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.

• Review and regulatory compliance of Initial ANDA Documents like

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.

• Participate and represent as regulatory team in meetings (Level 1 and 2

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

convey regulatory requirements and develop a strategy to meet pre-

assigned goals

• Review and evaluation of change controls for regulatory impacts,

assigning proper supplement category along with the data requirements

through TrackWise software.

• Evaluation and good interpretation of Post approval changes.

• To train newly joined (freshers) with regulatory set-up and its associated

network within the department along with updating them on most recent

regulatory /ICH guidance.

• Review and Submission of supplements like CBE, CBE-30 and Prior

Approval Supplement (PAS).

• Review and submission of Annual Reports (ANDAs/NDAs).

• To expedite closure of review cycle of submitted ANDAs i.e Responses

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

• review comments, Discipline review letter, Information request letter,

Complete response letter, Solicited and Unsolicited amendments.

• Analyzing queries on submitted ANDA Designing corrective action plan

with stakeholders ensuring receipt of the required documents and Review

and submission of responses to queries within stipulated time frame.

• Labeling and SPL preparation as per RLD updates or new filing for US

Market.

• Well verse with eCTD and SPL software of Pharma ready solution