Job Description

Responsibilities

Ensure product compliance with all relevant standards and regulations. Developing and executing global regulatory strategies for drug development and product lifecycle management. Leading regulatory submissions such as INDs (Investigational New Drug applications), NDAs (New Drug Applications), MAAs (Marketing Authorization Applications), and post-marketing variations. Interfacing with regulatory authorities to negotiate and resolve issues, facilitate approvals, and maintain compliance. Monitoring changes in regulatory requirements and ensuring internal processes and documentation are updated accordingly. Managing regulatory teams and collaborating with cross-functional departments including R&D, Clinical, Quality, and Legal.
Qualifications

Advanced degrees in life sciences, pharmacy, or related fields (e.g., PharmD, PhD, MSc). Extensive experience in regulatory affairs, including strategic and operational roles. Strong knowledge of global regulatory frameworks (FDA, EMA, ICH guidelines, etc.).
Job Type: Permanent

Pay: ?15,000.00 - ?40,000.00 per month

Benefits:

Food provided Health insurance Paid sick time
Work Location: In person