Director, Regulatory Affairs, Immunology. A company is looking for a Director / Sr. ...
Develop and implement regulatory strategies, including regulatory risk management, ensuring that any RA issues are highlighted and addressed satisfactorily and in a timely fashion. PhD/PharmD with 7+ years’ experience in Regulatory Affairs or BS/MS with 10+ years’ experience. Supports the department...
A company is looking for a Regulatory Affairs and Compliance Director (Remote). ...
Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market. Collaborate with various regulatory consultants, clinical advisory board members, and board members to maintain regulatory knowledge...
Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market. Collaborate with various regulatory consultants, clinical advisory board members, and board members to maintain regulatory knowledge...
Establishes processes and measures to monitor conformance with Regulatory Affairs procedures and compliance with regulatory requirements. Interpret regulatory intelligence to assess the impact on Exelixis and advise Regulatory Affairs leadership accordingly. Establish process and measures to ensure ...
Director, Regulatory Affairs and Quality Project Management. The Director of Regulatory Affairs and Quality Project Management must thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, effective, and efficient. This position will report to the Senior Direc...
Liaises cross-functionally with partners in Commercial, Medical Affairs, Regulatory, Legal, Public Relations, and others to develop holistic strategies around communication initiatives, working within the regulatory framework and boundaries. Provides leadership within the Regulatory department, iden...
Establishes processes and measures to monitor conformance with Regulatory Affairs procedures and compliance with regulatory requirements. Interpret regulatory intelligence to assess the impact on Exelixis and advise Regulatory Affairs leadership accordingly. Establish process and measures to ensure ...
Associate Director/Director, Regulatory Affairs. Execute global Regulatory strategies across nonclinical, clinical, quality and CMC functions, for gene editing therapies, ensuring alignment with corporate objectives/timelines and regulatory compliance. Help prepare, draft and review of regulatory do...
Furthermore, the successful candidate will have demonstrated knowledge of regulatory requirements and guidelines, the ability to apply their knowledge to daily work, and the ability to represent regulatory affairs as part of an interdisciplinary team. Calcilytix San Francisco, CA/Hybrid Regulatory A...
Associate Director Regulatory Affairs – US New Product Introduction and On-Market Changes. The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop regulatory submission strategy, and provide executive mana...
The firm is looking for a senior director of fintech legislative and regulatory affairs, for global clients, expanding in the Middle Eastern economies. Preferred field(s) of study: International business legislative and regulatory affairs. The selected candidate will develop Web3 and fintech regulat...
Vir Biotechnology is seeking a highly motivated, self-driven and enthusiastic Senior Director of Regulatory CMC accountable for ensuring all assigned products have a successful regulatory CMC strategy for clinical development and commercialization. This position will work closely with the Technical ...
As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Associate Director Regulatory Affairs – A...
Kyverna is seeking an experienced and passionate Associate Director, CMC Regulatory Affairs with a strong background in cell and gene therapy, preferably CAR T therapy. Author and/or review high quality CMC sections for global regulatory submissions (IND/CTA, and BLA/MAA), applying agreed CMC global...
Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market. Collaborate with various regulatory consultants, clinical advisory board members, and board members to maintain regulatory knowledge...
Lead regulatory strategy, provide regulatory guidance/precedents; identify, assess, and mitigate regulatory risks. Monitor regulatory agency activities in the relevant space and maintain a global perspective on regulatory strategy. Regulatory Affairs in biopharma industry or equivalent. Providing re...
Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market. Collaborate with various regulatory consultants, clinical advisory board members, and board members to maintain regulatory knowledge...
Associate Director Regulatory Affairs – US New Product Introduction and On-Market Changes. The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop regulatory submission strategy, and provide executive mana...
Provides leadership within the Commercial Regulatory Affairs department, identifying and managing through completion departmental and cross-project initiatives and regulatory obligations. Responsible for the regulatory review and approval of scientific exchange materials, including Medical Informati...
Innova Solutions is immediately hiring for an Associate Director, Regulatory Affairs. Associate Director, Regulatory Affairs , you. In collaboration with Regulatory Affairs functional management, coordinate the provision of resources from the various Regulatory functions in support of clinical studi...
Lead the development of wholesale market design policy within Calpine and represent Calpine before FERC, the California ISO and other western regulatory agencies, as needed. Develop and act upon policy positions in wholesale market regulatory arenas. Provide testimony and participate as needed in re...
Provides high level strategic and operational regulatory leadership and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in domestic and international markets, regulatory strategic development plan...
We are actively seeking an experienced professional to join our team as Director of Governmental and Regulatory Affairs at Calpine. Minimum of 8 years of experience in government affairs, regulatory affairs, or a related field in the energy industry. You will help to lead our efforts in navigating t...