Associate RA ( Module 1, regulatory submission)

Associate RA (Regulatory Affairs)

Essential Functions

• Regulatory Document Preparation:

• Assist with the preparation of

  Module 1 documents

  and the collection of country-specific administrative forms.
• Aid in preparing various

  regulatory submission documents

  , including components of investigational new drug applications (INDs), new drug applications/marketing authorization applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, and marketing authorization transfers (MATs).
• Prepare responses to Health Authority queries and track Health Authority commitments.

• Tracking and Archiving:

• Maintain and update

  regulatory trackers

  , submission timelines, and status reports.
• Ensure proper archiving of submission documentation and compliance with internal SOPs.

• Regulatory Research & Support:

• Conduct

  regulatory research

  to identify precedents and support the preparation of orphan drug designation requests.
• Assist clients and customers with general information requests.
• Gather information from files, records, and contacts to prepare detailed reports and routine correspondence.

Qualification Requirements

• Education:

  A Master's degree in

  Pharmaceutical Sciences

  .

• Experience:

  A minimum of approximately

  2 years of experience

  in a regulatory, quality, or document management support role.

• Skills:

• Excellent

  interpersonal and communication skills

  .
• Advanced proficiency in

  Microsoft Office Applications

  .
• Good

  time and project management skills

  are preferred.