Lead the development of CTD Module 3 and QOS documents for submission.
• Align with project teams on strategy for product maintenance.
• Evaluate change requests to define technical requirements.
• Create or update technical registration dossiers.
• Maintain knowledge of current regulatory requirements.
• Coordinate responses to regulatory questions.

Skills

Experience in global CMC/Module 3 creation

Analyzing technical reports (manufacturing, analytical and stability)

Experienced in the US regulatory environment

Experience in post‑approval CMC changes

Excellent writing skills

Managing IT based scientific systems

Education

Bachelor’s degree with 4 or more years of proven experience

Master’s degree with 2 or more years of proven experience

Job description

Job Description

Title: CMC Manager

Duration: 12 Months

Location: Morristown, NJ 07962

Job Description:

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. In addition, the candidate might also support new product development projects.

Position Duties & Responsibilities

• 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 change.
• 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 Requirements

• Bachelor’s degree with 4 or more years of proven experience
• Master’s degree with 2 or more years of proven experience

Skill & Competency Requirements

• Experience in global CMC/Module 3 creation
• Demonstrated ability/experience analyzing technical reports (manufacturing, analytical and stability)
• Experienced in the US regulatory environment
• Experience in post‑approval CMC changes
• Excellent writing skills
• Demonstrated ability/experience managing IT based scientific systems

Additional Information

All your information will be kept confidential according to EEO guidelines.