Regulatory Affairs Specialist – UK & EU Legislation | Full-Time | India (Remote Work Possible)
Experience Required: 3–7 years
Job Description:
PLG is seeking a proactive and detail-oriented Regulatory Affairs Specialist to ensure UK and EU regulatory compliance across the product lifecycle. This role involves supporting product development, approvals, and post-market maintenance in alignment with MHRA and EMA requirements, while acting as a key regulatory liaison for cross-functional teams.
Key Responsibilities:
1. Submission and Approval Process
Prepare and submit Manufacturing Licence Applications (MLA) for new products and site transfers in the UK and EU.
Support Marketing Authorisation Applications (MAA) submissions via UK national, MRP/DCP, and EU procedures.
Assist with Technical and Site Transfer Applications related to manufacturing changes, product launches, and regulatory updates.
Compile and manage CTD/eCTD dossiers, ensuring adherence to MHRA and EMA standards.
2. Lifecycle Maintenance
Manage post-approval regulatory activities including Variations, Renewals, Line Extensions, and MAH Transfers.
Maintain approved Marketing Authorisations, ensuring timely and compliant submissions throughout the product lifecycle.
Handle updates to Product Information (SmPC, PIL), labelling, artwork, and packaging in line with regulatory approvals.
3. Regulatory Compliance
Monitor, interpret, and apply UK and EU legislation, guidelines, and regulatory intelligence updates.
Ensure compliance with UK Human Medicines Regulations and EU regulatory frameworks.
Support inspection and audit readiness by maintaining accurate and compliant regulatory documentation.
4. Communication & Collaboration
Serve as a primary contact with MHRA, EMA, and national competent authorities.
Provide regulatory guidance to cross-functional teams including Quality, Supply Chain, Pharmacovigilance, and Commercial.
Coordinate responses to regulatory authority inquiries and requests for information.
5. Software Utilisation & Data Management
Use regulatory and document management systems (e.g., Veeva Vault, LorenZ, Trackwise, PromoMats, Microsoft Office) for submission tracking, archiving, and reporting.
Analyse and manage regulatory data to support submissions, lifecycle activities, and compliance monitoring.
Qualifications & Experience:
Bachelor’s degree in Life Sciences, Pharmacy, or related field (Master’s degree preferred).
3–7 years of Regulatory Affairs experience, with UK and EU regulatory exposure.
Hands-on experience with MAA support, CTD/eCTD dossiers, product labelling, line extensions, and artwork review.
Strong understanding of MHRA and EMA procedures and post-approval requirements.
Proficiency with regulatory systems and databases (Veeva Vault, LorenZ, Trackwise, PromoMats, Microsoft Office).
Excellent English communication skills; additional EU languages are advantageous.
Strong organisational skills with the ability to manage multiple priorities in a dynamic environment.
Experience in coordination, project support, or promotional/non-promotional regulatory activities is a plus.
Location: India (Remote work flexibility available)
Why Join Us:
Contribute to global regulatory compliance and product lifecycle management in the life sciences sector.
Collaborate with multidisciplinary teams across regulatory, quality, and commercial functions.
Opportunities for professional growth, training, and exposure to UK and EU regulatory environments.
Flexible and supportive work environment promoting career development and work-life balance.
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