Regulatory Specialist
MSN Laboratoriesraipur, chattisgarh, in11 hours ago
Job descriptionHO & Country Team Liaison : Serve as the primary liaison between the HO functional teams (Legal, SCM, IT, IP, Portfolio, R&D) and country regulatory teams to facilitate support and resolve queries efficiently. Supply Chain & Sample Coordination : Coordinate with Plant QC / QA to arrange Finished Product (FP) samples and Analytical Pre-Requisites for dossier submissions. Prepare Proforma Invoices and necessary declarations for sample shipments. IP & Portfolio Support : Coordinate with IP teams on patent-related aspects and with Portfolio teams on Product Evaluation Form (PEF) and Product Information File (PIF) requirements. R&D Collaboration : Coordinate with the R&D Project Management team on DPDM (Drug Product Development Management) and CDP (Clinical Development Plan) analysis. Communication : Conduct regular weekly and monthly calls with country and Indian RA teams to review progress, track dossier deliveries, and address regulatory issues. Due Diligence : Perform due diligence with QC labs and R&D teams to ensure compliance with country Ministry of Health (MOH) requirements, specifically ensuring working standard qualification and stability data maintenance. Market Support : Arrange back-end regulatory support for Business Development (BD) and Marketing teams, including securing supportive documents for tender participation in Emerging Markets. Logistics : Coordinate with logistics teams for the effective dispatch of all regulatory shipments. Planning : Actively participate in the New Dossier Planning process with Regulatory teams. Experience : Proven experience 5-6 years in Regulatory Affairs, Regulatory Operations, or Project Management within the Pharmaceutical industry, preferably with exposure to Emerging Markets. Regulatory Knowledge : Strong understanding of the documentation and submission process for international product registration / dossiers.
We are seeking a highly organized and detail-oriented Regulatory Project Coordinator / Manager to be the central point of contact between our Head Office (HO) and our Emerging Market country teams. This critical role ensures the seamless and timely delivery of all regulatory, technical, and administrative documentation required for product registration, dossier submissions, and market entry across various international territories.
Key Responsibilities :
I. Documentation & Legal Coordination
- Central Document Management : Coordinate the preparation, notarization, and Apostillization of essential legal and administrative documents, including Power of Attorneys (POAs), Letters of Authorization (LOAs), Good Manufacturing Practice (GMP) Certificates, Certificates of Pharmaceutical Product (CoPP), and Free Sale Certificates (FSC).
- Technical Documentation : Collaborate with the Regulatory Affairs (RA) team to compile, organize, and get technical documents (e.g., Qualitative & Quantitative (Q&Q) data) apostilled.
- Dispatch Management : Manage the timely preparation and dispatch of all hard-copy documents and samples to country-based regulatory teams.
II. Cross-Functional Project Management
III. Compliance, Due Diligence & Market Support
Create a job alert for this search
Regulatory Specialist • raipur, chattisgarh, in
Related jobs
![Sustainability Specialist [T500-21319]](https://cdn-logos.talent.com/v1/logo/image?feedcode=jobrapido-pms&company_name=ANSR)
- Promoted
- New!
Drug Safety Specialist
Tata Consultancy Servicesraipur, chattisgarh, in Argus / Case Processing / Drug Safety.Educational Qualification(s) Required –.Interested can share their CV on.Ability to understand and analyses the complex data and performs the activities includin...Show moreLast updated: 11 hours ago
- Promoted
Quality Systems Digital Transformation Specialist
Insight Globalraipur, chattisgarh, in Required Skills and Experience : .Proven experience with IT systems, coding, and data visualization tools.Familiarity with ARIS and Quickbase platforms is highly desirable.
Background in pharmaceutica...Show moreLast updated: 2 days ago
- Promoted
Healthcare Integration Specalist
Lenia Healthraipur, chattisgarh, in We’re a fast-growing healthcare data services company focused on secure, intelligent data exchange.By simplifying interoperability and automating workflows, we help healthcare organisations connect...Show moreLast updated: 16 days ago
- Promoted
Senior Regulatory Affairs Trainer(Medical Devices)
Tek Supportraipur, chattisgarh, in Job Title : Senior Trainer – Regulatory Affairs (Medical Devices).The ideal candidate will have hands-on experience in global regulatory submissions, product registration, quality system compliance,...Show moreLast updated: 2 days ago
- Promoted
Regulatory Affairs Specialist –
vueverse.Raipur, Republic Of India, IN Regulatory Submissions & Compliance.Author, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, ...Show moreLast updated: 1 day ago
- Promoted
Legal Researcher
Cognition Solutionsraipur, chattisgarh, in We are seeking a detail-oriented legal research and content specialist to join our team.The ideal candidate will have a strong background in researching complex laws and reviewing and writing conci...Show moreLast updated: 2 days ago
- Promoted
Certification Specialist (Informed) supporting LGC Group
UK India Business Councilraipur, India Informed is a market-leading global brand that builds trust in the sports nutrition sector.Its programmes set the benchmark to provide assurance sports nutrition products are safer, free from conta...Show moreLast updated: 12 days ago
- Promoted
Compliance and Contracts Specialist
Emeritusraipur, chattisgarh, in The Compliance & Contract Management Services Department is looking for a Compliance and Contracts Associate to assess, analyze, draft, review, negotiate and finalize contracts, compliance, invoice...Show moreLast updated: 2 days ago
- Promoted
Sr. Associate - Risk Advisory (HITRUST)
Cherry Bekaertraipur, chattisgarh, in Cherry Bekaert is a nationally recognized CPA firm with over 75 years of experience providing assurance, tax, and advisory services to our clients.
We are seeking a Senior Associate (HITRUST) to joi...Show moreLast updated: 17 days ago
- Promoted
- New!
HR Payroll Specialist (US)
Alp Consulting Ltd.raipur, chattisgarh, in Oversee the full cycle of multi-state payroll processing for salaried and hourly employees, ensuring accuracy, timeliness, and compliance with all applicable laws and regulations.Respond to payroll...Show moreLast updated: 11 hours ago
- Promoted
US Federal Contracts Support Analyst
Allwyn Corporationraipur, chattisgarh, in We are seeking a detail-oriented and motivated.US Federal Contracts Support Analyst.The role will involve working closely with U.
Federal Acquisition Regulation (FAR), Defense Federal Acquisition Re...Show moreLast updated: 30+ days ago
- Promoted
- New!
SAP RTR Tax Consultant (Brazil)
KATBOTZ®raipur, chattisgarh, in KATBOTZ LLC – Hiring SAP RTR Tax Consultant (Brazil).SAP RTR Tax Consultant – Brazil.This role focuses on leading SAP localization, tax configuration, and statutory compliance for Brazil, ensuring ...Show moreLast updated: 19 hours ago
- Promoted
Implementation Specialist
HighRadiusraipur, chattisgarh, in The Consultant will be responsible for owning and executing HighRadius Cloud product implementations for Fortune 2000 clients.
The Consultant is responsible for delivering the project with good qual...Show moreLast updated: 1 day ago
- Promoted
- New!
Litigation Specialist
DRRTraipur, chattisgarh, in We are seeking a Litigation Assistant who will provide support to the U.This role involves thorough research and verification of fund documents to confirm relationships between funds and their asso...Show moreLast updated: 11 hours ago
- Promoted
- New!
Sustainability Specialist [T500-21319]
ANSRraipur, chattisgarh, in ANSR is hiring for one of its clients.Visy is a family-owned Australian business and a global pioneer in sustainable packaging, recycling and logistics.
They operate across 150 sites globally, inclu...Show moreLast updated: 11 hours ago
- Promoted
- New!
Risk Management Specialist
LTIMindtreeraipur, chattisgarh, in LTIMindtree is a global technology consulting and digital solutions company that enables enterprises across industries to reimagine business models, accelerate innovation, and maximize growth by ha...Show moreLast updated: 11 hours ago
- Promoted
Strategic Consultant
EXLraipur, chattisgarh, in Join Our Team at EXL Health as a Senior Manager Healthcare Growth & Transformation.Are you passionate about transforming healthcare and driven by data? EXL Health is looking for a strategic thinker...Show moreLast updated: 22 days ago
- Promoted
Regulatory Affairs Specialist – (APAC & RoW)
vueverse.raipur, chattisgarh, in Regulatory Submissions & Compliance.Author, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, ...Show moreLast updated: 1 day ago