Technical Regulatory Cmc Writer H/F Astek

Your mission (should you decide to accept it):

Your potential challenges will be various, depending on the clients' priorities. The list below gives you examples of our classic activities.

Your daily activities will be:

- The Technical Regulatory Writer is involved in the company's regulatory activities related to new & existing products, on a domestic or international basis. Activities focus on technical writing for Facilities, major and minor submissions....
- Write CMC, facility and equipment parts and new files for WW regulatory File.
- Manage and schedule with SMEs and Site conformance (and Production, Validation and Quality Assurance) the writing/review process to ensure timely completion.
- Ensure the coordination with the departments involved in the writing/review process.
- Write and support regulatory affairs Responses to Questions raised by Regulatory Authorities.
- Monitor that supportive data provided by other departments are compliant.
- Report significant issues.
- Manage the projects within all company/GRA tracking tools.
- Assess the change controls that relate to pure facilities and equipment matters or work with GRL teams for change controls impacting both CMC and facilities.