Regulatory Affairs Specialist-Pesticides
ustechsolutions4
Contract
CMC Regulatory Manager
About this role
Company Description
US Tech Solutions is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit our website http://www.ustechsolutions.com/.We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, and we currently have a job opening that may interest you
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.
Qualifications
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
Requirements/Preferences
Education Requirement(s):
- 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
- Fluent in English
- Excellent writing skills
- Demonstrated ability/experience managing IT based scientific systems
Thanks & Regards,
Mayank Gupta, (M. Pharmacy)
(Lead Pharma Technical Recruiter)
10 Exchange Place, Suite 1710, Jersey City, NJ 07302
Direct: (412)-385-4143
Tel: (201) 524 9600 Ext 7797
Whats app: (412)-385-4143
Additional Information
All your information will be kept confidential according to EEO guidelines.
Frequently Asked Questions
Is the salary disclosed for the CMC Regulatory Manager position at ustechsolutions4?
The salary for this CMC Regulatory Manager role at ustechsolutions4 is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the CMC Regulatory Manager position at ustechsolutions4 located?
This CMC Regulatory Manager role at ustechsolutions4 is based in Morristown, Morristown, NJ, United States, NJ, us. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the CMC Regulatory Manager role at ustechsolutions4 full-time or part-time?
This is listed as a Contract position. It is posted as a CMC Regulatory Manager role at ustechsolutions4.
How do I apply for the CMC Regulatory Manager position at ustechsolutions4?
Click the "Apply Now" button on this page. You will be redirected to ustechsolutions4's official application portal hosted on smartrecruiters where you can submit your application directly.
When was the CMC Regulatory Manager job at ustechsolutions4 posted?
This CMC Regulatory Manager position at ustechsolutions4 was posted on Jan 2, 2020. Apply as soon as possible — early applications are often reviewed first.
CMC Regulatory Manager
ustechsolutions4
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