- M&T Bank (Buffalo, NY)
- …solutions. The position ensures alignment with both economic and regulatory requirements, while driving strategic risk governance and cross-functional ... Capital Review. + Evaluate and enhance controls related to Regulatory Reporting risk and other Finance processes. + Oversee...and liquidity risk. + Represent IRM on senior committees ( CMC , Executive ALCO, MRC) and provide updates to Governance… more
- ThermoFisher Scientific (Greenville, NC)
- …of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. + ... Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant… more
- Otsuka America Pharmaceutical Inc. (Waltham, MA)
- …endpoints ensuring seamless integration across discovery, nonclinical, clinical pharmacology, regulatory , and commercial functions. As an industry-leading expert and ... not limited to Translational Research & Biomarkers, Clinical Management, Global Regulatory Affairs, Global Clinical Development (late phase), Data & Analytics, Early… more
- Lilly (Indianapolis, IN)
- …+ Ensure process definition of critical parameters are in alignment with regulatory submission. + Ensure that each of the department and external partner ... operate in compliance with cGMPs, regulatory commitments and Lilly Functional Standards though appropriate oversight. Ensure inspection readiness at all times. +… more
- Boehringer Ingelheim (Gainesville, GA)
- …etc. + Provides technical input and support for questions received from Regulatory Authorities in various regulatory processes, eg geographical expansion of ... and/or provides ad-hoc support to Global Supply Lead (by topic) of CMC Development sub-team. + Provides technical guidance and recommendation for user requirements,… more
- Boehringer Ingelheim (Athens, GA)
- …etc. + Provides technical input and support for questions received from Regulatory Authorities in various regulatory processes, eg geographical expansion of ... Expert or Project Contributor: + Provides support to Operations Lead of CMC Development sub-team. + Technical assessment of user requirements, product or process… more
- BeOne Medicines (Pennington, NJ)
- …regulations. The position requires strong cross-functional collaboration with Regulatory Affairs, Process Development, Manufacturing, and Quality teams, as ... written support for Investigational New Drug (IND) submissions and other regulatory documentation. + Coordinate and schedule analytical testing, ensuring thorough… more
- Merck (Rahway, NJ)
- …state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls ( CMC ) hub at our site headquarters in Rahway, NJ. This facility will be ... + Ensure areas of accountability are delivered in accordance with EHS regulatory and company EHS requirements. + Build robust communication channels with site… more
- J&J Family of Companies (Malvern, PA)
- …drive development strategy and execution. + Responsible for shaping external regulatory strategy through direct projects with health authorities, engagement on ... Support (10 products). Provide support in >100 countries + 20% -- Global Regulatory filings for product licensure and Shaping external Regulatory environment +… more
- Merck (West Point, PA)
- …worldwide. PCT leads process development as products enter Phase IIb through regulatory filings, process validation, and for several years beyond commercial launch. ... to commercial scale. Partners include research and development, analytical, regulatory , quality, packaging, and operations at our commercialization and commercial… more