3.0 - 7.0 years

0 Lacs

maharashtra

On-site

As the Regulatory Operations Specialist for the assigned specialty programs (NCE/BLA), your primary role will involve handling various regulatory operations activities. This will include CTA applications in EU, LATAM, USA, Canada, and ROW, CTIS management, submission management, eCTD publishing of all modules, and document management. It is crucial for you to have a thorough understanding of current Global Regulatory filing requirements and eCTD/CTIS structure. Your responsibilities will also include collaborating with Strategists (Leads) and coordinators to develop submission strategies and timelines. You will be responsible for preparing Regulatory Management Plans and Submission content p...

Posted 6 days ago

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Sr. Regulatory Publishing Specialist Makro Group

7.0 - 10.0 years

5 - 7 Lacs

hyderabad, madhapur, telangana

Work from Office

Job Title: Senior Regulatory Publishing Specialist Responsibilities:Technical Document Preparation: Lead the preparation, review, and submission of Technical documents/Dossiers (CTD/ACTD) for both Regulatory and Non-Regulatory Markets.eCTD Publishing: Proficiently handle the electronic regulatory submissions (eCTD), ensuring accuracy and compliance with regulatory standards. Submission Build Activities: Execute submission build activities, including creating inter-document links, conducting quality checks, validating compiled submissions, and ensuring timely dispatch.Collaboration with RA - Ops Team: Coordinate and engage with the Regulatory Affairs Operations team to facilitate on-time subm...

Posted 1 month ago

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Regulatory Specialist- CTA SUN PHARMA

3.0 - 7.0 years

0 Lacs

maharashtra

On-site

Candidate shall be responsible for assuming the role for the assigned specialty programs (NCE/BLA) and be accountable for regulatory operations activities. This includes, but is not limited to, CTA applications in EU, LATAM, USA, Canada, ROW, CTIS management, submission management, eCTD publishing of all modules, document management, etc. It is essential to have a comprehensive understanding and stay updated with current Global Regulatory filing requirements and eCTD/CTIS structure. You will collaborate with Strategists (Leads) and coordinators for submission strategy and timelines. Moreover, you will be required to prepare Regulatory Management Plan and Submission content plan for CT. The r...

Posted 2 months ago

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Sr. Regulatory Publishing Specialist Makro Group

7.0 - 10.0 years

5 - 7 Lacs

Hyderabad, Madhapur, Telangana

Work from Office

Posted 5 months ago

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Sr. Regulatory Publishing Specialist Makro Group

7 - 10 years

3 - 7 Lacs

Hyderabad, Madhapur

Work from Office

Job Title: Senior Regulatory Publishing Specialist Responsibilities: Technical Document Preparation: Lead the preparation, review, and submission of Technical documents/Dossiers (CTD/ACTD) for both Regulatory and Non-Regulatory Markets. eCTD Publishing: Proficiently handle the electronic regulatory submissions (eCTD), ensuring accuracy and compliance with regulatory standards. Submission Build Activities: Execute submission build activities, including creating inter-document links, conducting quality checks, validating compiled submissions, and ensuring timely dispatch. Collaboration with RA - Ops Team: Coordinate and engage with the Regulatory Affairs Operations team to facilitate on-time s...

Posted 5 months ago

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