Regulatory Affairs Specialist

UpMan Placements; Goa; Presencial; INR 600 000 - 900 000; Tempo integral

Resumo da oferta

A leading recruitment firm is seeking a Regulatory Affairs Specialist based in Goa. The ideal candidate will have 8-12 years of experience in Regulatory Affairs within the pharmaceutical industry and must possess a B.Pharm, M.Pharm, or M.Sc. Familiarity with GOA FDA regulations and quality assurance practices is preferred. This full-time position involves comprehensive regulatory compliance and documentation responsibilities.

Qualificações

• 8-12 years of experience in Regulatory Affairs in a pharmaceutical company.
• GOA FDA Mandatory.
• Prior experience in Quality Assurance is desirable.

Responsabilidades

• Prepare and submit regulatory submissions to health authorities.
• Handle product complaints from regulatory authorities.
• Maintain regulatory databases and documentation.
• Support the implementation of Regulatory SOPs and deliver training.
• Act as regulatory lead for the site to ensure compliance.

Conhecimentos

Regulatory Affairs

Quality Assurance

Compliance

Documentation

Training

Formação académica

B.Pharm / M.Pharm / M.Sc. or equivalent

Ferramentas

SUGAM

ONDLS

NSWS

SolTRAQs

Descrição da oferta de emprego

Overview

Recruiting || Market Mapping || Head Hunting || Niche Roles

Core Job Responsibilities

• Regulatory Submissions and Compliance: Prepare and submit applications such as additional product permission, layout approval, facility modification approval, technical person approval, test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes to State FDA; prepare and submit Test license NOC, WHO GMP applications, CPP applications for additional products; ensure timely submissions and approvals for all regulatory filings; evaluate technical and scientific data for regulatory submissions; liaise with health authorities for inspections, clarifications, and approvals; ensure compliance with D\u0026C Act, NDPS Act, Gazette Notifications, and internal SOPs.
• Product & Business Support: Handle product complaints from regulatory authorities, coordinating with QA, Legal, SCM, and Manufacturing for resolution; provide regulatory support for internalization and externalization of products; provide site CMC documents to international business team to support export registration.
• Documentation & Quality Oversight: Maintain and update regulatory databases, trackers, licenses, and approvals; review and track regulatory impact of quality documents such as change controls, deviations, FLQRs, and product certifications; evaluate and approve site change controls and Change Request evaluation forms; provide working standards/specifications and CoAs to regulatory authorities and internal teams; obtain NCC, Manufacturing & Marketing Certificates, and CMC documents to support institutional and international business; coordinate with Institutional business team and site team for documentation and to facilitate site inspection of tendering authority.
• Governance, SOPs & Training: Support the preparation, revision, and implementation of Regulatory SOPs and work instructions; deliver training on GMP, regulatory updates, and SOPs at the site level; approve SCNs from Corporate QA and review reports from regulatory authorities.
• Additional Responsibilities: Complete assigned trainings on time; perform other duties as assigned by the Regulatory Affairs leadership; act as the regulatory lead for the site, ensuring alignment with corporate and regulatory expectations.
• Position Accountability/Scope: Responsible for all regulatory activities for the manufacturing site mainly LL sites; ensures site compliance with applicable national regulations and Abbott standards; supports business continuity through proactive regulatory planning and execution.

Qualifications

• B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline.
• GOA FDA Mandatory
• Manager: Minimum 08 – 12 years of experience in Regulatory Affairs preferably with a multinational or leading Indian pharmaceutical company. Prior experience in Quality Assurance is desirable.
• Familiarity with regulatory platforms (SUGAM, ONDLS, NSWS, SolTRAQs) is desirable.

Senioriy level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance

Industries

• Pharmaceutical Manufacturing

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