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Ctd Manager Jobs (NOW HIRING)

CMC Manager Location: 36 Columbia Rd., Morristown, NJ, USA, 07962 Duration: 12+ Months This ... Draft or update the technical registration dossiers (CTD Module III and QOS or equivalent) of ...

ADMIN ASSISTANT, CTD

San Diego, CA · On-site

$45K - $60K/yr

The ideal candidate will be collaborative, exercise good judgement, have a strong attention to detail and be committed to enabling high quality science by managing administrative processes for our ...

Rheumatologist

Orlando, FL · On-site

$256K - $330K/yr

This physician will be crucial in evaluating and managing patients with connective tissue disease-associated interstitial lung disease (CTD-ILD), working alongside pulmonology, transplant, and other ...

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CMC Regulatory Manager

Morristown, NJ • On-site

Us tech Solutions
IT Services • 1 - 5K employees

Contractor

Re-posted 14 days ago


Job description

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.

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About US Tech Solutions

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US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions.

Industry

It services

Company size

1,001 - 5,000 Employees

Headquarters location

Jersey City, NJ, US

Year founded

2000

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