A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.

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.

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.

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.

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.

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.

What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated organizational leadership skills at both functional and enterprise levels.

We invested in new offices, sector teams and practice groups including investor engagement; shareholder activism; governance; regulatory and public affairs, including geopolitical; crisis; litigation; social issues including climate change and diversity, equity and inclusion; cybersecurity, data and privacy; employee engagement; digital communications; opinion research and analysis, and; creative services.

The Counsel position will be an integral part of the Regulatory, Operations, Government Affairs and Environmental team. The Counsel will assist the Deputy Chief Counsel and Principal Counsel on various transactional, operational and regulatory legal matters primarily for Disney Signature Experiences (with a focus on Disney Cruise Line) and also the Walt Disney World Resort.

Our work depends on Regulatory Affairs Manager joining our team to contribute to PKI and Identity Management policy development, technical liaison and advisor. Seize your opportunity to make a personal impact as a Regulatory Affairs Manager supporting a PKI Government High Value Asset Mission Essential Function program.

10 years of relevant experience with either government, prime government contractors, consulting firms and/or NGO organizations related to national security, defense, information warfare, influence, operations, foreign affairs, international development, and other relevant fields.

B.A. in International Relations, National Security, Foreign Affairs, Regional Studies, Political Science and/or related disciplines. Advanced degree in International Relations, National Security, Foreign Affairs, Regional Studies, Political Science and/or related disciplines.

Partner with the AVP, Public Policy and Regulatory Affairs in the development of pro-rental housing legislation. Job Type Full-timeDescriptionThe Assistant Vice President, Federal Legislative Affairs develops, coordinates and implements lobbying efforts on Capitol Hill overseeing a team of Directors of Federal Legislative Affairs.