AGM / Sr. Manager - Regulatroy Affairs

Role & responsibilities :

• Reviewing, verifying, and processing of all technical documents for

accuracy before compilation or submission of dossiers as per USFDA &

PEPFAR requirements.

Trade dress, Q1 and Q2, bio-wavier, IIG clearance, MDD evaluation, Size

and Shape, Elemental iron, Residual solvent, Elemental impurity and

Exactable and Leachable impurity, Specifications [API and Finished drug

Product), Master Formula (with respect to Bio-waiver), Stability Protocol,

Labeling Information, Product development Report, Method Validation

Report, BMR and BPR etc.

meetings) and interact with members of all development project teams to

convey regulatory requirements and develop a strategy to meet pre-

assigned goals

assigning proper supplement category along with the data requirements

through TrackWise software.

network within the department along with updating them on most recent

regulatory / ICH guidance.

Approval Supplement (PAS).

to Deficiency / Queries within stipulated time frame i.e Initial filling

Complete response letter, Solicited and Unsolicited amendments.

with stakeholders ensuring receipt of the required documents and Review

and submission of responses to queries within stipulated time frame.

Market.

Skills Required

ectd, Method Validation