Regulatory Affairs Executive Vacancies at PIL Psychotropics Haridwar

Regulatory Affairs Executive Vacancies at PIL Psychotropics Haridwar – M Pharmacy, 2-4 Years Experience Required”

PIL Psychotropics India Limited (PIL) is currently seeking qualified candidates for the role of Regulatory Affairs Executive at their Haridwar location. This exciting opportunity is ideal for individuals with a background in M Pharmacy and 2-4 years of relevant experience. Located in the lush green surroundings of SIDCUL, Haridwar, this role promises a rewarding career in a dynamic pharmaceutical environment.

Company Overview

About PIL Psychotropics India Limited

Established in 1987, PIL Psychotropics India Limited (PIL) has grown into a renowned healthcare company addressing compassionate healthcare needs. Initially focused on psychiatry and topical products, PIL has expanded its portfolio to include various therapeutic segments like cardiovascular, gynecology, dermatology, anti-diabetic, antibiotics, anti-infectives, antihistamines, analgesics, acute painkillers, OTC/FMCG products, pet care products, and medicated soaps.

With three WHO GMP-approved manufacturing facilities in Haridwar, PIL is a well-known brand in the Indian market, especially in North India, Central India, and Gujarat. The company’s products are widely used in hospitals, nursing homes, and clinics and are exported to over 30 countries, including Africa and Southeast Asia.

Job Details

Role and Responsibilities

As a Regulatory Affairs Executive at PIL, you will be responsible for:

• Preparation, review, and timely submission of Dossiers in ACTD/CTD and Country Specific formats for the ROW market, African Countries, Asean Countries, Latam Countries, CIS Countries.
• Life cycle management for the products filed for registration
• Stay updated on regulatory guidelines and requirements for pharmaceuticals in ROW market, African Countries, ASEAN Countries, Latam Countries, CIS Countries.
• Coordinate with cross-functional teams to compile necessary documentation for submissions
• Collaborate with Quality Assurance and other departments to maintain regulatory compliance throughout the product lifecycle.
• Review of technical documents like AMV, PVP-PVR, FPS-MOA, COA, Stability, PDR, BMR, MFR, & Comparative Dissolution Profile Study.
• Preparation of the Draft Artwork, SMPC and PIL as per Regulatory guidelines
• Prepare Product Questionnaire as per Customers Requirements
• Coordinate with Liaoning team for State licensing Authority documents Like Product Permission, FSC, COPP & MMC.
• Other task Completion day by day assigned By the HOD

Qualifications

Must-Have

• Education: M Pharmacy
• Experience: 2-4 years in regulatory affairs
• Skills: High attention to detail, good interpersonal skills

Work Location

• Location: Haridwar, Uttarakhand, India
• Type: On-site, Full-time

How to Apply

To apply for the Regulatory Affairs Executive position at PIL Psychotropics Haridwar, please visit the official job listing.