Intelur Hiring Regulatory Affairs
- Company Overview
- Job Role & Responsibilities
- Key Responsibilities:
- Core Expertise Required:
- Eligibility / Qualifications
- Required Education:
- Experience:
- Key Skills:
- Location & Salary
- Job Location:
- Salary:
- Application Process
- Apply via Email:
- Website:
- Why This Role Matters in Pharma & Healthcare
- Frequently Asked Questions (FAQs)
- 1. Who can apply for this Regulatory Affairs position?
- 2. Is experience with US FDA and EMA mandatory?
- 3. What is the selection process?
- 4. Is this role suitable for freshers?
- 5. What type of work will I be doing daily?
- Summary
Intelur Pharma Science Pvt Ltd is actively hiring experienced Regulatory Affairs professionals for international markets, offering exciting career growth opportunities in a full-time role based in Bengaluru. This opportunity is ideal for candidates with 3 to 5 years of experience in regulatory submissions, dossier preparation, and global compliance across US FDA, EU EMA, ROW markets, and CDSCO guidelines. While this is not a fresher role, professionals looking to advance their careers in pharmaceutical regulatory affairs, clinical compliance, and global drug approval processes will find this position highly rewarding.
Company Overview
Intelur Pharma Science Pvt Ltd is an emerging pharmaceutical consulting and regulatory services company focused on delivering end-to-end solutions in drug development and global market approvals. With a strong emphasis on regulatory intelligence, dossier submission strategy, and compliance with international standards, the company supports pharmaceutical organizations in navigating complex regulatory frameworks.
The organization is known for its expertise in regulatory affairs consulting, helping clients achieve faster approvals in regulated and semi-regulated markets. By aligning with global standards such as US FDA, EMA, ICH, and CDSCO, Intelur Pharma ensures high-quality submissions and compliance-driven outcomes that directly contribute to patient safety and healthcare advancement.
Working here gives professionals exposure to high-value regulatory operations, global documentation systems, and strategic planning that plays a critical role in bringing life-saving medicines to market.
Job Role & Responsibilities
As a Regulatory Affairs Specialist for international markets, your role will involve handling complex regulatory documentation and submission strategies across multiple geographies. This position demands strong technical knowledge, attention to detail, and hands-on experience in global regulatory processes.
Key Responsibilities:
- Develop and execute regulatory strategies for product registration in US, EU, and ROW markets
- Prepare and review CTD/eCTD dossiers for submissions to regulatory authorities
- Manage end-to-end dossier lifecycle including compilation, submission, tracking, and approval
- Ensure compliance with US FDA, EMA, CDSCO, and ICH guidelines
- Coordinate with cross-functional teams including R&D, Quality Assurance, and Manufacturing
- Handle regulatory queries, deficiency responses, and variations
- Maintain up-to-date knowledge of changing global regulatory requirements
- Support client-facing regulatory consulting projects and provide strategic insights
- Participate in regulatory audits and ensure documentation readiness
Core Expertise Required:
- Strong understanding of global regulatory frameworks and submission pathways
- Hands-on experience with dossier preparation and electronic submissions
- Familiarity with regulatory publishing tools and documentation systems
- Ability to manage multiple projects and meet tight submission deadlines
Eligibility / Qualifications
Candidates must meet the following educational and professional criteria to be considered for this regulatory affairs role:
Required Education:
B.Pharm, M.Pharm, MSc (Pharmaceutical Sciences, Life Sciences, Chemistry, Regulatory Affairs, Clinical Research, Biotechnology)
Experience:
- 3 to 5 years of relevant experience in pharmaceutical regulatory affairs
- Proven experience handling international market submissions (US, EU, ROW)
Key Skills:
- In-depth knowledge of ICH guidelines (Q, S, E, M)
- Strong understanding of CTD/eCTD dossier formats
- Experience with regulatory strategy and submission planning
- Excellent communication skills for client interaction and regulatory coordination
- Analytical thinking and problem-solving ability in regulatory compliance scenarios
Location & Salary
Job Location:
Bengaluru, India
Salary:
Competitive salary package offered based on experience and expertise in regulatory affairs, dossier submissions, and global compliance exposure.
Professionals with strong experience in US FDA submissions, EMA approvals, and regulatory consulting can expect higher compensation aligned with industry standards.
Application Process
Interested candidates who meet the eligibility criteria can apply directly by sharing their updated CV along with a brief cover note highlighting their regulatory experience.
Apply via Email:
Website:
Ensure your resume clearly reflects your experience in regulatory submissions, CTD/eCTD documentation, and international compliance projects to improve your chances of shortlisting.
Why This Role Matters in Pharma & Healthcare
Regulatory Affairs is one of the most critical functions in the pharmaceutical and life sciences industry. Professionals in this domain ensure that medicines meet global safety, efficacy, and quality standards before reaching patients.
By working in this role, you contribute directly to the approval of life-saving drugs across international markets. Your expertise in regulatory documentation, compliance, and submission strategy plays a key role in accelerating drug development timelines and ensuring patient access to essential medicines.
This makes Regulatory Affairs one of the most stable, high-growth, and high-value career paths in the pharmaceutical industry.
Frequently Asked Questions (FAQs)
1. Who can apply for this Regulatory Affairs position?
Candidates with B.Pharm, M.Pharm, or MSc degrees and 3–5 years of experience in regulatory affairs, especially in international markets, are eligible.
2. Is experience with US FDA and EMA mandatory?
Yes, practical exposure to US FDA, EMA, or ROW market submissions is highly preferred for this role.
3. What is the selection process?
The selection process typically includes resume screening, technical interview, and final HR discussion based on regulatory expertise.
4. Is this role suitable for freshers?
No, this position requires prior experience in regulatory affairs and dossier submissions.
5. What type of work will I be doing daily?
You will handle regulatory documentation, dossier preparation, submission tracking, compliance activities, and coordination with global regulatory authorities.
Summary
| Company | Intelur Pharma Science Pvt Ltd |
|---|---|
| Vacancies | Regulatory Affairs Specialist |
| Required Education | B.Pharm, M.Pharm, MSc (Pharma, Chemistry, Life Sciences, Biotechnology, Regulatory Affairs) |
| Experience | 3–5 Years in Regulatory Affairs (US FDA, EMA, ROW, C |
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