Regulatory Affairs Specialist - Katalyst Healthcares & Life Sciences
Waltham, MA 02451
About the Job
Responsibilities:
- The Genomic Medicine Unit Chemistry Manufacturing & Control (CMC) development organization is responsible for all aspects of drug development, from molecule/pre-candidate to product approval.
- This encompasses drug substance (DS), drug product (DP) and analytical development, DS/DP clinical manufacturing, and support of global regulatory filings from IND submission to NDA approval.
- This role will build and maintain relationships with scientific staff, lab champions, functional heads, leadership, and support services to foster trust, facilitate solutions, on all assigned operations.
- They will facilitate efforts to overcome the obstacles and major roadblocks so scientists can succeed, while empowering them to function independently within the current operational workflows.
- They will review the scope of the various support services to identify gaps and solutions based on the requirements of the site.
- Facilitate coordination of disruptive activities required by workplace experience, real estate, or other initiatives coordinate to ensure science continuation.
- Manage office and lab basic consumables including issuing PO's, tracking and invoice approvals, receiving, handling, & stocking.
- BS required in Life Science discipline or engineering.
- Experience working with GXP integrated commissioning and qualification practices
- Experience working within a regulated environment.
- Experience with coordinating invasive operations from managing large capital projects/investments.
- Solid understanding of Health, Safety, Environmental and Legal requirements for operations.
- Clear operational experience in R&D and development laboratories.
- Excellent communication and technical writing skills.
- Demonstrated problem solving / trouble shooting skills.
- Direct experience working in regulated environments, i.e., cGMP, OSHA, EPA, etc
- Proficiency with Microsoft Office Suite, working knowledge of common intranet communication tools and business tools such as Concur, eBuy, EasyInvoice, and Workday.
- Ability to grow and gain entry to laboratory, manufacturing, and mechanical areas.
Source : Katalyst Healthcares & Life Sciences