- Sumitomo Pharma (Harrisburg, PA)
- … strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international submissions. In addition, the ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...and experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must be deeply… more
- Bristol Myers Squibb (San Diego, CA)
- …experienced and innovative Director in Regulatory Affairs (clinical and nonclinical). This Global Regulatory Lead (GRL) position will report to the Head of ... and responsibilities include the following. Other duties may be assigned. + Global Regulatory Lead for a cutting edge RPT program + Clinical and nonclinical… more
- Rhythm Pharmaceuticals (Boston, MA)
- …and timely execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. You will provide regulatory ... and life cycle of Rhythm products. This role reports into the Director, Global Regulatory Affairs. Responsibilities and Duties + Act as the Global … more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …in product development teams + Communicate risks and mitigation approaches associated with regulatory strategies + Support global regulatory strategies in ... and completion of regulatory submissions to FDA and other global regulatory agencies + Experience in negotiating with regulatory authority personnel… more
- BeOne Medicines (San Mateo, CA)
- …for product(s) in line with business objectives, and in coordination with the global regulatory leader and key internal stakeholders. This individual will manage ... are met in alignment with the global strategy as determined by the global regulatory leader. + Reviews sections of the documents that will be utilized in the… more
- Citigroup (Tampa, FL)
- The Global Regulatory and Capital Reporting - Reporting Analytics Change Management and Innovation organization is looking for an Analyst / Data Scientist who is ... then culminates with instituting common and optimized financial / regulatory reporting processes. Global Regulatory ...and optimized financial / regulatory reporting processes. Global Regulatory and Capital Reporting - Reporting… more
- Teleflex (Morrisville, NC)
- …and develop program implementation plans. * Manage Technical Documentation. * Manage Global regulatory impact assessments. * Review and assess change control ... Sr Regulatory Affairs Specialist **Date:** Sep 23, 2025 **Location:**...10% **Requisition ID** :12618 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …to department and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and ... while balancing business benefits and risks. + Lead and Manage Global Regulatory Submission Activities: Oversee submission planning, authoring, reviewing,… more
- Organon & Co. (Jersey City, NJ)
- …**The Position** Leading the Regulatory Policy and Intelligence activities for Global Regulatory Affairs covering all Therapeutic Areas and products, as well ... or regions of the world of interest to Organon. **Responsibilities** + Provide Global Regulatory Policy and Intelligence insights to the organization to guide… more
- Organon & Co. (Jersey City, NJ)
- … strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation ... Scientist (Associate Director) is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small… more