Medifodil Smart Pharma Solutions is inviting applications from experienced Regulatory Affairs professionals and MICC (Medical Information Contact Center) Specialists with 2–5 years of experience. These full-time opportunities are ideal for candidates seeking growth in global regulatory submissions, pharmacovigilance, and medical information services within a compliance-driven pharmaceutical environment.
Both roles offer exposure to regulated markets (US, EU, UK) and align with international guidelines such as ICH, FDA, EMA, MHRA, and GVP, making them highly relevant for professionals aiming to strengthen long-term careers in regulatory affairs and drug safety.
Job 1: Regulatory Affairs Specialist (2–4 Years Experience)
Key Responsibilities – Regulatory Affairs Specialist
- Prepare, compile, review, and submit CTD, eCTD, and NeeS dossiers
- Support ANDA, NDA, DMF, IND, and MAA submissions
- Perform eCTD publishing including formatting, hyperlinking, bookmarking, and validation
- Manage lifecycle submissions such as variations, supplements, renewals, and annual reports
- Track regulatory submissions and maintain document management systems
- Coordinate responses to health authority queries and deficiency letters
- Ensure compliance with ICH, US FDA, EMA, MHRA, and global regulations
- Collaborate with QA, R&D, Clinical, PV, and Medical Writing teams
- Support regulatory audits and inspections
Qualifications – Regulatory Affairs Specialist
- B.Pharm / M.Pharm / MSc or equivalent in Pharmacy or Life Sciences
- 2–4 years of experience in Regulatory Affairs or Regulatory Operations
- Hands-on experience with global regulatory submissions and eCTD publishing
- Exposure to US, EU, and UK markets
Job 2: MICC Specialist (2–5 Years Experience)
Key Responsibilities – MICC Specialist
- Handle Medical Information (MI) inquiries via phone, email, web, IVRS, and digital platforms
- Provide accurate, balanced, and approved medical responses
- Identify, document, and triage AEs, SAEs, and Special Situations
- Capture and route Product Quality Complaints (PQCs) to Quality teams
- Ensure accurate documentation in MICC and safety databases
- Perform follow-ups and ensure timely case closure
- Maintain compliance with ICH, GVP, FDA, EMA, and internal SOPs
- Support audits, inspections, and process improvement initiatives
Qualifications – MICC Specialist
- Bachelor’s degree in Pharmacy or Life Sciences
- 2–5 years of experience in MICC, Medical Information, or Pharmacovigilance
- Hands-on experience with AE intake, MI handling, and PQC processes
- Familiarity with Argus, Veeva, CRM tools
- Strong communication and documentation skills
Benefits may include:
- Competitive salary aligned with industry standards
- Exposure to global regulatory and safety operations
- Professional development and compliance training
- Collaborative, quality-driven work culture
How to Apply
Eligible and interested candidates should email their updated resume/CV to:
Email: careers@medifodil.com
Subject Line (MICC Role):
Application for MICC Specialist – 2+ Years Experience