Apply for Regulatory Affairs Specialist UK Legislation job at PLG India. Check eligibility, experience, remote work option, and apply details now.
Introduction
Looking to advance your career in global regulatory affairs? The Regulatory Affairs Specialist UK Legislation Job at PLG offers an excellent opportunity for professionals with experience in UK and EU regulations. This remote-friendly role allows candidates to work across the complete product lifecycle while ensuring compliance with international regulatory standards. If you have expertise in MHRA, EMA, and lifecycle management, this role can significantly enhance your career trajectory.
Job Overview
| Particulars | Details |
|---|---|
| Job Title | Regulatory Affairs Specialist – UK Legislation |
| Company Name | PLG |
| Location | India (Remote work possible) |
| Employment Type | Permanent |
| Department | Regulatory Affairs & Operations |
| Experience Required | 3–7 Years |
| Education | Bachelor’s in Life Sciences / Pharmacy (Master’s preferred) |
| Salary | As per company norms |
Company Overview
PLG is a growing life sciences organization focused on delivering regulatory, quality, and compliance solutions across global markets. The company works closely with pharmaceutical and healthcare clients to ensure adherence to evolving international regulations. With expertise in UK and EU legislation, PLG provides a dynamic environment for professionals seeking long-term growth in regulatory affairs and lifecycle management.
Job Location & Employment Type
- Location: India (Remote Work Available)
- Job Type: Permanent
- Work Flexibility: Remote / Work-from-home opportunity
This flexibility makes the role ideal for professionals seeking global exposure while working remotely from India.
Open Positions / Department Details
- Department: Regulatory Affairs & Operations
- Role Focus Areas:
- UK & EU regulatory compliance
- Product lifecycle management
- Submission and approval processes
Key Roles & Responsibilities
Submission and Approval Process
- Prepare and submit Manufacturing Licence Applications (MLA) for UK and EU markets
- Support Marketing Authorisation Applications (MAA) through national, MRP/DCP, and EU procedures
- Assist in technical and site transfer applications
- Compile and manage CTD/eCTD dossiers as per regulatory requirements
Lifecycle Maintenance
- Manage post-approval activities such as:
- Variations
- Renewals
- Line extensions
- MAH transfers
- Maintain product approvals across lifecycle stages
- Update product information including SmPC, PIL, labeling, and packaging
Regulatory Compliance
- Monitor UK and EU regulatory guidelines and updates
- Ensure compliance with Human Medicines Regulations and EU frameworks
- Support audit readiness and maintain regulatory documentation
Communication & Coordination
- Act as liaison with regulatory authorities including MHRA and EMA
- Provide regulatory support to internal teams such as Quality, PV, and Supply Chain
- Handle regulatory queries and authority communications
Software & Data Management
- Use systems like:
- Microsoft Office
- Veeva Vault / EDMS
- LorenZ
- Trackwise
- PromoMats
- Manage regulatory data and submission tracking efficiently
Eligibility Criteria
Education
- Bachelor’s degree in:
- Life Sciences
- Pharmacy
- Related field
- Master’s degree preferred
Experience
- 3–7 years in Regulatory Affairs
- Experience with UK and EU regulatory frameworks
- Hands-on experience in lifecycle management and submissions
Skills Required
- Strong understanding of MHRA and EMA regulations
- Experience in CTD/eCTD submissions
- Knowledge of labeling, artwork review, and product lifecycle updates
- Proficiency in regulatory software systems
- Excellent communication and coordination skills
- Ability to manage multiple projects effectively
- Fluency in English (additional EU languages are a plus)
Salary & Benefits
- Salary: As per company norms
- Remote working flexibility
- Exposure to UK and EU regulatory markets
- Opportunity to work on global submissions
- Professional growth in lifecycle management
- Collaborative and international work environment
Selection Process
The recruitment process may include:
- Initial application screening
- Technical interview (Regulatory Affairs focus)
- Final HR discussion
Candidates with strong UK/EU regulatory exposure will be prioritized.
How to Apply
Interested candidates should:
- Apply through the official job listing platform
(No email or walk-in details provided in the job description)
Important Dates
- Not specified (Apply as early as possible)
Why Apply for This Job?
The Regulatory Affairs Specialist UK Legislation Job at PLG offers a unique chance to work on international regulatory frameworks while staying in India. With remote flexibility and exposure to MHRA and EMA processes, this role is ideal for professionals aiming to build expertise in global pharmaceutical regulations.
Additionally, working across the full product lifecycle—from development to post-market compliance—provides comprehensive industry experience. This makes the position highly valuable for long-term career advancement in regulatory affairs.
FAQs
1. What is the main responsibility in this role?
The role focuses on managing regulatory submissions and lifecycle activities for UK and EU markets.
2. Is this a remote job?
Yes, remote work is possible, making it flexible for candidates across India.
3. What experience is required?
Candidates should have 3–7 years of experience in regulatory affairs with exposure to UK/EU regulations.
4. What qualifications are needed?
A Bachelor’s degree in Life Sciences, Pharmacy, or a related field is required.
5. Is knowledge of regulatory software necessary?
Yes, experience with tools like Veeva Vault, LorenZ, or similar systems is preferred.
Conclusion
The Regulatory Affairs Specialist UK Legislation Job at PLG is a strong opportunity for experienced professionals seeking global exposure in regulatory affairs. With remote flexibility, international project involvement, and career growth potential, this role is worth considering for ambitious candidates in the life sciences sector.
Disclaimer
IndiaPharmaJobs.in is an independent job information platform. We do not provide jobs or recruitment and are not affiliated with any company.
