- GRAIL (Annapolis, MD)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior...of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties… more
- Parexel (Annapolis, MD)
- …FDA regulatory requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate , you will serve as the ... and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge of… more
- Sumitomo Pharma (Annapolis, MD)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director, Regulatory Affairs (Oncology).** The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...Comfortable presenting to all levels of the organization including Senior Management. **Education and Experience** + Bachelor's degree in… more
- Humana (Washington, DC)
- …help us put health first** The role of Director, Federal Government Affairs involves direct engagement with Senate, House, and/or Administration officials and staff ... years of professional experience in Senate, House, Administration, government affairs , campaign, health policy and/or advocacy roles. Positions within committee,… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... The Associate Director of Regulatory Intelligence leads...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- United Therapeutics (Annapolis, MD)
- …communication with teammates and appreciate the opportunity to collaborate with senior management, CPLs, MSL Field Directors, MSLs, Medical Communications and ... (slides, FAQ, talking points etc.) + Partner with Global Medical Affairs /product development, and global partners' subject matter experts to develop/execute disease… more
- Amgen (Washington, DC)
- …12 years of directly related experience **Preferred Qualifications:** + Experience with regulatory documents in Regulatory Affairs , Research, Development or ... time for a career you can be proud of. ** Regulatory Writing Senior Manager** **Live** **What you...degree and 8 years of directly related experience OR Associate 's degree and 10 years of directly related experience… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs , ... The Associate Director, Scientific Communications manages the execution of...consistency, and compliance. This position reports directly to the Senior Director, CNS Medical Communications Lead. **Key Responsibilities Include:**… more
- Amgen (Washington, DC)
- …transform the lives of patients while transforming your career. **Advocacy Relations Senior Manager, Respiratory** **What you will do** Let's do this. Let's change ... the world. In this vital role the Advocacy Relations Senior Manager, Respiratory will lead the execution of Amgen's...on education and access. + Partner closely with Medical Affairs , Commercial, Access, Corporate Affairs , Government … more
- Internal Revenue Service (Washington, DC)
- …Careers Site Meet Our People Learn about our Legal Divisions Responsibilities The Senior Level Counsel (SLC) serves as a national expert and confidential advisor, to ... the Associate Chief Counsel, Procedure and Administration (P&A); and represents...the highest complexity and impact. Major duties of the Senior Level Counsel include, but are not limited to… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, ... team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + Familiar… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …a technical leader within a matrixed organization. + Collaborate with Supply Chain, Regulatory Affairs , IT, and other functions to ensure integrated quality ... **Job Summary** The Associate Director, Quality Operations will lead initiatives that...on key risk indicators and escalate critical risks to senior leadership. **Global Quality System Processes** + Oversee the… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product ... all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate. + Collaborate with global… more
- Newell Brands (Annapolis, MD)
- …a related field. + 3-5 years of experience in tax incentives, government programs, regulatory affairs , or a related area (internships or co-op experience may be ... and collaborative environment where you can be your best, every day. The Associate Manager, Tax Incentives & Grants will support the Manager in identifying,… more
