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 training and mentoring team members as needed based on project requirements. Your role will also entail liaising with cross-functional teams including Quality, Manufacturing, Analytical, etc., to gather necessary technical data and ensure regulatory consistency for global submissions. You should possess excellent written and verbal communication skills and be open to working in Cross-Cultural/Virtual teams, attending client meetings as required with relevant inputs. To qualify for this position, you should have a minimum of 4 years of experience in preparing, compiling, reviewing, and submitting high-quality CMC dossiers for variations, preferably with a Masters degree in pharmaceutical sciences or other life sciences. The ability to work independently, manage multiple priorities in a fast-paced consulting environment, and experience with RIMS/Veeva Vault for submission management are essential qualifications for this role. Syneos Health is committed to developing its employees through career development and progression, supportive line management, technical and therapeutic area training, peer recognition, and a total rewards program. Join us in our mission to accelerate the delivery of therapies and make a difference in the lives of patients worldwide. Find out more about Syneos Health and our impactful work at http://www.syneoshealth.com.,

Posted 1 week ago

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