JAMP India Pharmaceuticals Hiring For Regulatory Affairs

Company: JAMP India Pharmaceuticals Pvt. Ltd.

Location: Ahmedabad

Department: Regulatory Affairs

Designation: Assistant Manager/Deputy Manager

Experience: 6 - 12 Yrs

Qualification: B.Pharma / M.Pharma

Key Roles:

✔Review quality Dossiers in CTD format for new Generic drug submissions, in-line with the guidance and templates.

✔Compile responses to deficiencies letters for the given portfolio of products.

✔Compile and review the Quality Overall Summary, Module 1 and Module 3 of all planned submissions.

✔Working closely with cross functional teams within the organization and third party teams and maintain good collaboration with all stakeholders CFT for the ongoing projects.

✔Manage a team of Associates on the day to day functioning of the assigned roles.

✔Provide leadership and mentoring to the Team Leads and Associates.

Prepare and submit due diligence reports of proposed dossiers to Senior Management in India and Canada.

✔Hands on experience in MS office (Word, Excel, PowerPoint).

Domain Knowledge:

✔Candidates with exposure in Dossier compilation and review for US,Europe or Canada market is mandatory.

Share your profile at sjani@jamppharma.com

Subject line "Profile for Assistant Manager/Deputy Manager - Regulatory Affairs".

JAMP India Pharmaceuticals Hiring For Regulatory Affairs