072 CMC Specialist

MAIN RESPONSIBILITIES

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

QUALIFICATION

6 + years of RA CMC required