The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.

Communicate regularly and effectively in a cross-functional matrix with development, origination, fundamentals, finance, and political & regulatory affairs staff to translate regulatory and market issues into business impacts and opportunities to benefit the position of Pattern's new and core business interests in MISO and other priority markets.

Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.

Advanced life science degree or certification in Regulatory Affairs Sciences preferred. In this role, a typical day might include:The Regulatory Intelligence Manager performs proactive global monitoring and surveillance of changes in the regulatory landscape focused on the drug development lifecycle, i.e., preclinical through commercialization, as well as disseminate relevant regulatory intelligence information to Regeneron stakeholders.

Specific responsibilities include Quality Systems, FSMA, HACCP, GFSI/BRC, regulatory audits, food safety training, Regulatory Affairs, Plant Quality Assurance, Vendor Compliance, and Consumer Affairs.

Team with business unit Regulatory Affairs Specialists (RAS) to provide regulatory support for new product introduction (NPI) and marketed products under MDD and MDR Regulation. As Principal Regulatory Affairs Specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory bodies.

Invenergy is seeking a knowledgeable and proactive Senior Manager for Government Affairs to support our growing Public Affairs team. As a Senior Manager, California Government Affairs, this individual will focus on Invenergy’s California government affairs activities for all aspects of Invenergy’s growing business.

Job DescriptionInvenergy is seeking a knowledgeable and proactive Senior Manager for Government Affairs to support our growing Public Affairs team. This individual will work collaboratively with members of all departments within the company, including but not limited to Offshore Wind Development, Onshore Development, Origination, Transmission, Regulatory, and Environmental Compliance & Strategy.

Develop effective collaborations with research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations.

Knowledge and experience in clinical and CMC regulatory affairs for pre-licensed and clinical RA for licensed biologic product or vaccine. As a Director, Regulatory Affairs, Vaccines you will e nsure the development and execution of the appropriate Regulatory strategy(ies) for assigned US asset(s), across all stages of the product life cycle and consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP.

The Manager CMC Regulatory Affairs is responsible for CMC technical document review and writing, authoring and compiling the CMC sections for global regulatory filings by working closely with the cross-functional teams including CMC, Quality, Clinical and Regulatory Affairs to ensure all Regulatory CMC technical writing objectives are met for the innovative pipeline of early and late-stage T cell therapies.

Familiarity of the AML/CFT and sanctions regulatory environment for digital assets globally, including the BSA, OFAC and other sanctions regulations, and travel rule requirements. 12+ years of combined in-house/Biglaw experience, including leading regulatory coverage, preferably in fintech, banking, payments, capital markets or other institutional financial services.

Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.

Guides, directs and evaluates (1) Associate General Counsel, (3) Lease Administration Department (1) Senior Paralegals and, (2) Scientific & Regulatory Affairs Department. Provide guidance to Scientific and Regulatory Affairs on regulatory issues related to both product and procedures, including label safety, use of third party literature, and training documentation.

Position Overview QinetiQ U.S. seeks a junior Strategic Communications and Public Affairs Analyst responsible for managing an integrated marketing communications and public affairs portfolio on behalf of a federal law enforcement organization within the U.S. Department of Homeland Security.