This role will provide CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues to ensure a robust CMC regulatory strategy is developed and implemented to have on time submissions with the highest qua...
The Regulatory Affairs Specialist is responsible for regulatory activities to support new, modified and currently marketed medical devices in the company’s line of products. Regulatory Affairs Specialist II - Hannah. This includes the preparation of regulatory documentation for submission to regulat...
Minimum seven (7) years relevant work experience in regulatory relations/regulatory affairs, advising on prudential regulatory expectations, or in supervision at a federal banking agency. This position is responsible for providing consultation and guidance to senior leaders with respect to broad reg...
We are inviting professionals in high-growth industries who are thinking about their next move or looking for a new opportunity to join our expanding talent pool.The Marlee Talent Pool is a pilot project designed to:.Help job seekers get discovered by our partners based on their anticipated hiring n...
InCHOIR faculty are expert in study design, clinical coordination, regulatory approval and management, endpoint and event adjudication and Data Safety and Monitoring Board management. This position is responsible for translating regulatory knowledge relating to human research, including federal, sta...
As the new SVP of Regulatory Affairs, the successful candidate will lead the regulatory team in developing and implementing global regulatory strategies for the company's pipeline products as they expand beyond the USA. Develop global regulatory strategies to gain earliest possible regulatory approv...
The Senior Manager, Regulatory Affairs CMC, is responsible for developing and implementing global regulatory CMC strategies to secure and maintain market access for assigned product(s) in line with business objectives, and in coordination with key internal stakeholders. Primary responsibilities will...
Participate in the work of internal regulatory and compliance committees. Provide support to the wider Compliance & Ethics Program and other regulatory matters as required. ...
Provides high level strategic and operational regulatory direction and leadership on projects including, but not limited to, North America regulatory strategies, regulatory requirements for clinical studies and marketing approval in the NA markets, regulatory strategic development plans and risk ass...
Assists and supports the organization in complying with, as well as the ongoing preparation and monitoring of conformance to, the requirements of government regulations and/or regulatory agencies. May serve as point of contact for interactions with regulatory agencies for defined matters. Performs t...
Our client is looking to fill the role of CMC Regulatory Affairs Manager. Provide CMC regulatory strategy for investigational, new and marketing products (biologics and small molecule focus). Responsible for determination of regulatory and scientific/technical requirements for CMC and GMP related su...
Under the direction of the Senior Director or Executive Director, Global Regulatory Affairs provides strategic regulatory guidance developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activ...
Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling works closely with cross-functional partners to ensure timely and appropriate delivery of product ...
Represents Regulatory Affairs in institution meetings to provide regulatory guidance and recommendations for the organization’s programs and initiatives. The Regulatory Affairs Consultant supports the department’s efforts to ensure that the organization’s institutions operate in compliance with fede...
Prepare, coordinate and/or review all CMC and GMP related documents for submission to regulatory authorities to assure compliance with regulatory, company standards and scientific/technical requirements. Represents CMC RA in project team meetings and provides regulatory guidance and perspective to t...
Responsible to direct, coordinate and supervise activities of Regulatory Affairs staff. Reviews regulatory impact assessments drafted by RA staff for manufacturing and product changes for notification to regulatory agencies. Prepares regulatory plans and prepares needed regulatory submissions and as...
We’re currently seeking a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, Master/Senior Medical Review Officer who is looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel’s highly recognized Regulatory...
My client, a leading life sciences consulting firm, is searching for an experienced Regulatory Affairs Leader to serve as a strategic regulatory advisor to our clients in the fields of oncology and rare diseases. My client, a leading life sciences consulting firm, is searching for an experienced Reg...
We are seeking a dedicated Regulatory Affairs Officer with at least 2-3 years of experience in the medical device industry with a good understanding of medical device regulations with focus on EU and US to join our QARA team. Update and maintain technical documentation for medical devices in accorda...
Represent Regulatory Affairs on cross-functional project teams to resolve complex project issues by providing regulatory expertise and interpretation of regulations (including the navigation of "grey areas") to find the best product development and regulatory registration, approval, and compliance s...
Monitor GMP and regulatory compliance activities critical in a regulatory inspection. The Compliance Investigator investigates and writes exception documents for compliance to procedures and coordinates quality system programs and projects to ensure regulatory compliance. Provide support activity du...
Quality Associate Director of Regulatory Affairs and Regulatory Intelligence. Strong knowledge of Regulatory Affairs and years of experience in a Regulatory Intelligence position*. Promote regulatory compliance expertise, both externally and internally, by collaborating with colleagues and project t...
In this highly visible role, you will partner with a large, global pharmaceutical company and provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project teams, to ensure client's products are deve...
The Senior Director of CMC Regulatory Affairs for Biopharm products is an experienced and seasoned CMC Regulatory professional specializing in post-approval activities for Biopharm products. As part of the Global CMC Regulatory team, you define the CMC regulatory strategy in partnership with main st...