PSA Chemicals and Pharmaceuticals Walk-In Interviews for Regulatory Affairs Department from 14th – 23rd Aug 2026

PSA Chemicals and Pharmaceuticals is hiring a Regulatory Affairs Executive – FDA Liaisoning for its Regulatory Affairs Department at the company’s Head Office in Vashi, Navi Mumbai. The role is suited to experienced pharmaceutical professionals with expertise in finished formulation regulatory submissions, dossier management, FDA/Drug Regulatory Authority liaisoning, product registrations and regulatory compliance.

Walk-In Interview Details

Qualification

Essential:

• B.Pharm
• M.Pharm
• Pharm.D
• Equivalent pharmaceutical qualification

Preferred:

• M.Pharm
• MBA
• PG Diploma in Regulatory Affairs
• Equivalent qualification

Key Responsibilities

Regulatory Affairs: Prepare, review, compile and maintain regulatory dossiers for finished formulations and coordinate submissions according to country-specific requirements. The role also involves reviewing formulations, specifications, manufacturing processes, packaging materials, artwork and supporting documents for regulatory compliance.

FDA / Regulatory Authority Liaisoning: Coordinate and follow up with FDA, State FDA, Drug Regulatory Authorities and other competent authorities regarding applications, licenses, registrations, variations, permissions, renewals, NOCs and other regulatory matters.

Dossier Management: Support preparation and submission of dossiers for new product registrations, renewals, variations and post-approval changes. Coordinate administrative, technical, quality and manufacturing documentation and ensure consistency across dossiers, certificates, labels, cartons and package inserts.

Regulatory Documentation: Handle and coordinate documents including:

• Manufacturing Licenses
• GMP / WHO-GMP / EU-GMP Certificates
• CPP/COPP and FSC
• Certificates of Analysis
• Product Specifications
• Stability Data
• Validation Documents
• Site Master File
• Product Dossiers
• Artwork and Labelling Documents
• Free Sale / Export Certificates
• Regulatory Declarations and Undertakings

Export & International Regulatory Support: Provide regulatory support for international pharmaceutical markets, coordinate country-specific requirements with customers, agents and consultants, and assist with registrations, export approvals, NOCs, legalization/apostille and other regulatory submissions.

Internal Coordination: Work closely with QA, QC, Production, R&D, Supply Chain, Commercial and Management teams to collect regulatory documents, assess regulatory impact of proposed changes and ensure regulatory timelines are met.

FDA Liaisoning Responsibilities

The selected candidate will specifically support:

• Application submission and status follow-up
• Manufacturing and product permissions
• Regulatory approvals
• Regulatory queries and deficiency management
• Regulatory inspections and meetings
• Licenses, certificates, NOCs and permissions
• Regulatory correspondence and submission records
• Coordination with authorized consultants and agents

All interactions with regulatory authorities must be conducted under the authorization and instructions of management/Head – RA and in accordance with applicable laws and company procedures.

Required Skills

• Knowledge of pharmaceutical regulatory requirements
• Experience in regulatory dossier preparation
• Working knowledge of CTD/eCTD
• Finished formulation regulatory submissions
• FDA liaisoning and regulatory authority correspondence
• Product registration and export documentation
• Strong documentation and analytical skills
• Proficiency in MS Word, Excel and PowerPoint
• Excellent written and verbal communication
• Strong follow-up and coordination skills
• High attention to detail and accuracy
• Ability to work with internal and external stakeholders
• Confidential handling of regulatory information

Preferred Experience

Experience in the following areas will be advantageous:

• Pharmaceutical finished formulations
• FDA / State FDA liaisoning
• International regulatory markets
• Product registrations
• Export regulatory documentation
• Regulatory consultants and agents
• CTD/eCTD submissions
• Licensing, renewals, variations and post-approval changes

Key Performance Areas

The position will be responsible for ensuring:

• Timely preparation and submission of regulatory applications
• Timely responses to regulatory queries and deficiencies
• Effective follow-up with authorities and consultants
• Accuracy and completeness of regulatory dossiers
• Timely renewal of licenses and registrations
• Proper maintenance of regulatory records and trackers
• Compliance with regulatory submission timelines
• Effective internal and external coordination

Personal Attributes

Candidates should demonstrate a professional and responsible approach, strong ownership and follow-up ability, good interpersonal and liaisoning skills, attention to detail, confidentiality, ethical conduct and the ability to work independently under deadlines. Willingness to travel for regulatory meetings or inspections may also be required.

How to Apply

Interested candidates can attend the walk-in interview from 14th to 23rd August 2026, between 9:30 AM and 6:00 PM, at Vashi, Navi Mumbai.

Contact: Dr. Navneet Gadge
Phone: 8591920365

Note: The initial vacancy information states 4+ years of experience, while the detailed job description specifies minimum 3 years of relevant Regulatory Affairs experience. Candidates with 4+ years clearly meet the advertised requirement.