Sr Regulatory Associate (CMC)

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 according to client processes and SOPs to build high-quality global CMC dossiers. - Assisting in training and mentoring team members as per project requirements. - Liaising with cross-functional teams to gather technical data and ensure regulatory consistency for global submissions. - Timely sensitization and escalation within the team to maintain compliance and adherence to timelines. Additionally, you should: - Understand regulatory requirements for Marketing Authorization dossier applications for ROW markets. - Have optional experience in tracking/submission of regulatory/CMC commitments and updating databases. - Possess hands-on experience with RIMS/VEEVA vault. - Demonstrate excellent written and verbal communication skills. - Be open to working in Cross-Cultural/Virtual teams and attending client meetings as needed with relevant inputs. Qualifications required for this role: - Minimum 4 years of experience in preparing, compiling, reviewing, and submitting high-quality CMC dossiers for variations. - A Master's degree in pharmaceutical sciences (preferred) or other life sciences. - Ability to work independently, manage multiple priorities in a fast-paced consulting environment, and strong organizational skills. Experience with RIMS/VEEVA Vault for submission management, document lifecycle tracking, and regulatory compliance. Discover the impact you can make at Syneos Health, a global organization dedicated to accelerating customer success in the biopharmaceutical industry. With a track record of working on a significant number of FDA-approved drugs and EMA authorized products, you'll be part of a team that challenges the status quo in a highly competitive and ever-changing environment. For more information about Syneos Health, visit http://www.syneoshealth.com.,