Afreen S.

About Afreen S.

Over 10 years of Global Regulatory Affairs experience in the pharmaceutical…

Experience

1. Senior Lead Cmc Regulatory Afffair Specialist

   Moderna

   May 2023 — Present · Boston, MA, US

   Leads and drives global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects. Works on biologics (large molecule) and lead the team to provide familiarity on Vaccinations, and work with eCTD sections and Module 3. Works for preapproval, handling the IND, IMPD\'s, and CTA support. Upon approval of the IND and CTA, also handle the necessary change controls and amendments. Hit the groud with accurate submissions of IND, Commencial products, eCTD. Drafts the CMC sections of dossiers (initial IND/IMPD, ANDA,BLAs/MAAs and amendments), and ensure delivery of sections in a timely manner.• Provides expert input on CMC-related regulatory matters and potential impact on product development strategies.• Act as liaison with local health authority to apply, maintain, and update Manufacturing and Importation Authorization licenses to ensure compliance with all applicable regulatory requirements.• Represents Regulatory CMC on cross-functional project teams of both internal and external ones. Provide CMC regulatory expertise to cross-functional teams and support decision-making processes.• Act as regulatory SME via participation in RA regulatory compliance activities, e.g, participate in RA Oversees planning and execution of regulatory activities and submissions. Ensure development of robust regulatory strategies for the projects. Accountable for providing regulatory assessments of new business.Serve as primary author and reviewer of eCTD section and technical supporting documents for INDs, BLA’s, MAA’s, and other variant and supplemental regulatory submissions.enforcement letters and policy issues affecting the pharmaceutical/biologics industry. Serves as a mentor within the department. Ability to take on more complex projects and provide promotional regulatory training and coaching to team members.