Sr Regulatory Consultant (Biologics/Biosimilars) Syneos Health

8.0 - 12.0 years

0 Lacs

pune, maharashtra

On-site

As a Senior Regulatory Consultant specializing in Biologics/Biosimilars at Syneos Health, you will play a crucial role in authoring and reviewing CMC sections of regulatory submissions for various applications such as INDs, IMPDs, CTAs, BLAs, and MAAs. Your responsibilities will include developing and ensuring the completeness of CMC sections within IND and IMPD applications while adhering to regulatory guidance from FDA, EMA, and ICH. Your expertise in analytical method development, validation, comparability, biosimilarity assessments, upstream and downstream process development will be essential. Furthermore, you will provide peer review and mentorship to junior writers or team members to ...

Posted 1 month ago

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Accounts AP, GL Era It Solution

6.0 - 10.0 years

8 - 12 Lacs

Gurugram

Work from Office

SAP FI exposure, Accounts Payable, GL accounting, INDS FY Audit closure, Provisions schedule & notes to accounts preparation, Fixed Assets accounting (basic), Payroll Accounting (basic), Big4 exposure - audit, manufacturing unit working, english

Posted 3 months ago

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Preclinical Sciences and Innovation (Pharmacology and Toxicolog) Lead Ocugen

5.0 - 7.0 years

8 - 15 Lacs

Hyderabad

Work from Office

Job Purpose Responsible for the design and oversight of safety pharmacology, exploration, and GLP-compliant toxicology studies. Manage multiple projects efficiently across various stages of discovery, preclinical, and clinical development. Contribute to the preparation and review of regulatory submissions and engage with regulatory authorities and cross-functional asset teams This position is located in Hyderabad, Telangana, India. Duties And Responsibilities : Preclinical Pharmacology Design, supervise, and interpret in vivo efficacy studies using a range of disease models. Provide scientific and technical oversight for preclinical pharmacology programs. Prepare study proposals, budgets, an...

Posted 4 months ago

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