Sr. Associate Medical Writing RA DDReg Pharma

4.0 - 8.0 years

0 Lacs

haryana

On-site

Role Overview: You will be responsible for drafting, reviewing, and ensuring the accuracy of scientific and regulatory documents in alignment with global standards. Your role will involve preparing complex CTD modules, conducting quality control of submissions, performing gap analysis, and providing support in responding to regulatory queries. Collaboration with cross-functional teams to support team development and process improvement will also be a part of your responsibilities. Key Responsibilities: - Author high-quality medical and regulatory documents following global guidelines, including Module 2 components like Quality Overall Summary, Nonclinical Overview, and Clinical Overview. - E...

Posted 19 hours ago

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Sr. Associate_ Medical Writing_ RA DDReg Pharma

4.0 - 8.0 years

0 Lacs

haryana

On-site

As an experienced Regulatory Affairs Medical Writer at DDReg Pharma Pvt Ltd, your role will involve drafting, reviewing, and ensuring the accuracy of scientific and regulatory documents in alignment with global standards. You will be responsible for preparing complex CTD modules, performing quality control of submissions, conducting gap analysis, and supporting in responding to regulatory queries. Collaboration with cross-functional teams to support team development and process improvement will be a key aspect of your responsibilities. Key Responsibilities: - Author high-quality medical and regulatory documents following global guidelines. - Prepare complex regulatory documents including Mod...

Posted 4 days ago

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Executive - Analytical Orion Pharma

0.0 years

0 Lacs

hyderabad, telangana, india

On-site

Job Description The role will have the following responsibilities: Responsible for planning stability studies, writing and/or review of stability protocols, reports, and preparation of technical documents in CTD format. Co-ordinate and follow up stability studies at contract research organizations (CROs)/ Chemical Quality Control lab of Orion (CQC). Co-ordinate and follow up validation and method transfer at CROs. Write/check/review analytical and pharmaceutical documents as per regulatory requirements (method and validation documents/ variations/ additional question responses) Evaluate/ review method validation protocols / reports / analytical methods prepared by CROs. Reviewing and comment...

Posted 1 week ago

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Regulatory Affairs Specialist - CMC (USFDA) vueverse.

7.0 - 11.0 years

0 Lacs

hyderabad, telangana

On-site

As a Regulatory Affairs Manager specializing in CMC, you will be responsible for leading and managing all CMC regulatory activities related to USFDA submissions, specifically focusing on ANDA preparation, review, and filing. Your role will involve overseeing the compilation and timely submission of Annual Reports, amendments, and responses to deficiencies. You will collaborate with cross-functional teams such as Quality Assurance, Production, and R&D to gather the necessary documentation and data required for regulatory submissions. A significant aspect of your responsibilities will include reviewing and ensuring compliance of Batch Manufacturing Records (BMR), process validation documents, ...

Posted 3 months ago

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