Job Description :
1. Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
2. Prepare CMC responses to health authority questions during development, registration and product lifecycle.
3. Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
4. Identify content, quality and/or timeliness issues with source documents, or any other potential au-thoring issues that may impact submission quality or timelines, as early as possible.
5. Keep knowledge up to date with regard to regulatory guidelines and requirements in all global re-gions as well as for new technical trends.
6. Actively participate as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
7. Establish and maintain sound working relationships with partners and customers.
8. Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions).
Apply now
1. Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
2. Prepare CMC responses to health authority questions during development, registration and product lifecycle.
3. Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
4. Identify content, quality and/or timeliness issues with source documents, or any other potential au-thoring issues that may impact submission quality or timelines, as early as possible.
5. Keep knowledge up to date with regard to regulatory guidelines and requirements in all global re-gions as well as for new technical trends.
6. Actively participate as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
7. Establish and maintain sound working relationships with partners and customers.
8. Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions).
Apply now
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