Assists with preparation of product development documents including gap analyses and clinical development plans.
Assists with preparation of regulatory submission documents including components of investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities, according to current government regulations and guidelines.
Conducts regulatory research to identify regulatory precedents and to support the preparation of orphan drug designation requests.
Performs quality checks on related documents.
Assists with submissions of other regulatory documents and other regulatory research as needed.
Assists clients, customers, or others with general information
Gathers, compiles, analyzes, and reports information.
Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence.

Should have minimum 6 months to 2 years of experience
Candidates with internship preferred
Should have CMC experience in small molecule.
Markets experience in EU, GCC, APAC would be preferred
Excellent interpersonal / communication skills.
Advanced skills in Microsoft Office Applications.
Good time and project management skills, preferred.
Strong analytical skills and attention to detail.
Ability to work both as a team member and independently and to understand and carry out detailed instructions.
Ability to interact with staff from multiple departments.
Ability to work concurrently on projects, each with specific instructions that may differ from project to project preferred.
Fluent in speaking, writing, and reading English.

We are passionate about developing our people, through career development and progression
supportive and engaged line management
technical and therapeutic area training
peer recognition and total rewards program
We are committed to building an inclusive culture – where you can authentically be yourself.

Regulatory Associate, EU Market, CMC Module 3

Key skills