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

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

Job description Our purpose Opening up a world of opportunity explains why we exist. Here at HSBC we use our unique expertise, capabilities, breadth and perspectives to open up new kinds of opportunity for our more than 40 million customers. We're bringing together the people, ideas and capital that nurture progress and growth, helping to create a better world for our cus

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

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

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

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

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 Government Relations Associate serves as a member of the Museum's government and corporate relations team and is responsible for helping administer all facets of the government relations program at AMNH . This position will support the Vice President and Director of Government Relations. Responsibilities include, but are not limited to Administrative duties including

CMC Regulatory Strategy Partner with key stakeholders to develop and implement CMC regulatory strategies and plans for CMC projects. Develop solutions to regulatory or business problems where no clear precedence exists. Submissions for Development and Commercial Products Lead activities, including planning and reviewing US CMC sections of all regulatory submissions (i.e.

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

OF POSITION Independently authors, compiles, reviews, and schedules high quality regulatory submissions in adherence with standards that are fully compliant with FDA and ICH requirements within company timelines. Plans, coordinates and writes, clear, concise and accurate, responses to inquiries from FDA resulting from their review of the submissions. Submissions will inclu

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