Sr. Manager/AGM-Regulatory Affair

Navlakha Management Services; Mumbai; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Navlakha Management Services in Mumbai seeks a Sr. Manager / AGM Regulatory Affairs (US Market) with 12-18 years of experience to lead US FDA submissions, ensure compliance, and manage post-approval changes for ANDAs/NDAs.

The role involves coordinating with development teams to communicate regulatory requirements and develop strategies to meet project goals. The candidate will review critical regulatory documents, prepare SPLs, labeling, and CBE/PAS submissions, and supervise regulatory

Qualifications

• 12-18 years of experience in Regulatory Affairs
• Experience with US FDA requirements and ANDA submissions
• Experience in regulatory strategies and post-approval changes

Responsibilities

• Review technical documents for accuracy before dossier submission per USFDA/PEPFAR
• Ensure regulatory compliance of ANDA documents and related artifacts
• Communicate regulatory requirements in cross-functional teams to meet project goals
• Evaluate change controls for regulatory impact and categorize supplements
• Prepare and submit labeling, SPL, and reference listed drug updates
• Train new hires on regulatory processes and guidelines
• Submit annual reports for ANDAs/NDAs and respond to regulatory queries

Skills

Regulatory affairs

US market

ANDA submissions

Regulatory compliance

Post-approval changes

Change controls

Labeling

SPL

QA review

Education

B.Pharm / M.Pharm / M.Sc.

Tools

TrackWise

PharmaReady Solution

eCTD

Job description

Job Title: Sr. Manager / AGM Regulatory Affairs (US Market)

Department: Regulatory Affairs

Industry: Pharmaceutical / Pharma

Job Location: Mumbai

Experience: 12-18 Years

Qualification: B.Pharm / M.Pharm / M.Sc. or equivalent relevant qualification

Job Description:

We are looking for an experienced professional in Regulatory Affairs US Market to handle ANDA submissions, regulatory compliance, post-approval changes, supplements, and regulatory query responses in accordance with USFDA requirements.

Key Responsibilities:

• Review, verify, and process technical documents for accuracy before compilation or submission of dossiers as per USFDA and PEPFAR requirements.
• Review and ensure regulatory compliance of initial ANDA documents, including Trade Dress, Q1/Q2, Bio-waiver, IIG Clearance, MDD Evaluation, Size and Shape, Elemental Iron, Residual Solvents, Elemental Impurities, Extractables and Leachables, API and Finished Drug Product Specifications, Master Formula, Stability Protocol, Labeling Information, Product Development Report, Method Validation Report, BMR and BPR.
• Represent the regulatory team in Level 1 and Level 2 meetings and coordinate with development project teams to communicate regulatory requirements and develop strategies to achieve project goals.
• Review and evaluate change controls for regulatory impact, assign appropriate supplement categories, and identify data requirements using TrackWise software.
• Evaluate and interpret post-approval changes.
• Train newly joined employees on regulatory processes, departmental systems, and the latest regulatory and ICH guidelines.
• Review and submit supplements, including CBE, CBE-30, and Prior Approval Supplements (PAS).
• Review and submit Annual Reports for ANDAs/NDAs.
• Ensure timely closure of ANDA review cycles, including responses to Initial Filing Review Comments, Discipline Review Letters, Information Request Letters, Complete Response Letters, and solicited/unsolicited amendments.
• Analyze queries on submitted ANDAs, develop corrective action plans with stakeholders, coordinate the required documentation, and ensure timely submission of responses.
• Prepare labeling and Structured Product Labeling (SPL) as per Reference Listed Drug (RLD) updates or new US Market filings.
• Work with eCTD and SPL software, including PharmaReady Solution.