US Regulatory TA Strategy Lead the development and execution of US regulatory strategy in conjunction with Global Regulatory Lead (GRL), Global Regulatory Team and Global project teams. Partner with the GRL to understand the competitive landscape, e.g., views of US HAs, regulatory precedents, labeling differences and TA specific issues. Utilize US regulatory expertise and

A collective energy and ambition. A place where you can make a real difference. We're a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and owner

The Global Clinical Regulatory Lead (GCRL) will assist Global Regulatory Leader (GRL) in the preparation and execution of global regulatory strategy for the assigned projects. Essential tasks may include background research on therapeutic knowledge, competitive landscape, and relevant regulatory guidance, and preparation of regulatory documents. The GCRL plays a key role

Duties WHAT IS THE LARGE BUSINESS AND INTERNATIONAL (LBI) DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas Large Business and International Director Northeastern Compliance Practice Area (NECPA) The following are the duties of this position at the full working level. If this vacancy includes more than

Partners with PV system stakeholders in R&D, Tech Ops and Commercial to monitor trends in regulatory inspection activities to proactively identify potential areas of risk, and develop proposals to mitigate against such risks. Collaborates with local site teams (e.g., IT, Facilities, R&D, Administrative Support, etc.) to ensure logistical support during inspections and aud

Lead Chatham's US Regulatory and Documentation practice, a unified team supporting all of our client sectors in navigating applicable regulations Collaborate with the International Regulatory and Documentation practice lead to ensure an appropriate degree of alignment in processes, priorities, and talent development Partner effectively with stakeholders outside of direct

DOT is seeking a dynamic City Planner to implement the future of outdoor dining in New York City as a member of the Open Restaurants team. NYC launched the groundbreaking Open Restaurant Program during the height of the COVID 19 emergency to expand outdoor dining options and help restaurants rebound in difficult economic times. The City is now working to turn the emergenc

Kyowa Kirin is a fast growing global specialty pharmaceutical company that applies state of the art biotechnologies to discover and deliver novel medicines in four disease areas bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments c

What success looks like in this role In this role you will Assist and handle public inquiries on civil registry documents such as birth certificates, marriage contracts and other important documents. Performs administrative tasks for frontline or backend operations which may include responding to customer inquiries and data encoding Operate a data entry terminal or comput

A collective energy and ambition. A place where you can make a real difference. We're a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and owner

Grow the planning practice in the Northeast/New York metro region and mentor staff. Lead business development activities, including developing and networking with clients, preparing planning strategies for proposals and contracts, and supporting regional market leaders in the real estate, institutional, state and local government, transportation, and energy markets. Devel

What success looks like in this role In this role you will Assist and handle public inquiries on civil registry documents such as birth certificates, marriage contracts and other important documents. Performs administrative tasks for frontline or backend operations which may include responding to customer inquiries and data encoding Operate a data entry terminal or comput

As the Director of Regulatory Affairs, you will lead a talented team and drive regulatory strategies for our groundbreaking products, focusing on New Drug Applications (NDAs) and Biologic License Applications (BLAs). You will spearhead the preparation and submission of regulatory documents, ensuring compliance with stringent FDA regulations and facilitating productive eng

Duties WHAT IS THE APPEALS DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas Independent Office of Appeals Specialized Exam Programs & Referrals/Area 10/Team 2 The following are the duties of this position at the full working level. Conducts Appeals conferences for the settlement of the largest and most

The GRC Specialist is responsible for assessing, managing, and mitigating risks associated with third party vendors and service providers. Implement security best practices, policies, and controls through a repeatable process. This role involves conducting thorough security evaluations of potential and existing vendors, conducting regular security awareness trainings, and