A thorough understanding of the complex Regulatory, Development and Medical Affairs requirements in oncology, as well as the emerging paradigm for cell & gene therapy. Precigen is advancing an exciting pipeline of novel cell and gene therapy products and to further our efforts we are seeking an Executive Director, Medical Affairs who will be instrumental in creating and building the global medical affairs function at Precigen for our first commercial launch.

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.

Lead and shape future clinical development strategy and clinical development plans, working closely with Development and Discovery Program Leads and counterparts in Regulatory, Clinical Development, Clinical Operations, Biostatistics, Clinical Pharmacology, Medical Affairs, Commercial, Non-clinical and Discovery Research for assigned studies.

The Montgomery County Department of Housing and Community Affairs (DHCA) is currently seeking to fill two Housing Code Inspector positions. Montgomery County Government is an equal opportunity employer, committed to workforce diversity.

Electrical System Design: Evaluate and design electrical, avionics and related systems for Hughes' broadband internet connectivity product, ensuring those designs meet performance, safety, and regulatory requirements.

You will drive interactions with key stakeholders across the business including but not limited to Safety Science, Clinical Pharmacology, Business Process Operations, Therapeutic areas, Patient Safety, Quality Assurance and Regulatory Affairs.

Assure effective development, implementation, and monitoring of budgets for assigned management units e.g., speech-language pathology, government affairs and public policy, special interest groups and international affairs.

The Senior Regulatory Operations Analyst is an advanced-level professional position responsible for a wide range of tasks in support of various regulatory compliance functions in Market Regulation and Transparency Services (MRTS), including those related to managing conflicts of interest-related compliance issues and inquiries and maintaining department-wide administrative policies and procedures.

He/she works closely with Director, Clinical Pharmacy, Clinical Operations, Clinical Research, CMC, Regulatory Affairs CMC, Supply Chain, QA, Finance and contracted CROs and external clinical supply vendors to forecast and manage clinical supply and ancillary supply needs and timelines for all clinical trials.

10 years of experience in wastewater treatment with at least 5 years in water quality and treatment (water quality analysis, treatment evaluations, process design, regulatory compliance assessments, etc.

This individual has strong skills in issue spotting, analyzing, understanding, and translating complex legislative, regulatory and policy issues to advise on pending legislation, regulations, changes in key government policy and other government affairs matters pertinent to Otsuka, and will fully appreciate the relationship between enterprise needs and state policy.

Background in pharmacology, toxicology, pathology, DMPK, drug development, and global regulatory requirements is required. Oversee, design, and report on nonclinical studies in accordance with international regulatory requirements.

Multidisciplinary grasp of public affairs, including government affairs, policy, advocacy, PR and issues management, and their associated synergies. Minimum 5 years of Hill or other commensurate government affairs experience.

Oversee the related expansion and optimization of global capabilities across manufacturing, quality, process development, analytical development, supply chain, and regulatory affairs. Collaborate closely with the Chief Operating Officer and their leadership team to effectively manage operations concerning the Novavax COVID vaccine, the company's proprietary MATRIX adjuvant product, and the global launch of new COVID variant vaccines, alongside innovative products like the Flu-COVID Combination vaccine (CIC.

Proven track record of developing strong partnerships, landscaping business opportunities and managing winning proposals to US government departments and agencies, such as Health and Human Services, Defense, Commerce, NIH, Veterans Affairs, etc.