Hiring for the position of Regulatory Query Response Officer / Executive -Pharma for Ahmedabad

Job Description:

The job description is as below:

Purpose of the Role
To ensure timely, accurate, compliant, and scientifically justified responses to regulatory and customer queries related to pharmaceutical and medical device testing, in alignment with global regulatory and accreditation requirements.

Key Responsibilities

1. Regulatory Query Management
Receive, log, track, and respond to regulatory queries, including US FDA (483), DI queries, general correspondence, EU-GMP / PIC/S, ISO/IEC 17025 & ISO 9001 auditors, CDSCO, WHO-GMP, ANVISA, TGA, NABL assessments, Sponsor / MAH / Manufacturer technical queries. Ensure responses are technically sound, data-backed, and within committed timelines.

2. Scientific & Technical Justification
Draft scientifically justified responses related to test methods, validation/verification, OOS, OOT, deviations, investigations, Data Integrity (ALCOA+), instrument calibration & qualification, environmental monitoring & utilities data (if applicable). Coordinate with Analytical, Microbiology, and Engineering teams for factual inputs.

3. Compliance & Documentation
Ensure all responses comply with approved SOPs, test methods, and regulatory commitments. Laboratory accreditation scope (ISO/IEC 17025). Maintain complete traceability of queries, supporting documents, and final approved responses. Archive responses as part of quality records.

4. Cross-Functional Coordination
Interface with QA, QC, Microbiology, Validation, Regulatory Affairs (client or internal), IT/Data Integrity teams. Escalate critical compliance risks to QA Head promptly.

5. CAPA & Continuous Improvement
Identify trends in regulatory queries. Support initiation of CAPA, Change Control, or Risk Assessment where gaps are identified. Participate in management reviews and audit preparedness activities.

Confidentiality & Ethics
Ensure strict adherence to confidentiality agreements (NDA), data security and information integrity. Maintain impartiality as per public testing laboratory requirements.

Key Performance Indicators (KPIs)

% of queries responded within committed timelines

Zero critical observations due to inadequate responses

Regulatory acceptance rate of responses

Reduction in repeat or similar regulatory queries

JOB SPECIFICATION (JS)

Educational Qualification:
M.Pharm / B.Pharm / M.Sc / B.Sc (Chemistry, Microbiology, Biotechnology, Pharmaceutical Sciences)
Additional certification in Regulatory Affairs / Quality / ISO 17025 preferred

Experience:
3–8 years experience in Contract / Public Testing Laboratory, or Pharmaceutical or Medical Device QA / QC / RA.
Hands-on exposure to Regulatory audits, Regulatory correspondence and query handling.

Regulatory Knowledge (Mandatory):
ISO/IEC 17025:2017, ISO 9001, US FDA (CFR Parts 210, 211, 820 – awareness level), EU-GMP / PIC/S, WHO-GMP, NABL requirements.
Basic understanding of Medical Device regulations (ISO 13485, MDR – awareness).

Technical Competencies:
Strong understanding of analytical & microbiological testing, method validation/verification, OOS/OOT investigations, data integrity principles (ALCOA+).
Ability to interpret test data, audit observations, and regulatory expectations.

Behavioral & Professional Skills:
Excellent written communication (technical & regulatory English), strong analytical and documentation skills.
Ability to work under regulatory timelines, high attention to detail and compliance mindset.
Professional judgment and ethical integrity.

Authorization & Accountability:
Authorized to draft regulatory and customer responses.
Not authorized to commit regulatory positions or policy changes without QA Head approval.
Fully accountable for accuracy, completeness, and traceability of responses.

Training Requirements:
Induction training on ISO/IEC 17025, ISO 9001 Data Integrity, regulatory communication.
Periodic refresher training on global regulatory updates and audit response best practices

For further description please call Megha on 9377677857 or you can mail your candidature on megha@postaresume.co.in