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10.0 - 14.0 years
0 Lacs
maharashtra
On-site
As a Deputy Manager Regulatory Affairs at PolyPeptide Group, you will play a crucial role in bridging operational execution with strategic oversight, ensuring compliance with global regulatory requirements and contributing to the success of the company. **Key Responsibilities:** - **Drug Master File (DMF) Management** - Prepare, review, and submit DMFs in compliance with US (FDA), EU (ASMF and CEP), Canada, China, Korea, Brazil, and other emerging market regulations. - Maintain and update DMFs throughout their lifecycle, including change filings and regulatory correspondence. - **Regulatory Strategy & Compliance** - Develop and implement regulatory strategies for generic synthetic, semi-synt...
Posted 6 days ago
3.0 - 7.0 years
0 Lacs
pune, maharashtra
On-site
You have hands-on experience working with the US, Canada, and European Market regions in regulatory publishing and submissions. Your expertise includes managing dossiers, using Lorenz, and working with Docubridge. As a Submission Publisher, you will be responsible for regulatory submissions related to the pharmaceutical industry. This is a full-time, permanent role in the ITES/BPO/KPO sector, specifically within the functional area of pharmaceuticals. You should be well-versed in handling dossiers, using Lorenz software, and working with Docubridge. The job code for this position is GO/JC/20989/2025. Your recruiter for this role is HariharanA.,
Posted 1 month ago
2.0 - 4.0 years
0 Lacs
Bengaluru, Karnataka, India
On-site
At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a to Submissions Senior Publisher to join our A-team. The Submissions Senior Publisher are responsible for preparation, compilation, and publication of electronic common technical documents (eCTD) and other regulatory submissions for investigational, new, and marketed drugs and devices. The Submissions Sr. Publisher has an increasing level of responsibility and is highly knowledgeable and experienced with complex types of submissions across different regulatory regi...
Posted 3 months ago
3.0 - 9.0 years
3 - 8 Lacs
Hyderabad, Telangana, India
On-site
This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation, and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management and Regulatory submissions. Roles & Responsibilities: Lead/support various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans. Participation in information system and software update projects as well as ongoing system validations. Serve as point of contact...
Posted 4 months ago
5.0 - 10.0 years
10 - 15 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi We are Hiring for the job role of Medical Writer Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound,...
Posted 4 months ago
6.0 - 11.0 years
10 - 15 Lacs
Pune, Bengaluru, Mumbai (All Areas)
Work from Office
Hi We are Hiring for the job role of Medical Writer Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound,...
Posted 4 months ago
4.0 - 9.0 years
10 - 15 Lacs
Mumbai Suburban, Pune, Mumbai (All Areas)
Work from Office
Hi, We are hiring for Leading ITES Company for Medical Writer Profile. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is sc...
Posted 4 months ago
4.0 - 9.0 years
10 - 15 Lacs
Mumbai, Pune, Mumbai (All Areas)
Work from Office
Hi Hiring for the leading ITES Company for Regulatory Medical Writer Profile. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the informatio...
Posted 4 months ago
1.0 - 6.0 years
10 - 15 Lacs
Bangalore Rural, Bengaluru
Work from Office
Hi, We are hiring for the Leading ITES Company for Medical Writing Role. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is ...
Posted 4 months ago
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