Regulatory Affairs Specialist Jobs at Medifodil in India with CTD eCTD experience competitive salary global submissions career growth opportunities now
About the Company
Medifodil Smart Pharma Solutions Private Limited is a smart pharma solutions organization supporting pharmaceutical and life sciences companies with regulatory, compliance, and documentation services across global markets. The company specializes in regulated-market submissions and helps clients navigate complex approval pathways while maintaining high standards of quality and compliance.
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 culture, regulatory accuracy, and commitment to delivering submission-ready dossiers aligned with current global guidelines.
Job Details
- Job Title: Regulatory Affairs Specialist
- Experience: 2–4 Years
- Employment Type: Full-Time
- Job Location: India (final location to be discussed with shortlisted candidates)
- Industry: Pharmaceutical / Life Sciences / Regulatory Affairs
- Vacancies: Limited
Job Description
Medifodil is expanding its regulatory operations and is inviting experienced Regulatory Affairs professionals to join its growing pharma and life sciences team. This role is designed for candidates seeking hands-on exposure to global regulatory submissions, dossier management, and complete product lifecycle activities within a structured, compliance-driven environment. Regulatory Affairs Specialist Jobs at Medifodil
The position offers an opportunity to work on US, EU, and ROW submissions while developing strong expertise in CTD and eCTD documentation. Candidates with a passion for regulatory compliance and long-term career growth in Regulatory Affairs will find this role highly rewarding. Regulatory Affairs Specialist Jobs at Medifodil
Skills/Qualifications
Educational Background
- Degree in Pharmacy, Life Sciences, or a related discipline
- Eligible qualifications 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 in regulatory submissions and product lifecycle management
- Familiarity with USFDA, EMA, and other global regulatory authorities preferred
Regulatory Affairs Specialist Jobs at Medifodil
Key Responsibilities
- Compile, review, and publish CTD and eCTD dossiers
- Support regulatory submissions for US, EU, and ROW markets
- Manage lifecycle activities including variations, amendments, and renewals
- Coordinate with cross-functional teams to collect and finalize regulatory documents
- Ensure all submissions comply with current regulatory guidelines and standards
- Maintain accurate regulatory documentation in line with quality requirements
- Track submission timelines and assist in responding to regulatory queries
- Support regulatory intelligence activities and monitor guideline updates
Regulatory Affairs Specialist Jobs at Medifodil
Benefits/Perks
- Competitive salary aligned with industry standards
- Exposure to global regulatory markets and submissions
- Structured and compliance-focused work environment
- Opportunity to work on end-to-end regulatory lifecycle activities
- Professional growth in a specialized regulatory services organization
Regulatory Affairs Specialist Jobs at Medifodil
Why You Should Join
- Work on regulated-market submissions for US, EU, and international regions
- Gain deep expertise in CTD and eCTD publishing and lifecycle management
- Be part of a growing regulatory team with process-driven practices
- Build a stable and long-term career in Regulatory Affairs
- Contribute to high-impact regulatory projects across multiple markets
Regulatory Affairs Specialist Jobs at Medifodil
Frequently Asked Questions (FAQs)
Is CTD/eCTD experience mandatory for this role?
Yes. Hands-on experience in 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 position suitable for freshers?
No. This role requires 2–4 years of relevant Regulatory Affairs experience.
Does the role involve lifecycle management activities?
Yes. The role includes variations, amendments, renewals, and other lifecycle-related regulatory activities.
How to Apply
Interested and eligible candidates should share their updated CV via email.
Email: careers@medifodil.com
Shortlisted candidates will be contacted for further discussions and interview rounds. Regulatory Affairs Specialist Jobs at Medifodil
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