Senior Specialist Case Processing PharmaLex

5.0 - 9.0 years

0 Lacs

noida, uttar pradesh

On-site

As a member of the team at Cencora, you will play a crucial role in creating healthier futures for people and animals everywhere. Your responsibilities will include: - Performing triage and review for initial validity assessment of cases, such as spontaneous, health authority, Clinical Trial, and literature cases. - Data entry into the PV database. - Conducting initial ICSR assessment, when applicable. - Evaluating the need for expedited reporting to Health Authorities or partners of a client, including reporting timelines. - Preparing standard reporting forms like CIOMS I/MedWatch Forms and XML files. - Sending follow-up requests and submitting ICSRs to Health Authorities and partners of a ...

Posted 17 hours ago

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Regulatory Affairs Lead, Project Manager ArtiXio

5.0 - 9.0 years

0 Lacs

hyderabad, telangana

On-site

You are being sought after to take on the role of Regulatory Affairs Lead/ Project Manager, joining a dynamic team that values passionate regulatory professionals. Your main responsibilities will include managing regulatory projects for Pharmaceuticals, Biologics, Medical Devices, and other products in Global Markets. You will be expected to plan and prepare regulatory project plans/submission strategies, lead regulatory submissions, manage interactions with Health Authorities across multiple regions, and provide clear guidance to cross-functional teams by identifying regulatory gaps and assessing risks. Additionally, you will work closely with Regional Regulatory Experts, act as the primary...

Posted 1 day ago

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Assistant Manager - Regulatory Affairs Datwyler IT Services India LLP

3.0 - 7.0 years

3 - 8 Lacs

khandala, pune

Work from Office

Role & responsibilities Responsible to assess customers requests for Letters of Authorization (LOA) to reference Drug Master Files (DMFs) Issue LOAs for US-FDA, Health Canada and NMPA China. Maintain LOA data base, prepare analysis and share with the sales teams as required Prepare weekly data packages for DMFs & support RA Manager for the annual reports of all DMFs Responsible for the availability of annual washing validation reports of all healthcare sites, review reports and transform into submissions formats. Arrange samples and testing data required for submission Support RA Manager in preparation of dossiers and preparing response to the Health Authorities Manage timely notarization an...

Posted 1 month ago

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Expert Regulatory Writer Novartis

6.0 - 10.0 years

0 Lacs

maharashtra

On-site

As a Medical Writer at Novartis Healthcare Private Limited, you will be responsible for writing, reviewing, and managing the production of high-quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. Your role will also involve providing authoritative documentation-related consultancy to other line functions and coaching, mentoring, and training less experienced writers. In this position, you will author, review, and independently manage complex Clinical Study Reports (CSR), Risk Management Plans (RMP), and other documents for health authorities. You will lead writing teams for complex submissions, contribute to key messaging a...

Posted 2 months ago

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Regulatory Executive Synnat Pharma

5.0 - 9.0 years

5 - 10 Lacs

Visakhapatnam

Work from Office

We are looking for a meticulous Executive/Sr. Executive to spearhead regulatory submissions and review at Synnat Pharma Private Limited. In this pivotal role, you will be instrumental in ensuring our API manufacturing processes adhere to global pharmaceutical regulations. Your expertise will be essential in compiling, reviewing, and submitting comprehensive regulatory documentation to various health authorities, including the US FDA, EMA, and CDSCO. You will manage regulatory inspections, handle queries, and lead the preparation of DMF filings. The ideal candidate will possess a deep understanding of regulatory guidelines, ICH guidelines, and relevant pharmacopeias (USP, EP, BP), coupled wit...

Posted 3 months ago

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