Offer summary

Qualifications:

M Pharm or B Pharm degree required., 2-5 years of experience in regulatory affairs or related fields., Strong understanding of regulatory guidelines for APAC and Africa., Excellent communication skills for client interaction and meetings..

Key responsibilities:

Review artworks according to local regulatory guidelines and advise clients.

Attend meetings with regulatory authorities to address client queries.

Prepare and review various regulatory modules and documents.

Coordinate with internal departments to ensure project updates and compliance.

Job description

This is a remote position.

Review of artworks in accordance with local country regulatory guidelines and advising customers on the best 

Advising clients on Pre and Post Submission Dossiers Guidelines and application process.

Attend PreSubmission Meeting with Regulatory Authorities to resolve client queries and understand applicable guidelines. 

Review and Prepare Module 1 / Administrative Documents

Review and Prepare Module 4 and Module 5 according.
Review and Prepare Module 2 and Module 3.

Addressing and resolving regulatory queries pertaining to all modules of a ACTD/CTD.

Coordinate with related departments and group companies to ensure all projects are updated at all times across the company's internal systems. 
Attending to pre-sale and post-sale queries from customers and regulatory authorities.
Review of technical information pertaining to BE/BA studies.
Prepare Periodic Safety Update Reports. 
Preparation of therapeutic rationale and justification for fixed-dose combinations.
Literature search for clinical studies and non- clinical data for dossier submission and query resolution. 
Prepare and review Regulatory Roadmaps and Intelligence reports