Sr Regulatory Associate (CMC) Syneos Health

4.0 - 8.0 years

0 Lacs

pune, maharashtra

On-site

As a Senior Regulatory Associate (CMC) at Syneos Health, you will play a crucial role in ensuring compliance with regulatory guidelines and requirements. Your responsibilities will include: - Having a practical understanding of ICH guidelines, GMP requirements, and regional regulatory frameworks such as FDA and EMA. - Mandatory post-approval variation experience for the EU market and preferred pre-approval MAA dossier experience for ROW. - Strong expertise in preparing, compiling, reviewing, and submitting high-quality CMC dossiers for variations, renewals, annual reports, and RTQs. - Supporting change control assessment and impact assessments for global markets. - Executing day-to-day tasks...

Posted 1 month ago

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Manager-Regulatory & Business Continuity - US Market SUN PHARMA

5.0 - 9.0 years

0 Lacs

haryana

On-site

As a Regulatory Submission Specialist, your role involves handling the regulatory submission of new products, variations, and responses to queries for the US and OAM regions. Your primary responsibility is to prepare quality dossiers to ensure timely approvals for life cycle management. Key Responsibilities: - Review and prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. - Review various documents such as Development reports, scale-up reports, specifications, stability protocols, and analytical validations before initiating Exhibit batches. - Prepare responses to deficiencies to facilitate the approval of products filed with regulatory agencies. - Manage the ...

Posted 2 months ago

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Sr Regulatory Associate (CMC) Syneos Health

4.0 - 8.0 years

0 Lacs

pune, maharashtra

On-site

As a Senior Regulatory Associate (CMC) at Syneos Health, you will play a crucial role in ensuring regulatory compliance by leveraging your practical understanding of ICH guidelines, GMP requirements, and regional regulatory frameworks such as FDA and EMA. Your responsibilities will include preparing, compiling, reviewing, and submitting high-quality CMC dossiers for variations, renewals, annual reports, and RTQs. In this dynamic role, you will be expected to support change control assessment and impact assessments for global markets, as well as execute day-to-day tasks according to client processes and SOPs to build high-quality global CMC dossiers. Additionally, you will be involved in trai...

Posted 3 months ago

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