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

📌 Regulatory Affairs Executive (Jarod)
🏢 Briyosis Softcaps
📍 Jarod