Regulatory Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory approval process for our clients. The Associate Principal Regulatory Writer (APRW) is a major contributor to document authorship for a variety of clinical documents across diff...
Be the recognized expert and attend and be a sought-out speaker at regulatory policy public conferences, regulatory/inter-market groups, and meetings of FINRA committees on areas of subject matter expertise. The Vice President & Associate General Counsel, Capital Markets directs, manages, and su...
The Associate Director, Regulatory Affairs will be responsible for supporting the development and implementation of global Chemistry, Manufacturing and Control (CMC) regulatory strategies and managing the preparation of supporting documents. Fore Biotherapeutics is seeking an experienced and highly ...
Key responsibilities are to build strong relationships with key stakeholders within Member Supervision's regulatory programs and other Regulatory Operations departments, as well as cross-functional partners enterprise-wide, including Finance, Technology, and People Solutions to support business stak...
Manage portfolio timelines in collaboration with Regulatory Operations and Regulatory Affairs staff to effectively enable a robust regulatory submissions calendar. Review clinical site regulatory documents to provide Regulatory approval to ship investigational product. Assist Project Team Regulatory...
Anticipate regulatory obstacles and emerging issues, including changing regulations, throughout the product lifecycle and develop solutions with other members of regulatory and related teams. Ability to follow scientific arguments, identify regulatory scientific data needs, and solve regulatory issu...
The Regulatory Strategy Lead works to coordinate interactions with FDA and other Health Authorities, to validate regulatory strategy, and to facilitate planning of regulatory agency meetings and interactions. The Regulatory Strategy Lead will also be responsible for recommending strategies for earli...
She/he utilizes in-depth knowledge of global regulatory submission requirements and works collaboratively within Regulatory Affairs and other cross-functional departments in providing guidance towards achieving department application filing objectives, identifying areas of concern that are impacting...
This includes assessing CMC changes during development and defining regulatory CMC requirements, demonstrating sound regulatory insight, ensuring a balanced approach to regulatory risk, utilizing regulatory intelligence, and incorporating knowledge of the changing regulatory environment. Reporting t...
RSM's AML/Regulatory Compliance group is currently seeking a strong resource to join our fast growing Risk Consulting practice at the Senior Associate level. This position will lead and deliver regulatory compliance internal audits, assessments, model validations and other services at client locatio...
As a Regulatory Compliance and Operational Risk Senior Associate, you will get the opportunity to grow and contribute to our clients' business needs by providing in-depth technical knowledge on emerging regulations and help organizations leverage efficiencies within the Risk Advisory Practice – all ...
The Regulatory Strategy Lead works to coordinate interactions with FDA and other Health Authorities, to validate regulatory strategy, and to facilitate planning of regulatory agency meetings and interactions. The Regulatory Strategy Lead will also be responsible for recommending strategies for earli...
We are looking for our next Senior Global Mobility and HR Compliance Specialist within our Americas Regional HR Shared Services. The Senior Global Mobility and HR Compliance Specialist will be responsible for managing the end to end international and domestic mobility and/or immigration processes fo...
Project Manager overseeing marketing and digital projects. In addition, the Project Manager will work with the client team to drive efficiencies/productivity across their creative spend, through partner negotiation, process streamlining and establishing technology pilots. Data and budget analysis/fi...
Liaises cross-functionally with partners in Commercial, Medical Affairs, Regulatory, Legal, Public Relations, and others to develop holistic strategies around communication initiatives, working within the regulatory framework and boundaries. Provides leadership within the Regulatory department, iden...
Establishes processes and measures to monitor conformance with Regulatory Affairs procedures and compliance with regulatory requirements. Interpret regulatory intelligence to assess the impact on Exelixis and advise Regulatory Affairs leadership accordingly. Establish process and measures to ensure ...
The responsibilities include providing US and global regulatory leadership and direction for gene therapy products, including developing long and short-term planning of regulatory projects that align with the company's business plan, and developing strategies to ensure effective achievement of regul...
Daily management of all phases of environmental projects:. ...
The Project Manager develops project specific health and safety plan in coordination with health and safety manager and communicates the plan with the project team, as well as monitors the plan. The Project Manager clearly communicates updates to the client, management, and project team, as well as ...
As a Regulatory Compliance and Operational Risk Senior Manager, you will get the opportunity to grow and contribute to our clients' business needs by providing in-depth technical knowledge on emerging regulations and help organizations leverage efficiencies within the Risk Advisory Practice - all wi...
The Specialistwill professionally and competently manage and support external regulatory inquiries with a focus on protecting the Chubb brand by:. Reports to a Regulatory Affairs Manager within the NA Regulatory Affairs Group. Assist in the planning and coordination of administrative details of regu...
Director of IT Regulatory and Compliance and may reside in either Urbandale, Iowa, Wilmington, Delaware or remote would be available for the right candidate. This role will own ensure our IT Compliance and Cyber Security Risk Assessments continue to align with our IT Regulatory, Data Privacy and Inf...
Compliance Senior Analyst, Independence Consultation - Business Relationships, Independence & Conflicts Network (ICN). Do you have a focus on compliance with regulations and policies? Are you passionate about quality-assurance and risk-management in a professional services environment? Then our ...
The Pharmaceutical Regulatory Affairs Senior Manager will use their experience and knowledge in pharmaceutical industry regulatory affairs to lead and manage complex projects for our clients in the pharmaceutical sector, and provide strategic advice, guidance, and solutions on regulatory matters. Ab...
As a Senior Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. Our Tax Controversy and Regulatory Services team helps our clients navigate the Internal Revenue Service process to facilitate compliance, drive issue resolutio...