Analytical Regulatory Group Expert - Pharma

For a prestigious international company in the pharmaceutical sector, Randstad Italia is looking for an:

Analytical Regulatory Group Expert

The “Analytical Regulatory and CMC Science” Unit is providing Regulatory support and coordination on analytical topics, including improvement in pharmacopoeial compliance, and support improvement in the quality of the analytical documentation for biological products).

It is also proactively monitoring new analytical requirements by Regulatory Authorities and cross check discrepancies among different pharmacopoeial requirements, ensuring that methods, technologies, and validation are compliant/aligned to latest regulatory expectation. Finally, it is providing Scientific support through matrix interaction with different Functions.

Responsabilità

The candidate will support all these activities in the physico-chemical field analytical methods for QC purpose (development, validation and in routine activity) and physico-chemical characterization for both early Phase, late Phase, and marketed products.

In particular, the candidate will have the following responsibilities:

-Coordination on analytical topics for Regulatory submissions

-Review and drafting of Regulatory dossiers

-Promote harmonization of file requirements, both new registrations and changes

-Actively support Regulatory implementation of LCM changes 

-Identify and communicate implications for analytics of pharmacopoeial updates

-Provide technical and scientific expertise as member of inter-functional teams 

-Identify gaps, plan action, drive & monitor mitigation execution to ensure methods, technologies and validation are compliant/ aligned to latest regulatory expectation 

Professional background experience:

-Degree in Life Science is required (Degree in Chemistry, Biochemistry, Biology, Pharmaceutical Chemistry, or equivalent)

- years of experience in senior roles of analytical development and validation.

-Strong knowledge of regulatory requirements.

-An experience in physico-chemical characterization method is a plus

- ability to collaborate and negotiate solutions in a matrix environment and interacting with different functions/stakeholders in the organization

-Problem solving skills 

- Excellent skills in writing, oral, interpersonal communication, and presentation (English)

We offer a temporary maternity leave full time contract

Work area: Roma Est

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