- Regenxbio Inc. (Rockville, MD)
- …matters - to patients, to their families, and to their communities. The opportunity The Regulatory Affairs department at REGENXBIO is excited to be adding a new ... PharmD or PhD in biological sciences preferred At least 3-7 years in Regulatory Affairs , preferably in industry and including project management experience… more
- Immunocore Limited (Rockville, MD)
- …requests for medical/ scientific information. Support review committees for medical affairs input and review, partnering closely with Regulatory , Legal and ... of Medical Affairs . The Director , Medical Affairs Lead will lead scientific and medical...Medical Science Liaisons, working in close collaboration with the senior MSLs to develop the US MSL Medical objectives.… more
- Advanced Medical Technology Association (Washington, DC)
- …President, Technology & Regulatory Affairs Department: Technology & Regulatory Affairs (04) Supervisor: Senior Executive Vice President, Technology ... & Regulatory Affairs FLSA Status: Exempt Purpose of Position To advance...To provide substantial expertise, assistance and representation on technical, regulatory , and scientific issues related to medical… more
- Emergent BioSolutions (Gaithersburg, MD)
- …, technical and professional skills to develop products designed-to protect life. Senior Counsel - Legal Regulatory and Compliance provides legal support ... trials, and regulatory , quality, and pharmacovigilance agreements. Provide regulatory support for clinical development and medical affairs activities… more
- Germer International (Rockville, MD)
- …plan, which includes activities in biopharmaceutical process development, manufacturing, quality and regulatory affairs . The Sr. Project Manager for CMC also ... Qualifications Education & Credentials Bachelor's degree in a relevant technical or scientific discipline Experience Sr. Project Manager At least 7 years' experience… more
- Precision Medicine Group (Frederick, MD)
- …will be responsible for applying expert knowledge and in-depth knowledge of the regulatory affairs and marketing authorization process for small and large ... objectives and other relevant industry trendsStay abreast of the latest regulatory and scientific developments in the marketplace that will impact the line of… more
- Precision Medicine Group (Frederick, MD)
- … Senior Consultant applies expertise and in-depth knowledge of science, regulatory affairs , and product development to coordinate and execute strategies ... objectives and other relevant industry trendsStay abreast of the latest regulatory and scientific developments in the marketplace that will impact the line of… more
- AstraZeneca GmbH (Gaithersburg, MD)
- …HEOR - US Oncology role sits within the United States the Global Medical Affairs (GMA) organization and interacts with Payer, Medical and Commercial teams to design ... evidence to assist payer and health care provider (HCP) decision-makers and include scientific evidence for reimbursement dossiers and market access in the US. This… more
- World Wildlife Fund (Washington, DC)
- …Fund (WWF), one of the world's leading conservation organizations, seeks a Senior Policy Lead, No Plastics in Nature Focused on developing, coordinating, and ... plastic production and waste management. In consultation with the Director of Government Affairs and Advocacy, contributes as needed to achieve a core set of… more
- Aequor (Thousand Oaks, CA)
- …biologics and small molecules, commercial and clinical is highly desired. Overview The Senior Associate Regulatory Affairs (CMC) provides varying levels of ... product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions... (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience o OR o Bachelor's degree and 4… more
- Merck & Co. (North Wales, PA)
- …(eg, CCDS, CCPPI, CCIFU) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU Labeling ... requirementsserving as regulatory labeling point of contact on global Regulatory Affairs sub-teams to ensure delivery of labeling documents that meet… more
- Merck & Co. (North Wales, PA)
- …questions per established business processes and systems.-Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit ... vaccinated as a condition of employment.Accountable for the delivery of all regulatory milestones for higher complexity products through the product lifecycle in… more
- Merck & Co. (North Wales, PA)
- …the departmental move to Rahway, NJ will be communicated at a future date.Our Regulatory Affairs team bring new medical advancements to the world by facilitating ... procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the directing edge of...You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse… more
- Heska (Rockville, MD)
- …management of the manufacturing and warehouse operations.ESSENTIAL DUTIES AND RESPONSIBILITIES: Regulatory Affairs and Quality Duties: Responsible for overall ... complete allergy solutions from testing and interpretation to immunotherapeutic options.The Senior Manager of Manufacturing Operations is responsible for driving and… more
- American Chemistry Council, Inc. (Washington, DC)
- …standard setting organizations, relevant businesses, and internal ACC departments/divisions (eg, Federal Affairs , State Affairs , and Regulatory and Technical ... Affairs ). Serves as a member of the ACC senior management team and maintains responsibility for ensuring the coordination and alignment of Sustainability and… more
- Emergent BioSolutions Inc. (Gaithersburg, MD)
- …research and development, market research, forecasting, global brand commercial team, legal, regulatory , corporate affairs , and medical affairs team members ... opportunities. Here, you will join passionate professionals who advance their scientific , technical and professional skills to develop products designed-to protect… more
- Takeda Pharmaceuticals International GmbH (NY)
- …your future at Takeda. Join us as a Senior Director , Global Regulatory Portfolio Lead, Global Regulatory Affairs in Cambridge remotely. Here, everyone ... an Senior Director working on the Global Regulatory Affairs Oncology team, you will be... issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific… more
- Horizon Therapeutics (Buffalo Grove, IL)
- …in the biopharmaceutical or related industries, with at least 3 years of Regulatory Affairs advertising and promotion experience. (Fellowship experience may be ... potential, we help others live up to theirs. Position Summary: Provide a regulatory review of communications about Horizon's marketed products and disease areas to… more
- Kriya Therapeutics (Morrisville, NC)
- …vision, and a meaningful purpose, Kriya is the company for you. Position Summary:The Senior Director, Regulatory Affairs is accountable for leading the ... a group of products of increasing complexity within the regulatory affairs portfolio. The Senior ...high profile development program. Successful contribution to a major regulatory approval at a global level. A scientific… more
- Tavanta Therapeutics Inc. (Philadelphia, PA)
- Director/ Senior Director, Regulatory Affairs - CMC Location: Philadelphia, PA Job Description JOB TITLE Director/ Senior Director, Regulatory ... - CMC REPORTS TO Vice President, Head of Regulatory Affairs POSITION SUMMARY Tavanta Therapeutics is...for leading the development and implementation of global CMC regulatory strategies and authoring scientific and … more
