Regulatory Affairs Specialist Job at MEDIFODIL Smart Pharma in Hyderabad for B.Pharm, M.Pharm, MSc candidates with global submission experience.
Introduction
The pharmaceutical regulatory sector continues to offer excellent career opportunities for professionals experienced in global regulatory submissions and compliance. MEDIFODIL Smart Pharma Solutions has announced a recruitment opportunity for the position of Regulatory Affairs Specialist at its Hyderabad location.
This role is suitable for experienced professionals who have worked with regulatory dossiers, eCTD publishing, and global regulatory submissions. Candidates with experience handling submissions for international regulatory authorities such as the US FDA and European agencies may find this position particularly valuable for advancing their careers in regulatory affairs. Regulatory Affairs Specialist Job at MEDIFODIL Smart Pharma
Company Overview
MEDIFODIL Smart Pharma Solutions is a pharmaceutical services company that supports regulatory operations, documentation, and compliance activities for pharmaceutical organizations. The company works closely with pharmaceutical manufacturers and research organizations to ensure that regulatory submissions meet international standards and regulatory authority requirements.
With expertise in regulatory documentation, submission management, and lifecycle regulatory support, MEDIFODIL helps pharmaceutical companies navigate complex regulatory environments across multiple global markets. The organization focuses on maintaining regulatory accuracy, compliance, and efficient submission processes for its clients. Regulatory Affairs Specialist Job at MEDIFODIL Smart Pharma
Job Location & Employment Type
Company: MEDIFODIL Smart Pharma Solutions
Position: Regulatory Affairs Specialist
Department: Regulatory Affairs
Job Location: Hyderabad, Telangana, India
Employment Type: Full-Time
Work Mode: On-site
Department & Role Overview
The Regulatory Affairs Specialist role focuses on supporting regulatory submission activities and maintaining compliance with global pharmaceutical regulatory requirements. Professionals in this position will work closely with cross-functional teams to prepare regulatory documentation and ensure that submissions are completed accurately and on schedule.
The role also involves working with regulatory dossiers and electronic submission formats used by international health authorities. Candidates with experience in regulatory publishing and lifecycle management activities will be well suited for this position.
Key Roles & Responsibilities
The selected candidate will support regulatory operations and ensure the proper preparation and submission of regulatory documentation. Regulatory Affairs Specialist Job at MEDIFODIL Smart Pharma
Major responsibilities include:
Regulatory Submission Activities
- Preparing, compiling, reviewing, and submitting regulatory dossiers in CTD, eCTD, and NeeS formats.
- Supporting submission processes for regulatory applications such as ANDA, NDA, DMF, IND, and MAA.
- Performing electronic submission publishing tasks including formatting, hyperlinking, bookmarking, validation, and document quality checks.
- Ensuring submissions are completed within defined timelines and meet regulatory standards.
Documentation Management
- Supporting preparation of Module 3 documentation, including manufacturing information, quality data, and stability studies.
- Assisting with Module 5 clinical documentation, including clinical study reports and supporting documents.
- Coordinating with internal teams such as CMC, clinical research, and medical writing for dossier compilation.
Regulatory Compliance
- Ensuring compliance with international regulatory guidelines including ICH, US FDA, EMA, and MHRA requirements.
- Monitoring regulatory updates and supporting implementation of updated regulatory guidelines.
- Maintaining submission records and regulatory documentation in internal systems.
Lifecycle Management Activities
- Supporting post-approval regulatory activities including variations, amendments, renewals, and supplements.
- Maintaining regulatory trackers, submission logs, and document management systems.
- Assisting with responses to regulatory authority questions, deficiency letters, and additional information requests.
Cross Functional Collaboration
- Working closely with teams from Quality Assurance, Research & Development, Clinical Operations, Pharmacovigilance, and Medical Writing.
- Supporting regulatory audits, internal compliance checks, and inspection readiness activities.
Regulatory Affairs Specialist Job at MEDIFODIL Smart Pharma
Eligibility Criteria
Educational Qualification
Candidates applying for this role should possess one of the following qualifications:
- B.Pharm (Bachelor of Pharmacy)
- M.Pharm (Master of Pharmacy)
- MSc in Life Sciences
- Or an equivalent qualification in a related scientific discipline.
Experience Required
- 3 to 6 years of experience in regulatory affairs or regulatory operations.
- Experience handling global regulatory submissions and eCTD publishing is required.
- Exposure to regulated markets such as United States, European Union, or United Kingdom is preferred.
Skills Required
Applicants should demonstrate both technical regulatory knowledge and strong coordination abilities.
Technical Skills
- Knowledge of CTD, eCTD, and NeeS regulatory submission formats
- Experience in regulatory dossier preparation and submission management
- Familiarity with global regulatory guidelines such as ICH, US FDA, EMA, and MHRA
- Understanding of regulatory lifecycle management activities
Soft Skills
- Strong analytical and documentation skills
- Attention to detail when preparing regulatory submissions
- Effective communication and teamwork abilities
- Ability to coordinate with multiple departments and stakeholders
Regulatory Affairs Specialist Job at MEDIFODIL Smart Pharma
Salary & Benefits
The expected salary for this role typically ranges between:
₹6,00,000 – ₹10,00,000 per year (depending on experience and expertise)
Additional benefits may include:
- Opportunities for professional growth in global regulatory affairs
- Exposure to international regulatory authorities and submission processes
- Collaboration with cross-functional pharmaceutical teams
- Stable full-time employment within the pharmaceutical regulatory domain
Selection Process
The hiring process may include several evaluation stages designed to assess the candidate’s regulatory expertise. Regulatory Affairs Specialist Job at MEDIFODIL Smart Pharma
Typical recruitment steps may include:
- Resume submission via email
- Initial screening by the HR or recruitment team
- Technical interview focusing on regulatory submissions and eCTD publishing
- Final interview with senior regulatory affairs professionals
- Offer confirmation and onboarding
Candidates with experience in international regulatory submissions may have an advantage during the selection process. Regulatory Affairs Specialist Job at MEDIFODIL Smart Pharma
How to Apply
Interested and eligible candidates can apply for this position by sending their updated resume via email.
Application Email:
careers@medifodil.com
Applicants should ensure that their resume highlights:
- Educational qualifications
- Regulatory affairs experience
- Experience in global regulatory submissions
- Knowledge of regulatory guidelines and publishing tools
Candidates who are available for immediate joining may receive preference during the selection process. Regulatory Affairs Specialist Job at MEDIFODIL Smart Pharma
Important Dates
Application Deadline: Not specified (early application recommended)
Why Apply for This Pharma Job?
The Regulatory Affairs Specialist position at MEDIFODIL Smart Pharma Solutions offers a strong opportunity for professionals looking to build expertise in global regulatory submissions. Regulatory affairs professionals play a crucial role in ensuring that pharmaceutical products meet regulatory requirements before entering international markets.
Working in this role provides valuable exposure to regulatory dossier preparation, global regulatory authorities, and pharmaceutical compliance processes. Professionals will also gain experience collaborating with various departments involved in drug development and regulatory operations.
For candidates interested in advancing their careers in pharmaceutical regulatory affairs, regulatory publishing, or global regulatory operations, this role provides an excellent platform for professional growth. Regulatory Affairs Specialist Job at MEDIFODIL Smart Pharma
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform created to share pharmaceutical, biotechnology, and healthcare job opportunities with job seekers.
We are not affiliated with MEDIFODIL Smart Pharma Solutions or any other company mentioned in this job post. Candidates should verify job details and apply only through official company communication channels. IndiaPharmaJobs.in does not charge any fee for job information or job applications. Regulatory Affairs Specialist Job at MEDIFODIL Smart Pharma
Final Call-to-Action
Professionals with experience in regulatory submissions, eCTD publishing, and global regulatory compliance are encouraged to apply for this opportunity. The Regulatory Affairs Specialist role at MEDIFODIL Smart Pharma Solutions offers exposure to international regulatory processes and collaboration with experienced pharmaceutical professionals.
If you meet the eligibility criteria and have the required regulatory expertise, submit your application soon to take the next step in your regulatory affairs career. Regulatory Affairs Specialist Job at MEDIFODIL Smart Pharma
