MEDIFODIL Smart Pharma Solutions has announced a new hiring opportunity for the position of Regulatory Affairs Specialist in Hyderabad, Telangana. This role is ideal for pharmaceutical professionals with experience in regulatory affairs and global submission processes.

The company is looking for experienced candidates who can support regulatory submissions, documentation, and lifecycle management activities while ensuring compliance with international regulatory guidelines.

If you have experience working with regulatory dossiers, eCTD submissions, and regulatory compliance for global markets such as the US and EU, this could be a strong career opportunity in the pharmaceutical regulatory domain.

Author: Pharmabharat Editorial Team

Job Details

Company Name: MEDIFODIL Smart Pharma Solutions

Job Title: Regulatory Affairs Specialist

Department: Regulatory Affairs

Job Location: Hyderabad, Telangana, India

Employment Type: Full-Time

Work Mode: On-site

Experience Required: 3–6 Years

Roles and Responsibilities

The Regulatory Affairs Specialist will be responsible for managing regulatory submission activities and supporting global regulatory operations. Key responsibilities include:

• Preparing, compiling, reviewing, and submitting regulatory dossiers in CTD, eCTD, and NeeS formats
• Supporting regulatory submissions such as ANDA, NDA, DMF, IND, and MAA
• Performing eCTD publishing activities including formatting, hyperlinking, bookmarking, validation, and quality checks
• Ensuring regulatory submissions are accurate and completed within defined timelines

Module Documentation Responsibilities

• Supporting preparation of Module 3 documentation including manufacturing, control, and stability data
• Assisting with Module 5 clinical documentation and clinical study reports
• Coordinating with CMC, clinical, and medical writing teams for dossier compilation

Regulatory Compliance

• Ensuring compliance with global regulatory guidelines including ICH, US FDA, EMA, and MHRA
• Monitoring regulatory updates and assisting with implementation of regulatory changes

Post Approval Lifecycle Management

• Supporting variations, amendments, renewals, and regulatory supplements
• Maintaining regulatory trackers, submission logs, and document management systems
• Assisting with responses to regulatory authority queries and deficiency letters

Cross Functional Collaboration

• Working with Quality Assurance, R&D, Clinical, Pharmacovigilance, and Medical Writing teams
• Supporting regulatory audits, inspections, and internal compliance activities

Required Qualifications

Educational Qualification

Candidates should have one of the following degrees:

• B.Pharm
• M.Pharm
• MSc in Life Sciences
• Or equivalent qualification in a related discipline

Professional Experience

• 3–6 years of experience in Regulatory Affairs or Regulatory Operations
• Experience in global regulatory submissions and eCTD publishing
• Exposure to regulated markets such as the US, EU, and UK is preferred

Salary and Benefits

The expected salary for this role typically ranges between ₹6 LPA to ₹10 LPA depending on experience, regulatory expertise, and industry background.

Additional benefits may include:

• Professional growth in global regulatory submissions
• Exposure to international regulatory authorities
• Opportunity to work with cross-functional pharma teams
• Stable full-time employment in the regulatory affairs domain

How to Apply

Interested and eligible candidates who meet the above requirements can apply by sending their updated resume via email.

Application Email

careers@medifodil.com

Candidates who are immediate joiners may be given preference during the selection process.