- Merck & Co. (North Wales, PA)
- …for projects of increasing complexity.Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change ... Job DescriptionPrincipal Scientist / Director, GLOBAL REGULATORY CMC Biologics (R5)Under general supervision of an Executive Director/Senior Director, the Principal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(GRL Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and ... Years Experience in the pharmaceutical industry7 or more years with direct regulatory affairs experienceExperience in regulatory submissions in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all ... global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions , shortening the review process and leading… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all ... global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions , shortening the review process and leading… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality, reliability, consistency and efficiency.ResponsibilitiesPlan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory ... FDA forms, administrative information, letter of authorization, etc.) for US regulatory submissions .Support FDA meeting preparation including preparation of… more
- Merck & Co. (North Wales, PA)
- …mutually align on co-development needs and expectations for major project tasks such as regulatory submissions (eg, PMAs, 510(k)s, IVDR submissions to NB, ... pre- submissions ).-Reviewing and authoring relevant sections of diagnostic regulatory submissions , as appropriate, and corresponding therapeutic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provides guidance to ROI staff as needed during assembly of regulatory submissions .Advertising and PromotionGain understanding of how prescription drug ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...documents.Work with global stakeholders from headquarters on preparation of submissions to FDA.Assist in review or development of labeling… more
- Eisai, Inc (Exton, PA)
- …strategies throughout the lifecycle of pharmaceuticals. Coordinates the preparation of CMC regulatory submissions that meet global regulatory requirements, ... to improve efficiency. Essential Functions 1. Development Projects Assumes CMC regulatory accountability for clinical development documents (INDs, IMPDs, and CTAs)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provide high level strategic input into development plans, study designs, and regulatory submissions . Relationships The Principal Medical Writer reports to a ... input into documents and plans to support clinical operations and regulatory submissions across a range of development programs and therapeutic areas: Uses… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and meeting preparation Lead and/or support global filing activities for submissions Present regulatory strategies including communication of regulatory ... difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines. You… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendors ensuring that outsourced obligations are in compliant and prepared for regulatory submissions and / or inspections Ensures that appropriate systems, ... and GCLP study protocols, clinical study reports, ICFs, external publications, and regulatory authority submissions (IMPD/IND) Responsible to design the audit… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical industry across multiple therapeutic areas and actively participates in regulatory submissions and inspections. Finally, this position has ... complex clinical trial designs and processes (eg, endpoint adjudication)Experience in regulatory submissions , regulatory inspections, and/or internal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …edits, and provides QC review of documents to support clinical trials and regulatory submissions , which may include: Clinical study protocols and protocol ... Clinical summary and overview documents in eCTD format for global regulatory submissions Shares knowledge and experience to optimize and simplify the way… more
- Tris Pharma (Monmouth Junction, NJ)
- …and critical data and statistical analysis are performedReviews and approves all regulatory submissions and other relevant scientific packages for internal and ... priorities. She/he also reviews and approves all scientific, technical and regulatory packages per International Council for Harmonization (ICH)/Food and Drug… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions , as well as in-house validation of this work. Possesses ... in-depth knowledge of regulatory authority's requirements.Typically has administrative responsibility for recruiting, retaining, developing, and managing employees.… more
- Aequor (Tallahassee, FL)
- …wording for case related data exchange Monitoring compliance in regard to regulatory submissions and/or contractual wording for data exchange Assign tasks ... ensure high quality cases in a timely manner to meet all worldwide regulatory authority requirements Provide vendors with resources and training to perform their… more
- Merck & Co. (Rahway, NJ)
- … Regulatory , Operations, Non-clinical, Clinical, and other functional areasExperience with regulatory submissions including writing / review of regulatory ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Merck & Co. (Rahway, NJ)
- …development, validation, analysis and interpretation of COA endpoints to support regulatory submissions , reimbursement evidence dossiers, payer interactions, and ... Principal Scientist will work closely with individuals from Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations to ensure COA… more
- Merck & Co. (Rahway, NJ)
- …of oral, sterile and combination products. You will also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities will ... lifecycle, as well as responding to agency questions.-Scientific Excellence and Regulatory Influence:Promoting our company's scientific excellence and regulatory … more
- Merck & Co. (Rahway, NJ)
- …figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. The incumbent is ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
