Regulatory Specialist
MSN LaboratoriesHyderabad, Telangana, India1 day 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 • Hyderabad, Telangana, India
Related jobs
- Promoted
Regulatory Affairs Specialist Oligonucleotides
Dr. Reddy's LaboratoriesHyderabad, Telangana, India We are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for thes...Show moreLast updated: 2 days ago
- Promoted
International Regulatory Liaison
MSN LaboratoriesHyderabad, Republic Of India, IN We are seeking a highly organized and detail-oriented.Regulatory Project Coordinator / Manager.Head Office (HO) and our Emerging Market country teams.
This critical role ensures the seamless and timel...Show moreLast updated: 1 day ago
- Promoted
Regulatory Affairs Coordinator
MSN LaboratoriesHyderabad, Republic Of India, IN We are seeking a highly organized and detail-oriented.Regulatory Project Coordinator / Manager.Head Office (HO) and our Emerging Market country teams.
This critical role ensures the seamless and timel...Show moreLast updated: 1 day ago
- Promoted
Senior Associate, Regulatory Affairs
ConfidentialHyderabad / Secunderabad, Telangana, India Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients.
As an industry leader in providing uniq...Show moreLast updated: 4 days ago
- Promoted
- New!
▷ Apply Now : Regulatory Specialist
MSN LaboratoriesHyderabad, Telangana, India 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.Th...Show moreLast updated: less than 1 hour ago
- Promoted
Tax and Regulatory Support Specialist
V Nagarajan & Co.Hyderabad, Republic Of India, IN Chartered Accountant firm based in Hyderabad, offering over 40 years of expertise in financial clarity, compliance, and strategic growth.
We cater to individuals, startups, NGOs, corporates, and int...Show moreLast updated: 4 days ago
- Promoted
CMC Regulatory Affairs Lead - Oligonucleotides
Dr. Reddy's LaboratoriesHyderabad, Republic Of India, IN We are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for thes...Show moreLast updated: 3 days ago
- Promoted
Asst Manager- Regulatory Affairs
Dr. Reddy's LaboratoriesHyderabad, Republic Of India, IN Job Summary We are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requireme...Show moreLast updated: 1 day ago
- Promoted
Senior Regulatory Affairs Trainer(Medical Devices)
Tek Supportsecunderabad, telangana, 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: 3 days ago
- Promoted
Oligonucleotide Regulatory Compliance Manager
Dr. Reddy's LaboratoriesHyderabad, Republic Of India, IN We are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for thes...Show moreLast updated: 3 days ago
- Promoted
- New!
▷ Immediate Start! Regulatory Affairs Specialist Oligonucleotides
Dr. Reddy's LaboratoriesHyderabad, Telangana, India Job Summary We are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirem...Show moreLast updated: less than 1 hour ago
- Promoted
Regulatory Affairs Specialist – (APAC & RoW)
vueverse.Hyderabad, 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: 3 days ago
- Promoted
Regulatory Affairs Specialist
ConfidentialHyderabad / Secunderabad, Telangana, India At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.
You'll lead with purpose, breaking down barriers to innovati...Show moreLast updated: 8 days ago
- Promoted
Regulatory Affairs Scientist - Oligonucleotide Products
Dr. Reddy's LaboratoriesHyderabad, Republic Of India, IN We are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for thes...Show moreLast updated: 3 days ago
- Promoted
Senior Regulatory Affairs Specialist
ConfidentialHyderabad / Secunderabad, Telangana, India Dyaz Innovate is a software company with its flagship product, DyazRIMS™, which supports the entire regulatory compliance process.
The company is committed to enhancing regulatory processes for clie...Show moreLast updated: 8 days ago
- Promoted
Regulatory Affairs Specialist –
vueverse.Secunderabad, 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: 3 days ago
- Promoted
Quality & Regulatory Specialist
ConfidentialHyderabad / Secunderabad, Telangana, India Recruitment, Website Design & Development, Digital Marketing, Study Abroad, and HR Consulting.With over a decade of trusted service, the company caters to a diverse clientele across India and globa...Show moreLast updated: 4 days ago
- Promoted
Client Specialist - Regulatory Inquiries
ConfidentialHyderabad / Secunderabad, Telangana, India Grade Level (for internal use) : .Customer Experience, a core capability within Market Intelligence, collaborates closely with the Revenue organization to deliver differentiated customer experience.T...Show moreLast updated: 4 days ago