Medifodil Hiring Regulatory Affairs

Regulatory Affairs Specialist 2–4 Yrs | Medifodil | India

Medifodil hiring Regulatory Affairs Specialist with 2–4 years experience. Life sciences graduates. Limited vacancies. Apply now.

Medifodil is expanding its regulatory operations and is inviting experienced Regulatory Affairs professionals to join its growing pharma and life sciences team. This opportunity is designed for candidates who want hands-on exposure to global regulatory submissions, dossier management, and end-to-end product lifecycle activities in a structured, compliance-driven environment. If you have strong CTD/eCTD expertise and want to build a long-term career in regulatory affairs, this role offers the right mix of responsibility and growth.

Company Overview

Medifodil is a smart pharma solutions organization supporting pharmaceutical and life sciences companies with regulatory, compliance, and documentation services across global markets. The company works closely with regulated-market submissions, helping clients navigate complex approval pathways while maintaining strict quality and compliance standards.

With a strong focus on regulatory excellence, Medifodil supports product development and commercialization across the US, EU, and other international markets. The organization is known for its process-driven approach, regulatory accuracy, and commitment to delivering compliant, submission-ready dossiers.

Job Role & Responsibilities

As a Regulatory Affairs Specialist, you will be responsible for supporting regulatory submissions and maintaining high-quality documentation throughout the product lifecycle.

Key responsibilities include:

• Compilation, review, and publishing of CTD and eCTD dossiers
• Supporting regulatory submissions for global markets including US, EU, and ROW
• Managing lifecycle activities such as variations, amendments, and renewals
• Coordinating with internal teams to collect, review, and finalize regulatory documents
• Ensuring dossiers meet current regulatory guidelines and submission standards
• Maintaining regulatory documentation in line with quality and compliance requirements
• Tracking submission timelines and supporting regulatory queries when required
• Assisting with regulatory intelligence and updates related to changing guidelines

Eligibility / Qualifications

Educational Background

• Degree in Pharmacy, Life Sciences, or a related discipline

Relevant courses include:
B.Pharm, M.Pharm, Pharmaceutical Sciences, Life Sciences, Biotechnology, Regulatory Affairs, Clinical Research

Experience Requirements

• 2 to 4 years of hands-on experience in Regulatory Affairs
• Practical exposure to CTD and eCTD dossier compilation and publishing
• Experience with regulatory submissions and product lifecycle management
• Familiarity with USFDA, EMA, and other global regulatory requirements preferred

Key Skills

• Strong documentation and regulatory writing skills
• Good understanding of submission workflows and regulatory compliance
• Ability to coordinate across teams and manage multiple submissions
• Clear written and verbal communication skills
• Detail-oriented with a strong focus on accuracy and timelines

Location & Salary

• Job Location: India (details to be discussed with shortlisted candidates)
• Employment Type: Full-time
• Salary: Competitive and aligned with industry standards based on experience

Application Process

Interested and eligible candidates are requested to share their updated CV via email.

Email: careers@medifodil.com

Shortlisted candidates will be contacted for further discussion and interview rounds.

Frequently Asked Questions (FAQs)

Is CTD/eCTD experience mandatory for this role?
Yes. Hands-on experience with CTD and eCTD dossier compilation and publishing is essential.

Which regulatory markets will this role support?
The role primarily supports US, EU, and ROW regulatory submissions.

Is this role suitable for freshers?
No. This position requires 2–4 years of relevant Regulatory Affairs experience.

Does the role involve lifecycle management activities?
Yes. The role includes variations, amendments, and other lifecycle-related regulatory activities.

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Company	Medifodil
Vacancies	Limited
Required Education	B.Pharm, M.Pharm, Life Sciences, Biotechnology
Experience	2–4 years Regulatory Affairs experience