Jamp Pharma Hiring For Regulatory Affairs Dept

Jamp Pharma Hiring Details

1) Department: Regulatory Affairs 

Position: Assistant Manager / Deputy Manager

Experience: 6-12 yrs

Qualification: B.Pharma / M.Pharma

Location: Ahmedabad

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 having exposure in Dossier compilation and review for Australia market is mandatory and experience of US/Europe/Canada market will be added advantage.

Send profile at sjani@jamppharma.com

Jamp Pharma Hiring For Regulatory Affairs Dept