Senior Regulatory Affairs Specialist

Minimum 8 years’ experience in regulatory affairs or a related function in drug/biologic development.

Experience in managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format a plus.

Understanding of US, and Ex-US including international regulations and procedures in drug/biologics development; familiarity with ICH and regional regulatory requirements.

Reasonable accommodations may be made upon request to enable individuals to perform essential functions.

Responsible for submission planning, oversight of planning of IND related activities like Annual reports, Orphan drug reports, DSUR and other CTA activities for on-going study or study start-ups

Managing the planning, compilation, QC, and submission of Investigational Drug Applications (INDs), Biologics License Applications (BLAs), and their amendments.

Prepares routine IND and CTA amendments, for example, Annual Reports/DSURs, Investigator Packages, and SUSARs.

Independently, under limited supervision manages Vendors / CROs for planning and tracking of source documents to ensure high-quality IND, IND amendments, CTA, EU-CTR submissions are delivered in timely manner.

Support the implementation of regulatory strategy for assigned projects and programs for projects in all stages of development (IND through NDA/BLA approval and commercialization).

Represents Regulatory Affairs and provides regulatory expertise to cross-functional teams on specified projects and topics.