Regulatory Manager (CMC, EU & Japan/China) Syneos Health

5.0 - 9.0 years

0 Lacs

haryana

On-site

Role Overview: As the Regulatory Manager (CMC, EU & Japan/China) at Syneos Health, you will play a crucial role in a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. The focus of the organization is on translating clinical, medical affairs, and commercial insights into tangible outcomes that address the realities of the modern market. In this role, you will have the opportunity to engage with the vast experience of Syneos Health, contributing to the collaboration on a significant percentage of Novel FDA Approved Drugs and EMA Authorized Products. Key Responsibilities: - Collaborate with a team of enthusiastic problem solvers to ass...

Posted 6 days ago

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Regulatory Manager (CMC, EU & Japan/China) Syneos Health

5.0 - 9.0 years

0 Lacs

haryana

On-site

As the Regulatory Manager (CMC, EU & Japan/China) at Syneos Health, you will be part of a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. Our focus is on translating clinical, medical affairs, and commercial insights into tangible outcomes that address the realities of the modern market. In our Clinical Development model, we prioritize placing the customer and the patient at the center of all our activities. We strive to simplify and streamline our processes, not only to enhance our interactions with clients but also to create a more conducive working environment for our employees. Whether you are engaged in a Functional Service P...

Posted 2 months ago

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Executive - Regulatory Affairs (API) Animal Health People Genix

3.0 - 8.0 years

5 - 7 Lacs

Bengaluru

Work from Office

Designation : Executive / Sr Executive Department : Regulatory Affairs (API Industry only ) Qualification :M.Sc in Chemistry. Experience: 3 to 6 years. CTC : Rs 5 lacs to 7 lacs. Key Skills: DMF, NDA / ANDA dossiers, Regulatory Affairs. Filing of new Drug Master Files (DMFs) / Dossiers to respective countries (US, Europe, EDQM, Japan ) by compiling the documents as per CTD requirements. To interact and coordinate with R&T and manufacturing sites for all regulatory submissions (New filing and Amendments) and customer requirements. Maintaining life cycle of products as per the respective region wise requirements. Submission of Applicant Part to customers as per the requirement. Candidates work...

Posted 3 months ago

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