Regulatory Assistant

Department : Regulatory Affairs Location : Surat, Gujarat, India Shift Timing : 2:00 PM to 11:30 PM IST (Supporting UK Business Hours) Reporting To : Regulatory Affairs Manager Employment Type : Full-Time

Job Purpose

The Regulatory Assistant will support the Regulatory Affairs team in maintaining compliance with UK MHRA requirements and other applicable pharmaceutical regulations. The role involves regulatory documentation management, submission support, compliance tracking, and coordination with internal departments to ensure regulatory activities are completed accurately and on time.

Key Responsibilities

- Maintain and organize regulatory documentation, dossiers, licenses, and product records.
- Support compliance with UK MHRA regulations, GDP, GMP, and company quality standards.
- Track regulatory commitments, deadlines, and approval statuses.
- Maintain regulatory databases and document management systems.
- Review and update Standard Operating Procedures (SOPs) and controlled documents.
- Support regulatory inspections, audits, and compliance reviews.
- Coordinate with Quality Assurance, Supply Chain, Commercial, and Operations teams on regulatory matters.
- Assist in reviewing product labeling, packaging artwork, and regulatory documentation.
- Monitor regulatory updates and communicate relevant changes to stakeholders.
- Ensure accurate record keeping and document archiving in accordance with company procedures.
- Support responses to regulatory authority requests and inquiries.
- Assist in maintaining inspection-ready documentation at all times.
- Participate in continuous improvement initiatives within the Regulatory Affairs function.

Qualifications

- Bachelor's Degree in Pharmacy (B.Pharm / M.Pharm), Life Sciences, Biotechnology, Chemistry, or a related scientific discipline.
- Regulatory Affairs certification will be an added advantage.





Experience

- 1-3 years of experience in Regulatory Affairs, Quality Assurance, Documentation, or Pharmaceutical Compliance.
- Experience within an MHRA-regulated pharmaceutical environment will be preferred.
- Familiarity with regulatory documentation and pharmaceutical quality systems.
- Freshers with excellent academic backgrounds and strong regulatory knowledge may also apply.

Knowledge & Skills

- Understanding of UK MHRA regulations.
- Knowledge of GDP and GMP requirements.
- Strong document control and record management skills.
- Excellent attention to detail and accuracy.
- Good organizational and time-management abilities.
- Strong written and verbal communication skills.
- Ability to work effectively within cross-functional teams.
- Ability to manage multiple tasks and meet deadlines.

Key Competencies

- Regulatory Compliance
- Documentation Management
- Attention to Detail
- Problem Solving
- Team Collaboration
- Planning and Organization
- Accountability
- Quality Focus
- Communication Skills
- Time Management

Compensation & Advantages

- Attractive remuneration package.
- Opportunity to work with UK pharmaceutical operations.
- Exposure to MHRA regulations and international pharmaceutical compliance standards.
- Professional growth and career development opportunities.
- Dynamic, collaborative, and learning-focused work environment.

Working Days

Monday to Saturday

Preferred Joining

Pay: ₹50,000.00 - ₹100,000.00 per month

Benefits :

- Health insurance
- Leave encashment
- Provident Fund

Ability to commute/relocate:

- Surat, Gujarat (Surat): Reliably commute or planning to relocate before starting work (required)

Education :

- Master's (required)

Language :

- English (required)

Location :

- Surat, Gujarat (Surat) (required)

Shift availability:

- Night Shift (required)

Work Location: In person

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