Specialist, Regulatory Affairs FDF

Centrient Pharmaceuticals Netherlands(1 year ago)

Gurugram, IndiaOnsiteFull TimeMedior$104,929 - $140,179 (estimated)Regulatory Affairs

About this role

An Associate in Regulatory Affairs (FDF) focused on supporting regulatory activities to secure global approvals and manage the lifecycle of registration dossiers for Centrient products. The role operates within a global regulatory environment and collaborates with cross-functional stakeholders to align regulatory strategy with business objectives.

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Required Skills

Dossier Preparation
Variations
Pharmacovigilance
CMC Evaluation
Regulatory Submissions
SOP Writing
Regulatory Intelligence
MDS Compliance
Cross-Functional Alignment
Communication

Qualifications

Degree in Pharmacy
Degree in Chemistry
Degree in Biomedical Sciences

About Centrient Pharmaceuticals Netherlands

centrient.com

Centrient Pharmaceuticals is a sustainable leader in the production of antibiotics, statins, and antifungals. The company focuses on delivering high-quality healthcare solutions while prioritizing environmental sustainability and social responsibility. Centrient is committed to addressing pressing health challenges such as antimicrobial resistance through innovation and collaboration, ensuring that medicines reach those who need them most. With a strong emphasis on corporate governance and sustainability initiatives, Centrient fosters a responsible approach to pharmaceutical manufacturing.