Base Medico Hiring Regulatory Officer

Regulatory Officer (BPharm/MPharm) – Formulation Plant | Vadodara

Meta Description:
Base Medico hiring Regulatory Officer with 1–2 yrs OSD formulation experience in Vadodara. B.Pharm/M.Pharm eligible. Salary open.

Base Medico Pvt. Ltd. is hiring an experienced Regulatory Officer for its formulation plant in Vadodara. This role suits candidates with 1–2 years of hands-on regulatory experience in OSD (tablet/capsule) pharmaceutical products. The position offers strong exposure to CMC documentation, dossier preparation, and regulatory project management.

Company Overview

Base Medico Pvt. Ltd. operates a formulation facility focused on high-quality OSD manufacturing supported by compliance, documentation integrity, and regulatory alignment. The organisation works with domestic and international clients, requiring precise technical documentation and up-to-date knowledge of global regulatory requirements. This is an ideal role for regulatory professionals who want deeper involvement in dossier compilation, validation documentation, and regulatory communication.

Job Role & Responsibilities

Regulatory Officer – Formulation (OSD)

Experience: 1–2 years (mandatory in OSD tablets/capsules)
Qualification: B.Pharm / M.Pharm

Key responsibilities:

• Compile and prepare dossiers and CMC documents per specific country guidelines
• Conduct technical review of product documents received from clients for registration
• Perform gap analysis of data required for dossier completeness
• Draft and review administrative sections of dossiers
• Review clinical and non-clinical sections for accuracy and completeness
• Communicate with clients to manage regulatory deliverables and clarify requirements
• Provide technical and regulatory support within the department
• Assist daily operations to ensure efficient regulatory workflow
• Update and maintain regulatory document repositories and servers
• Track and regularly update regulatory guidelines and country-specific requirements
• Prepare and draft validation protocols and reports (Process Validation, Hold Time Studies)
• Review final validation documents for regulatory and technical accuracy

Eligibility / Qualifications

Required Education:

• B.Pharm
• M.Pharm

Required Experience:

• 1–2 years in OSD formulation regulatory affairs (tablets/capsules)

Relevant courses (comma-separated): Pharmaceutics, Industrial Pharmacy, Pharmaceutical Management, Regulatory Affairs, Quality Assurance, Biopharmaceutics.

Preferred Skills:

• Strong understanding of CMC documentation
• Knowledge of dossier formats (CTD, ACTD)
• Ability to perform regulatory gap analysis
• Good communication for client coordination
• Familiarity with OSD manufacturing processes

Location & Salary

Work Location: Survey No. 570, Village Tundav, Savli–Vadodara Road, Vadodara, Gujarat – 391775
Salary: No bar for the right candidate (highly competitive)

Application Process

Interested candidates can apply by sending their updated resume to:
hr@basemedico.com
For queries, contact: 92743 95085

FAQs

Is OSD experience mandatory?

Yes. Regulatory experience focused on tablet/capsule formulation is required.

What documentation tasks will I handle?

Dossier development, CMC writing, validation protocols/reports, and regulatory communication.

Will I communicate with clients?

Yes. This role involves direct coordination with clients for regulatory project management.

Is there flexibility in salary?

Yes. Salary is open for highly skilled candidates.

Are freshers eligible?

No. Minimum 1 year regulatory experience in formulation is required.

Summary Table

Category	Details
Company	Base Medico Pvt. Ltd.
Vacancies	Regulatory Officer (Formulation Plant)
Required Education	B.Pharm / M.Pharm
Experience	1–2 years in OSD regulatory affairs