Regulatory Officer to Sr Officer

Base Medico Pvt. Ltd.; Vadodara; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Base Medico Pvt. Ltd. in Vadodara, Gujarat, is seeking a Regulatory Affairs Officer to Senior Officer with 1–3 years of regulatory experience and pharmacy qualifications. The role focuses on CTD/ACTD dossier preparation and regulatory submissions for Africa, LATAM, and ASEAN markets.

The company emphasizes regulatory compliance, robust documentation, and exposure to international markets, offering a path for long-term career growth in pharmaceutical regulatory affairs.

Qualifications

• 1–3 years of experience in pharmaceutical Regulatory Affairs.
• Hands-on experience with CTD and ACTD dossier preparation.
• Experience with regulatory submissions for multiple international markets (Africa, LATAM, ASEAN).

Responsibilities

• Prepare and compile CTD and ACTD dossiers for registrations.
• Handle regulatory submissions for Africa, LATAM, ASEAN markets.
• Coordinate with QA, QC, R&D, and production for dossier inputs.

Skills

Regulatory affairs

CTD/ACTD

Dossier preparation

Global submissions

Documentation accuracy

Education

B.Pharm

M.Pharm

Job description

Base Medico hiring Regulatory Affairs Officer to Sr Officer in Vadodara. B.Pharm/M.Pharm with 1–3 years experience eligible.

Base Medico Pvt. Ltd. is hiring Regulatory Affairs professionals for Officer to Senior Officer positions at its Vadodara manufacturing location. This opportunity is suited for pharmacy graduates with hands-on regulatory experience who are actively involved in dossier preparation and global regulatory submissions. The role offers direct exposure to emerging and regulated international markets and is ideal for candidates looking to build a long-term career in pharmaceutical regulatory affairs.

Company Overview

Base Medico Pvt. Ltd. is an Indian pharmaceutical company engaged in the development, manufacturing, and regulatory submission of quality pharmaceutical products for domestic and international markets. The company focuses on compliance-driven operations, robust documentation practices, and adherence to global regulatory standards.

With an expanding footprint across Africa, Latin America, and ASEAN regions, Base Medico continues to strengthen its regulatory affairs capabilities to support timely product registrations and lifecycle management. The organization emphasizes accuracy, regulatory intelligence, and continuous improvement, making it a strong workplace for regulatory professionals seeking practical exposure and career growth.

Job Role & Responsibilities

The Regulatory Affairs Officer to Senior Officer will be responsible for preparation, review, and submission of regulatory dossiers in compliance with country-specific requirements. This role requires strong technical knowledge of CTD and ACTD formats and the ability to manage submissions across multiple international markets.

Key Responsibilities

• Prepare and compile CTD and ACTD dossiers for pharmaceutical product registrations
• Handle regulatory submissions for Africa, LATAM, and ASEAN markets
• Coordinate with internal departments such as QA, QC, R&D, and production for dossier inputs
• Review regulatory documents to ensure accuracy, consistency, and compliance with guidelines
• Manage query responses and deficiency letters from regulatory authorities
• Support post-approval variations, renewals, and lifecycle management activities
• Maintain regulatory databases and submission trackers
• Ensure documentation is inspection-ready and audit-compliant
• Monitor changes in international regulatory guidelines and update internal teams accordingly
• Support senior regulatory staff in strategic submission planning

This role plays a direct role in expanding Base Medico’s international market presence while ensuring regulatory compliance and product quality.

Educational Requirements

Candidates must possess a pharmacy qualification from a recognized institution.

Relevant Courses (comma-separated):
B.Pharmacy, M.Pharmacy, Pharmaceutical Sciences, Regulatory Affairs

Experience Requirements

• 1 to 3 years of experience in pharmaceutical Regulatory Affairs
• Hands-on experience in CTD and ACTD dossier preparation
• Practical exposure to submissions for Africa, LATAM, and ASEAN regions
• Familiarity with country-specific regulatory requirements and guidelines

Required Skills

• Strong understanding of global regulatory submission processes
• High attention to detail and documentation accuracy
• Ability to manage multiple dossiers simultaneously
• Proactive approach and problem-solving mindset
• Good written and verbal communication skills

Location & Salary

• Job Location: Survey No. 570, Village Tundav, Savli – Vadodara Road, Vadodara, Gujarat – 391775
• Employment Type: Full-time
• Salary: Competitive and based on experience and current industry standards

Who can apply for this Regulatory Affairs position?

Candidates with B.Pharm or M.Pharm qualifications and 1–3 years of regulatory affairs experience can apply.

Which markets will I work on?

You will handle regulatory submissions for Africa, Latin America, and ASEAN regions.

Is this role suitable for freshers?

No. Prior hands‑on regulatory experience is mandatory.

Where is the job located?

The position is based in Vadodara, Gujarat.

Additional SEO Title Options

• Base Medico Hiring Regulatory Affairs Officer – Vadodara Pharma Jobs
• Regulatory Affairs Vacancy at Base Medico – CTD / ACTD Experience Required
• Base Medico Vadodara Regulatory Affairs Careers – Officer to Sr Officer