Offer summary

Qualifications:

M Pharm or B Pharm degree required., Strong understanding of regulatory guidelines in the pharma/biotech sector., Ability to review and prepare regulatory documents and submissions., Excellent communication skills for client interaction and query resolution..

Key responsibilities:

Review artworks and advise clients on regulatory guidelines.

Attend meetings with regulatory authorities to address client queries.

Prepare and review various regulatory modules and documents.

Coordinate with 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