Aculife Healthcare Hiring For Manager/Sr Manager–Regulatory Affairs

We Aculife Healthcare Private Ltd hiring for Manager/Sr. Manager–Regulatory Affairs (EU/ROW), based at Corporate office, Ahmedabad.

If required skills & experience matches with your profile, share your updated resume to saurabhkharya@aculife.co.in

Department: Regulatory Affairs

Qualification: B.Pharm, M.Pharm

No Of Position: 2

Designation: Manager/Senior Manager

Experience: 8+ Years

Geographic Location: Ahmedabad, Gujarat, India

Role & responsibilities:

Compilation and review of registration dossiers as per Country specific guidelines and

requirements.

Specific experience required for Latam American market including Brazil, Mexico. Should have to

work for EU market and hands on experience about the submission Management system.

Review of all Technical Documents (DMF, Product Development Report, BMR, BPR, Analytical

Method Validation Report, Specification-STP, Stability Report, BE Study Report etc.)

Compilation of deficiency responses of new product submission and Backlog dossier

To review the proposal for any post-approval changes as per the current regulatory guidance.

To prepare and submit the variation for post approval changes.

To communicate and follow up with overseas regulatory team /agent/ distributors to ensure timely

filing of new submission or variation.

To review various artworks & comments for ongoing commercial supply & products for the new

launch.

To prepare and maintain various registration Data base & updating at Central Depository

Preferred candidate profile:

Candidate must have 8+ years of core IRA experience in Latam and EU market can only apply.

Candidate should have good technical job knowledge of EU and other regulatory.

Should have good communication and interpersonal skills

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