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Regulatory Affairs - APAC and Africa (WFH)

unlimited holidays - extra holidays - extra parental leave - long remote period allowed

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

Africa, APAC

Offer summary

Qualifications:

M Pharm or B Pharm, 2-5 years experience.

Key responsabilities:

Review artworks in compliance with local regulations
Prepare regulatory submission dossiers

Genedrift Startup https://www.genedrift.com/

11 - 50 Employees

See more Genedrift offers

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