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