**Hybrid Role in Somerset, NJ**
Job opportunity with a top Biotech/Pharmaceutical company that is looking for a Sr. Consultant Regulatory Affairs to join their team on a 12-month contract with an opportunity for conversion or extension!
Qualifications:
- Bachelor or Master's Degree in a scientific area (Degree in Pharmacy/Regulatory Affairs is preferred)
- 2-3 years' experience in the pharmaceutical industry.
- Experience focused on generics.
Job Description/Skills:
- Independently manage the planning, authoring, review, compilation, organization, and preparation of Chemistry, Manufacturing, and Controls (CMC)/Technical data for high-quality registration submissions, such as ANDAs, INDs, NDAs Amendments, Supplements, and Annual Reports
- Prepare, develop, and define timelines for FDA responses to queries and ensure the issues are addressed in a complete and timely manner
- Provide CMC strategy and raise key issues throughout the lifecycle of products in a timely manner to project teams and management.
- Review ANDAs, supplements, and amendments and highlight any major gaps in the submission documents
- Creation and Maintenance of Drug product labeling including track of RLD labeling updates creation and drug listing activities.
- Preparation and submission of Labeling Supplements, Annual Reports, and other administrative FDA correspondences.
- Independently review, compile, and submit high-quality controlled correspondences and meeting requests
- Initiated, evaluated and approves change controls (as needed) in accordance with FDA and ICH guidelines
Benefits/Perks:
- 401k
- Health Insurance
Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?
