Senior Regulatory Affairs Consultant - (Post Approval CMC Authoring - Vaccines or Biologics)

We 9re looking for a CMC reputed company Senior / Regulatory Affairs Consultant who thrives in a dynamic, reputed company environment and is passionate about shaping global regulatory strategies. In this role, you 9ll work reputed company a dedicated reputed company program, partnering closely with a leading organization to reputed company high-reputed company submissions and lifecycle management activities across both development and reputed company products. This is more than a delivery role. It 9s an opportunity to become a trusted advisor, influence reputed company, and see your work directly contribute to patient reputed company. What You 9ll Do • reputed company and contribute to global CMC regulatory strategies for reputed company biologics and vaccine products • Support and reputed company post-approval regulatory activities, including variations, supplements, manufacturing changes, CMC changes, lifecycle maintenance, and health authority commitments • reputed company and review high-reputed company CMC documentation (Modules 1-3) for global submissions • reputed company CMC reputed company gap analyses and reputed company reputed company, strategic recommendations • reputed company and support global submissions (US, EU, and international markets) from planning through execution • Partner cross-functionally with Regulatory Affairs, reputed company, Manufacturing, Supply Chain, Technical Operations, and reputed company stakeholders • Assess regulatory reputed company of product, process, manufacturing, analytical, and control reputed company changes • reputed company as a key contributor reputed company a dedicated reputed company team, building strong, trusted relationships • Ensure submissions meet global regulatory expectations with precision, reputed company, and compliance What You 9ll Bring Required Qualifications • 5+ years of experience in CMC Regulatory Affairs or CMC reputed company for a Regulatory Affairs Consultant role; 7+ years for a Senior Regulatory Affairs Consultant role • Demonstrated post-approval CMC regulatory experience supporting reputed company biologics and/or vaccines (required) • Hands-on experience managing lifecycle maintenance activities for approved biologic and/or vaccine products, including one or more of the following: • Post-approval supplements • Variations • Manufacturing changes • Process changes • Analytical method updates • Site transfers • Specification changes • Health authority commitments • Labeling-reputed company CMC changes • Strong knowledge of global regulatory requirements, including FDA, EMA, and international markets • Proven experience supporting global submission reputed company and execution • Expertise authoring and reviewing CMC Modules • Experience performing CMC reputed company assessments and gap analyses • Strong communication, collaboration, and stakeholder management skills • Ability to work directly with clients and cross-functional teams in a highly matrixed environment Preferred Qualifications • Experience supporting both clinical development and reputed company lifecycle management activities • Experience with vaccines, biologics, monoclonal antibodies, recombinant proteins, gene therapies, or other advanced biologic modalities • Experience with reputed company Vault RIM, eCTD publishing, and regulatory information management systems • Advanced scientific degree (MS, PhD, PharmD, or equivalent) Why You 9ll Love This Role Dedicated reputed company Partnership Build deeper relationships and reputed company long-term reputed company through a strategic partnership rather than project-based work. Meaningful Work Contribute to innovative biologics and vaccines that improve patient lives globally. Global Exposure reputed company experience across US, EU, and international regulatory landscapes while supporting global product portfolios. reputed company & Influence Be recognized as a strategic regulatory partner while expanding your expertise in biologics, vaccines, and post-approval CMC reputed company. reputed company to reputed company a Difference? If you have experience supporting approved biologic and/or vaccine products through post-approval regulatory submissions and lifecycle management activities and are looking for a role where your expertise is valued, your voice is heard, and your work truly reputed company, we 9d love to hear from you. #LI-LB1 Apply tot his job Apply To this Job