CMC Specialist 321, 322

PL Group is seeking CMC Specialists to join our dynamic team and support the activities carried out in our Hub.

• Provide technical support (internally and during meetings with prospects) and content for the preparation of proposals
• Represent the company in forums and conferences where he/she acts as an expert on a subject
• Prepare or review CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files).
• Define document writing strategies.
• Define positions for variation folders.
• Assess the compliance of CMC documents according to the state of the art, current guidelines, local requirements and customer directives by performing gap analysis of regulatory documents.
• Advice on pharmaceutical development: analysis of validation, formulation or stability reports.
• Propose strategies for formulation, validation, choice of specifications, stability plan, bioequivalence.
• Be able to analyze and/or write scientific reports based on the raw data transmitted.
• Regulatory compliance: be able to compare analytical techniques and/or manufacturing processes between MA files and factory procedures.
• Conduct training sessions in CMC regulatory affairs or pharmaceutical development
• Carry out continuous regulatory monitoring and communicate them to the teams.
• Contribute to the support and training of newcomers and colleagues (methodology, feedback, tools).
• Manage customer relationship, project control and contractual aspects as project manager. The complete definition of the role of project manager is given in the corresponding job description.
• Apply internal processes and templates as well as good industry practices

1. Strategize, Prepare, review and dispatch of international market variations
2. Coordination with client
3. Change control Review
4. Managing and updating the internal and external tools
5. Timely update and maintain the trackers

• At least 10 years
• A CMC profile with international market quality variation experience is preferred. (Additionally EU quality variation experience and knowledge of variation module 1will be a Bonus)

1. Strong knowledge of the quality variation (module 3 writing)
2. knowledge of the variation module 1 writing
3. Capable to prepare and review quality documents
4. Capable to define and share variation strategies
5. Knowledge of the European/international guidelines
6. Capable to manage simple and complex quality projects
7. Capable to assess change controls
8. Good knowledge of MS office, share point