Regulatory Affairs Executive

Job Description – Regulatory Affairs Executive

Company: Briyosis Soft Caps Pvt. Ltd.
Location: Jarod, Gujarat
Department: Regulatory Affairs
Position: Regulatory Affairs Executive / Officer
Experience: 1–4 years in Pharmaceutical / Nutraceutical / Softgel industry

About the Role

We are looking for a detail-oriented and responsible Regulatory Affairs professional to manage regulatory documentation, product registrations, compliance activities, and coordination with internal departments and regulatory authorities.

The candidate should have good knowledge of pharmaceutical/nutraceutical regulations and documentation requirements, with exposure to softgel/soft capsule products being an advantage.

Key Responsibilities

• Prepare, review, and maintain regulatory documents and product dossiers.
• Support preparation and submission of documents for product registrations, licenses, renewals, and approvals.
• Ensure regulatory documents are accurate, complete, and submitted within timelines.
• Coordinate with QA, QC, Production, R&D, and Business Development teams for regulatory requirements.
• Review product information, specifications, labels, packaging materials, and technical documents for regulatory compliance.
• Maintain regulatory databases, submission trackers, licenses, certificates, and approval records.
• Monitor applicable changes in regulatory guidelines and communicate relevant requirements internally.
• Support responses to regulatory queries, deficiencies, and observations.
• Assist during regulatory inspections and audits by maintaining required documentation.
• Coordinate with customers/clients for regulatory documentation and product-related compliance requirements.
• Prepare documents such as product specifications, COAs, manufacturing details, declarations, certificates, and other supporting documents as required.
• Ensure proper document control and timely renewal of regulatory approvals and licenses.

Desired Knowledge

• Basic understanding of Pharmaceutical / Nutraceutical regulatory requirements.
• Knowledge of GMP and quality-system documentation.
• Familiarity with regulatory submissions and product registration processes.
• Understanding of labeling and packaging compliance.
• Good documentation and communication skills.
• Knowledge of softgel/soft capsule manufacturing will be an added advantage.
• Exposure to domestic and/or international regulatory requirements will be preferred.

Educational Qualification

• B.Pharm / M.Pharm preferred.
• Candidates from Pharmaceutical Sciences, Life Sciences, or related fields may also be considered.

Key Skills

• Regulatory documentation
• MS Office / Excel / Word
• Documentation control
• Attention to detail
• Communication and coordination
• Regulatory research
• Time management
• Problem-solving

Experience

1–4 years of relevant experience in Regulatory Affairs in a pharmaceutical, nutraceutical, food supplement, or softgel manufacturing company.

Freshers with relevant academic exposure may also be considered for an entry-level position.

Job Location

Jarod, Gujarat

Employment Type

Full-time

What We Offer

• Opportunity to work in the pharmaceutical/softgel manufacturing industry.
• Exposure to regulatory documentation and compliance activities.
• Professional growth and learning opportunities.
• Competitive compensation based on qualification and experience.

Pay: ₹150,000.00 - ₹250,000.00 per year

Benefits:

• Provident Fund

Work Location: In person