Title: CMC Resource

Location: Onsite 3 days a week in Wilmington DE

Contract: 1 year

Products in Scope: Large Molecules, Small Molecules, Drug-Device Combination Products

Job Description: - Hands on expertise on regulatory submission strategies/roadmaps

- Expertise in providing the regulatory consultation/guidance

- Experience in handling Health Authority Interactions

- Preparation, Review and submission of Pre-IND/NDA/BLA meeting requests/packages - Preparation, review and submission of NDAs/BLAs/MAAs to global Health Authorities

- Handling of strategies, action plan, review of Health authority queries

- Experience in handling device related documents/data to ensure smooth submission of Drug-Device combination products

- Change Control assessment, strategy, guidance and preparation of post approval Supplements/ Variations

- Track, preparation, review and finalization of Renewal/Annual Reports packages

- Support in the market expansion to other countries

- Coordination and collaboration with all stake holders for collation of documents/data and successful completion of Dossiers and activities

- Participate the cross functional meetings and provide strategic guidance from CMC perspective

- Effective communications and collaboration skills