REGULATORY AFFAIRS SPECIALIST - RESEARCH & DEVELOPMENT - KOLKATA

Mendine Pharmaceuticals Pvt Ltd; Kolkata District; On-site; INR 600,000 - 900,000; Full time

Job summary

Mendine in Kolkata is seeking a Regulatory Affairs Specialist to ensure compliance of our oral liquid formulations with regulatory standards. You will monitor regulatory changes, prepare and submit documents to agencies, and guide internal teams on compliance across product registrations and clinical documentation.

The role requires strong analytical and communication skills, ability to coordinate submissions and meet deadlines, and liaison with regulatory agencies, audits, and endorsements as

Qualifications

• Regulatory affairs roles require strong analytical and problem-solving abilities.
• Excellent communication and coordination skills to interact with agencies.

Responsibilities

• Monitor regulatory changes and prepare/submission documents to regulatory agencies.
• Coordinate internal teams on compliance and liaise with regulatory bodies.

Skills

Regulatory affairs

Analytical thinking

Written & verbal communication

Submission coordination

Deadline management

Job description

REGULATORY AFFAIRS SPECIALIST - RESEARCH & DEVELOPMENT - KOLKATA

KOLKATA

Responsibility

A Regulatory Affairs Specialist's job description involves ensuring a company's products and operations comply with relevant regulations, laws, and guidelines. Responsible for monitoring regulatory changes, preparing and submitting documents to regulatory agencies, and providing guidance to internal teams on compliance. This role also includes assessing compliance, recommending remediation, and acting as a liaison between the company and regulatory agencies. Responsible for preparing and submitting various documents, including product registration dossiers, clinical trial documentation, Endorsement approval COPP product wise approval and other regulatory submissions. Co-ordination for external audit with external Regulatory Agency with Regularity guideline awareness.

Qualifications

Required Skill:Regulatory Affairs roles require a blend of technical and soft skills. Strong analytical and problem-solving abilities are crucial for interpreting regulations and addressing complex issues. Effective communication, including writing and presentation skills, is essential for interacting with regulatory bodies and internal teams. Additionally, strong skills are needed to coordinate submissions and ensure compliance with deadlines

Location:KOLKATA

Dead Line:

Company Detail

Mendine has always been a pioneer in development of oral liquid formulations, with its team of researchers and scientist along with most sophisticated instruments it has pioneered in oral liquid dosage forms which include solutions, syrups, suspensions, elixirs and concentrates.