Job Description

Preferable Candidate : Pharma exp in Finished product ( Formulation)

JOB DESCRIPTION:

1. Dossier preparation, review submission in ACTD/ CTD/ Country Specific format for Product registration for local and export to ensure error free timely submissions as per marketing Dept. timeline.

2. To evaluate respond to any regulatory query, customer requirements that may arise from health authority so as to satisfy the query. Ensure accurate and timely responses to queries.

3. Review technical documents like process validation, AMV, Stability and composition etc, labeling, batch records, specification sheets or test methods for compliance with applicable regulations and policies.

4. To Co-ordinate / to visit with respective dept. in HO / Plant / ADL / R D for documents samples required for dossier / registration purpose. Co-ordination with API / PM vendors to resolve technical quires w.r.t. regulatory requirements.

5. Artwork Checking development for registration and commercial purpose as per regulatory requirement Ensure that all product artwork is updated when necessary and submitted in correct format and subsequent approved artwork is accurately recorded and communicated. Handling local FDA, DCGI and regulatory related activities.

6. Ensuring accurate recording and communication of regulatory submissions, correspondence with authorities and final approval to facilitate compliance.

Job Type: Full-time

Schedule: Day shift

Supplemental pay type: Yearly bonus

Experience: 3 to 8 years

Work Remotely: No

Job Type: Full-time

Pay: ?300,000.00 - ?700,000.00 per year

Benefits:

• Health insurance
• Provident Fund

Schedule:

• Day shift

Supplemental pay types:

• Yearly bonus

Ability to commute/relocate:

• Mumbai Suburban, Maharashtra: Reliably commute or planning to relocate before starting work (Required)

Experience:

• total work: 4 years (Preferred)

Job Types: Full-time, Permanent

Pay: ?22,000.00 - ?44,303.07 per month

Jadwal:

• Day shift

Tunjangan:

• Health insurance
• Provident Fund

Upah Tambahan:

• Yearly bonus

Experience:

• total work: 3 years (Preferred)

Work Location: In person