5++

Bachelors degree in chemistry, toxicology, product stewardship or related discipline required. Advanced degree preferred.

M.Sc / B.Pharm. Assess regulatory inspection citations from internal sites to identify and implement global corrective and preventive actions.

Working in partnership with the Client Engagement team, Medical Communications, and the Writing delivery team for a designated client group/therapeutic area (TA) / brand, this role will be responsible for delivering and supporting scientific excellence of Medical Communications services across their accounts

Must have broad understanding of the development of pharmaceutical products, regulatory and patent law globally. Patent and regulatory databases in different countries

Define and execute the discovery biology strategy across modalities small molecules, antibody, ADC, and cell & gene therapy in alignment with company goals.

Develop and execute quality and compliance monitoring activities for PS processes within area of expertise to support a robust GVP Quality Management System.

Participation in Trade Association calls in listening & learning, observer mode by leveraging the discussion and lessons learnt onto CMC Regulatory Intelligence databases.

This role provides regulatory leadership across the organization, ensuring compliance with FDA regulations and guidances, while driving continuous improvement in lifecycle management processes.

To ensure the compliance of internal/ external audit and to ensure timely adequate response of audit finding from the department to the auditor to close the issue.