- GRAIL (Montgomery, AL)
- …to project teams and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior management meetings as ... 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 reports,… more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …That Matters.** **Overview** **Purpose Statement/Position Summary:** The Manager, Clinical Research Regulatory Affairs is tasked with oversight and governance of ... Regulatory Affairs department and involved in the day-to-day support of...research subjects. Preferred: 1 year experience supervising and managing staff **Education/Licensure/Certification:** Required: + Bachelor's degree in a related… more
- FleishmanHillard (Washington, DC)
- …a fantastic opportunity to work at the intersection of healthcare and public affairs in service to pharmaceutical and medical device companies, as well as third ... Additional desired areas of expertise include issues advocacy and public affairs campaigns, strong writing skills, and stakeholder engagement with policy and… more
- GRAIL (Washington, DC)
- …more information, please visit grail.com GRAIL is seeking a seasoned federal government affairs leader to shape and execute our engagement strategy in Washington, DC ... role will elevate GRAIL's visibility among policymakers, advance legislative and regulatory frameworks that support early cancer detection, and strengthen alliances… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …scientific information in a timely, ethical and customer-focused manner, following regulatory and compliance guidelines of the company. + Provide disease education ... the overall strategic focus of the Medical and Scientific Affairs team by communicating clinical and research insights and...personnel, as well as aide in training of SUN staff . **Qualifications** + Scientific degree required (PharmD, MD, DO,… more
- Lundbeck (Deerfield, IL)
- …Opportunity - Open to candidates within the United States** The Director, US Regulatory Affairs Strategy, oversees the implementation of regulatory ... and Lundbeck product development programs. + Trains, develops, and manages an effective regulatory affairs cross-functional team on a dotted-line basis (CMC, … more
- Lundbeck (Deerfield, IL)
- …open to candidates in the greater United States** **SUMMARY:** The Director, US Regulatory Affairs Global Strategic Labelling will lead and oversee the ... and development products/programs. + Trains, develops, and manages an effective regulatory affairs cross-functional team on key labelling requirements (CMC,… more
- Seattle Children's (Seattle, WA)
- …part 11 validation and compliance. Recognized certification in Quality Assurance or Regulatory Affairs . Proven audit experience in GCP. **Compensation Range** ... to the Seattle Children's Research Institute in quality analysis and regulatory support for clinical research. Leads overall business planning and direction,… more
- embecta (Parsippany, NJ)
- …within the organization. Creates/manages product Plans/PSURs in collaboration with Medical/ Regulatory Affairs , R&D, Customer Service, and others. Leads ... As directed by the Director of Quality, the Post-Market Surveillance Staff Quality Engineer is accountable for supporting the continuing development, improvement,… more
- Expand Energy Corporation (Spring, TX)
- …or related field ## **Experience** + Minimum: 8 years experience in energy policy, regulatory affairs , or a related field, with experience in downstream markets ... the United States\. **Nearest Major Market:** Houston **Job Segment:** Compliance, Regulatory Affairs , Sustainability, Geology, Public Policy, Legal, Energy,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …between Sales and Marketing, R&D, PMO, HEMA, Risk Management, Quality and Regulatory Affairs , and investigational sites. + Ensures clinical studies are ... **Job Description** This role collaborates closely with the leadership of Clinical Affairs to execute clinical strategy activities and oversee aspects of clinical… more
- Washington Metropolitan Area Transit Authority (Alexandria, VA)
- …**Education** + Bachelor'sdegreeinBusinessManagement,PublicRelations,Communications,Public Administration, Public Affairs , or other related fields. **Minimum** ... **Experience** + Aminimumofeight(8)yearsofprogressivemanagementexperienceincludingthesupervisionof staff in a customer service and/or operations control center… more
- BeOne Medicines (Pennington, NJ)
- …international regulations. The position requires strong cross-functional collaboration with Regulatory Affairs , Process Development, Manufacturing, and Quality ... written support for Investigational New Drug (IND) submissions and other regulatory documentation. + Coordinate and schedule analytical testing, ensuring thorough… more
- ALBEMARLE (Charlotte, NC)
- …organization (Product Management, Pricing, Data Science, NBD, R&T, Marketing, Sales, External Affairs , etc.) to inform the strategy development as well as monitor ... the enterprise, encompassing go-to-market, pricing, product portfolio, innovation, assets, regulatory , customer experience, and strategic partnerships. Devise and execute… more
- ALBEMARLE (Charlotte, NC)
- …organization (Product Management, Pricing, Data Science, NBD, R&T, Marketing, Sales, External Affairs , etc.) to inform the strategy development as well as monitor ... the enterprise, encompassing go-to-market, pricing, product portfolio, innovation, assets, regulatory , customer experience, and strategic partnerships. Devise and execute… more
- Hawaiian Electric (Honolulu, HI)
- …Electric Companies, including in operations, engineering, planning, community relations, and regulatory affairs . + Evaluates and selects large complex or ... in Planning and Technology, Energy Delivery, System Operation, Power Supply, Regulatory , Government and Community Relations, and Legal to optimize processes and… more
- Olympus Corporation of the Americas (Westborough, MA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... supports business objectives through: proactive monitoring and application of global regulatory requirements within the regional QMS; leading the governance of the… more
- BeOne Medicines (San Mateo, CA)
- …can be in drug development, clinical operations, clinical quality assurance, medical affairs , clinical regulatory compliance or a related field. **Other ... reports, as applicable. + Conducts regular one-on-one and any other staff meetings to ensure timely communication with indirect/direct reports. Provides feedback… more
- IQVIA (Washington, DC)
- …Analysis & Development** **Design, Review & Implement Pre-Clinical Testing** **Manage Regulatory Affairs staff , facilitate professional development and ... Join our team to help shape the future of MedTech.** **Overview** **The Director, Regulatory Affairs , EMC/Robotics will be a critical team member supporting … more
- Penn Medicine (Philadelphia, PA)
- …goals and regulatory requirements. Provide day-to-day management and mentorship to regulatory affairs staff . + Policy Alignment: Ensure alignment of ... + Hours: 8hr Days **Summary** : The Senior Corporate Director of Regulatory Affairs for Penn Medicine provides leadership and strategic direction across the… more
