- Spark Therapeutics Inc. (Philadelphia, PA)
- Regulatory Strategy Lead **Date:** Oct 11, 2024 **Location:** Philadelphia, PA, US, 19104 **Company:** Spark Therapeutics Join the Spark Team We were born of ... managing IND submissions, marketing application and post-approval submissions, as appropriate. The Regulatory Strategy Lead works to coordinate interactions… more
- JPMorgan Chase (New York, NY)
- … lead and other exam partners in preparation for, and engagement in, regulatory engagements. + Lead regulatory examinations through the exam lifecycle, ... Bank, Treasury & Chief Investment Office & Corporate Finance Regulatory Engagement team, you will have a lead...will be responsible for the execution of the overall strategy for regulatory engagements. In this role,… more
- Amgen (Washington, DC)
- …guidance to product teams **Key Responsibilities include:** + Develop and execute the global regulatory product strategy + Lead Global Regulatory Teams ... Amgen molecules. In this vital, product-facing role you will lead the Global Regulatory Team (GRT) in...Regulatory Affairs department + To develop a comprehensive regulatory strategy that takes into account worldwide… more
- Robert Half Finance & Accounting (Wilmington, DE)
- …issues . Create and implement corrective action plan . Develop and implement a comprehensive regulatory reporting strategy . Lead and manage a team of ... services industry, is looking to hire a Director of Regulatory Reporting who can oversee and manage the ...Regulatory Reporting who can oversee and manage the regulatory reporting function within the organization. In this role,… more
- Takeda Pharmaceuticals (Boston, MA)
- …in regulatory filings through clinical development and commercial product lifecycle + Lead regulatory strategy , briefing book authoring and meetings with ... and effective, collaborate with GRA Liaisons, GRA CMC Leads and other regulatory functions, driving drug-device combination strategy + Active participation in… more
- Actalent (Parsippany Troy Hills, NJ)
- …will lead our regulatory submissions as well as preside over the company's regulatory strategy . The position will lead the regulatory affairs and ... standards on both US and global bases. Responsibilities + Lead , manage, and coordinate regulatory activities for...Business, and Commercial teams. + Develop and implement a regulatory strategy for pipeline projects, evaluate new… more
- AbbVie (Irvine, CA)
- …for future opportunities. The Director Regulatory Affairs Global Regulatory Lead , Global Regulatory Strategy , is responsible for developing and ... strategic messaging and content of global regulatory dossiers. + May lead the Labeling Regulatory Strategy Team (LRST), and serve as the primary … more
- AbbVie (North Chicago, IL)
- …LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead , Global Regulatory Strategy , is responsible for developing and ... strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …integrated into Pharmaceutical Development & Manufacturing (PDM) Project teams. **Job Description:** + Lead CMC regulatory strategy for a single or multiple ... Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more molecules...to assure approvability in high priority regions. As a regulatory lead you will also be responsible… more
- BeiGene (San Mateo, CA)
- …assess the impact to applicable safety documents or safety section of clinical or regulatory documents. + Lead strategy development, analysis, and response ... the ability to understand and communicate scientific issues and strategy + Lead execution of signal assessment...Lead Safety Science specific investigator training **Risk Assessment, Regulatory Inquiries, and Periodic Reporting** + Lead … more
- Meta (Burlingame, CA)
- …Labs is seeking an experienced medical devices regulatory affairs professional to lead the regulatory strategy and product approvals for novel hardware ... software as a medical device (SaMD). **Required Skills:** Head of Medical Devices Regulatory Affairs Responsibilities: 1. Lead project teams for end-to-end … more
- Takeda Pharmaceuticals (Boston, MA)
- …with changing regulatory and business needs and anticipates such changes to lead adaptations to regulatory strategy . + Ensures project team colleagues, ... patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead , GI & Inflammation where you...to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring… more
- AbbVie (North Chicago, IL)
- …(AST) and ensures CMC strategy is closely aligned with the clinical and regulatory development strategy . May lead multiple PPDST/CMC teams from GLP tox ... PDD(s) and/or develops and implements PM or training tools. Lead R&D wide or DevSci wide initiatives and strategies...and device technical information in conjunction with the project strategy , with full consideration of current regulatory … more
- Citigroup (Washington, DC)
- …policy positions, including in connection with industry comment letters and consultations. + Lead the development regulatory strategy and advocacy briefing ... Policy Analyst will be a part of Citi's Global Regulatory Strategy & Policy team and report...ad hoc meetings to discuss policy developments and advocacy strategy . + Lead the development of internal… more
- AbbVie (North Chicago, IL)
- …This is a role for a visionary leader with a passion for scientific excellence and regulatory strategy . Key Responsibilities + Lead and develop a team of ... Description The Senior Director of CMC Dossier Leadership will lead an experienced team responsible for the creation and...management of high-quality CMC submission strategies and Module 3 regulatory documents. Reporting to the VP CMC Strategy… more
- Lilly (Indianapolis, IN)
- …increasing Lilly's visibility and influence of evolving regulatory positions. ** Lead / Partner** * Leads communication strategy for affiliates and/or ... provides interpretation and internal communication as appropriate * Leads technical and regulatory review forums, to evaluate submission strategy and/or data… more
- Momentive Performance Materials Inc. (OH)
- …board. You'll partner closely with Business Teams to facilitate new product development, lead Regulatory Strategy Forums, and execute product registration ... Include: Business Segment Partnership + Actively leads, participates, and supports Regulatory Strategy Forums and Application Reviews and implements Product… more
- Boehringer Ingelheim (Ridgefield, CT)
- …& Responsibilities** Regulatory Expertise: The Fellow will develop basic regulatory strategy expertise/knowledge in one or more therapeutic areas. Interact ... provide leadership in the development and implementation of US regulatory strategy within a global development context....as appropriate, in preparing responses to FDA requests. + Lead FDA meetings for assigned projects + Disseminate FDA… more
- AbbVie (North Chicago, IL)
- …Affairs Strategy roles (US and Canada) are: 1. Responsible for providing regulatory strategy & support for global development. 2. Responsible for supporting ... products within a Therapeutic Area & support the Global Regulatory Lead (GRL) & Therapeutic Area Head...Area Head with the development & execution of the regulatory strategy . 7. Serve as HA liaison… more
- JPMorgan Chase (New York, NY)
- Bring your expertise to JPMorgan Chase. As part of the Regulatory Strategy Chief Data & Analytics Office (including AI) Team, you are at the center of keeping ... to be best-in-class. As a Vice President within the Regulatory Strategy Chief Data & Analytics Office...and developing reports for senior management. **Job responsibilities** + Lead regulatory examinations impacting the CDAO through… more