- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: This role is responsible for providing regulatory strategic and tactical leadership, and alignment to ways of working on ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Merck & Co. (North Wales, PA)
- …and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional ... practices are consistent with regulatory guidelines, our company's policies, and support business objectives.Serve...emphasis in science, health care or related fields.Preferred: Master's, PhD or PharmD degree with an emphasis in science,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support...of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines… more
- Genmab (Plainsboro, NJ)
- …for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory leader will be primarily ... responsible for the development of global (and US) regulatory strategies (depending on the assigned project/projects) to advance...MSc level degree preferably within the life sciences (PharmD, PhD preferred) Minimum of 3-5 years of hands on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's ... regulatory group in internal and external development project meetings....guidance to peers and cross-functional team members regarding strategic regulatory issues. Develops timeline and strategic input with feedback… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... pharmacometric analyses-Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects, ... of others (team members); meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process… more
- Merck & Co. (Rahway, NJ)
- …proportional hazards models. Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring ... regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs),...(CSRs), clinical trial applications (CTDs)), and representing QP2-IO at regulatory meetings. - Minimum education required: Ph.D. with 1-3… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading ... information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Merck & Co. (Rahway, NJ)
- …formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products ... product technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Merck & Co. (Rahway, NJ)
- …validation, collaborating with project teams, biomarker leaders, clinical operations and regulatory affairs on the implementation of these assays in clinical trials. ... Position Qualifications : Education Minimum Requirement: -BA/MS/ PhD in a life sciences discipline (Biochemistry, Immunology, Molecular Pathology, Cell Biology, etc.)… more
- Aequor (Seattle, WA)
- ScientistLocation: Seattle, WA (100% Onsite)Assignment Length: 12 months contractTop Skills: PhD in immunology, cell biology, or a related discipline (or MS with ... experience is highly desirable, preferably within the biotechnology or pharmaceutical industry. PhD candidate with 0-2 years of experience is highly preferred. A… more
- Lundbeck (Bothell, WA)
- …group and department meetings; draft SOPs, development reports, and regulatory submission documents Provide cross-functional support to upstream/downstream process ... validation at contract labs/CMOs Contribute to analytical sections for regulatory submissions while ensuring high-quality data integrity and documentation… more
- Merck & Co. (Rahway, NJ)
- …external manufacturing sites, manufacturing investigation, process validation, and authoring of regulatory submissions.We are seeking a Senior Scientist to join our ... functional area on cross-functional teams and external collaborations.Author BLA regulatory filings and technical documentationSupport validation of new software and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor ... college or university)- Master's Degree in statistics or biostatistics required- PhD in statistics or biostatistics preferred Experience Qualifications- 8+ Years of… more
- Merck & Co. (Rahway, NJ)
- …college/university plus at least 11 years of relevant work experience in process development or PhD with at least 7 years of relevant work experience post PhD ... scaling calculations, and Quality by Design (QbD) principles.-Experience supporting/writing regulatory filings.Current Employees apply HERE Current Contingent Workers apply… more
