Medifodil Hiring Regulatory Affairs Specialists
- Company Overview
- Job Role & Responsibilities
- Eligibility / Qualifications
- Location & Salary
- Application Process
- Why Join Medifodil?
- Frequently Asked Questions (FAQs)
- Summary Table
Regulatory Affairs Specialist – 4-7 Years | Medifodil
Medifodil is hiring Regulatory Affairs Specialists with 4-7 years experience. Compile eCTD dossiers, ensure compliance, and join a growing pharma team.
Medifodil, a leading smart pharmaceutical solutions provider, is actively seeking experienced Regulatory Affairs Specialists to strengthen its compliance and regulatory teams. This is an exciting opportunity for professionals with a minimum of 4-7 years of experience in regulatory submissions, particularly in preparing and reviewing eCTD dossiers to meet global standards.
Join Medifodil to contribute to innovative pharmaceutical projects while ensuring adherence to international regulatory requirements.
Company Overview
Medifodil is a forward-thinking pharmaceutical organization specializing in smart pharma solutions, focused on delivering high-quality, compliant, and globally marketable products. With an emphasis on innovation, technology, and regulatory excellence, Medifodil provides comprehensive services across drug development, regulatory affairs, and pharmaceutical compliance.
The company is known for fostering a collaborative work environment, where expertise in regulatory processes is valued and innovation is encouraged. Working at Medifodil offers exposure to multiple regulatory markets, including the USFDA, EMA, and other international authorities, enabling professionals to gain experience in a highly regulated environment.
Job Role & Responsibilities
Position: Regulatory Affairs Specialist
Experience: 4–7 years
Key Responsibilities:
- Compile, review, and maintain eCTD dossiers ensuring full compliance with global regulatory standards.
- Monitor changes in regulatory guidelines and implement necessary updates in submissions.
- Coordinate with cross-functional teams including R&D, Quality, and Production for timely regulatory submissions.
- Prepare regulatory reports, supporting documents, and submissions for various global markets.
- Ensure all submissions adhere to company SOPs, regulatory policies, and timelines.
- Provide guidance and mentorship to junior regulatory team members.
Eligibility / Qualifications
- Educational Qualification: B.Pharm, M.Pharm, or equivalent degree in life sciences/pharmacy.
- Experience: 4–7 years in regulatory affairs within a pharmaceutical or life sciences organization.
- Skills Required:
- Proficiency in eCTD dossier preparation and submission.
- Strong knowledge of global regulatory requirements (USFDA, EMA, ICH guidelines).
- Excellent communication, leadership, and teamwork abilities.
- Attention to detail and ability to work under tight deadlines.
Location & Salary
- Job Type: Full-time
- Location: [Company location/Head Office – can be specified during application]
- Salary: Competitive and based on experience
Medifodil offers a professional environment with opportunities for career growth and skill development in regulatory affairs and compliance.
Application Process
Interested candidates are requested to submit their updated resume to:
Email: Careers@medifodil.com
Website: www.medifodil.com
Apply immediately to join a dynamic team and contribute to pharmaceutical regulatory excellence. Include your detailed experience, educational certificates, and previous project experience in regulatory submissions.
Why Join Medifodil?
- Work in a cutting-edge regulatory environment handling global submissions.
- Opportunity to contribute to international pharmaceutical projects.
- Collaborate with a highly skilled team of professionals.
- Gain exposure to global regulatory processes and compliance standards.
- Supportive work culture emphasizing innovation, teamwork, and professional development.
Frequently Asked Questions (FAQs)
Q1. What is the required experience for this role?
A1. Candidates must have 4–7 years of experience in regulatory affairs, particularly with eCTD dossier preparation.
Q2. Which qualifications are eligible for this position?
A2. B.Pharm, M.Pharm, or equivalent life sciences/pharmacy degrees.
Q3. What is an eCTD dossier?
A3. An electronic Common Technical Document (eCTD) dossier is a standardized submission format for regulatory authorities to review and approve pharmaceutical products.
Q4. Can candidates from other countries apply?
A4. Yes, but preference will be given to candidates familiar with global regulatory standards.
Q5. How do I apply?
A5. Submit your resume via email to Careers@medifodil.com with the subject line “Application – Regulatory Affairs Specialist.”
Q6. What skills are essential?
A6. Knowledge of global regulations, eCTD submission experience, attention to detail, and strong communication and leadership skills.
Summary Table
| Category | Details |
|---|---|
| Company | Medifodil Smart Pharma Solutions |
| Vacancies | Regulatory Affairs Specialist |
| Required Education | B.Pharm, M.Pharm, Life Sciences Degree |
| Experience | 4–7 Years |
To apply for this job email your details to Careers@medifodil.com
