Job Title: Regulatory & Quality Compliance Manager (m/f/d) Job Location: Waltham, MA, USA Job Location Type: Remote... Manager (m/f/d) - Sterile Fluids (Medicinal Products). Main Responsibilities: Support as regulatory expert development...
(DS), drug product (DP) and analytical development, DS/DP clinical manufacturing, and support of global regulatory filings...
Associate/Director, Regulatory Affairs will join a group of highly motivated, top-notch regulatory professionals... and will be a key player in shaping cohesive regulatory strategies across the product pipeline. The Associate/Director, Regulatory...
to join our Regulatory Strategy team. As Senior Director of Regulatory Affairs, the successful candidate will play an important role... as a Regulatory Lead for pipeline drug development programs and marketed products, and will be responsible for developing...
. Job Purpose To support MA DER regulatory initiatives, program management and communications to ensure prioritization of efforts... Serve as the single point of contact for regulatory conversations, keeping detailed record of notes, action items, decisions...
to join our Regulatory Strategy team. As Associate Director of Regulatory Affairs, the successful candidate will play an important role... with applicable regulatory requirements. The ideal candidate will have a strong scientific background, and be able to leverage...
and regulatory compliance matters locally, nationally, and internationally as a subject matter expert, including the ongoing... on ethics and regulatory compliance matters. As needed, direct engagement with government officials. Design, establish...
and regulatory compliance matters locally, nationally, and internationally as a subject matter expert, including the ongoing... on ethics and regulatory compliance matters. As needed, direct engagement with government officials. Design, establish...
Job Title: Manager, Regulatory Affairs Job Location: United States Job Location Type: Remote Job Contract.... If this sounds like you, keep reading! Role Summary We are seeking a Manager, Regulatory Affairs. This newly created role offers...
Responsibilities: The Director of Regulatory Affairs will be responsible for the preparation and management of ANDA... submission and oversee and manage all ANDA regulatory activities pre- and post- submission. This role is critical in ensuring...
DIRECTOR/SENIOR DIRECTOR OF REGULATORY CHEMISTRY, MANUFACTURING, AND CONTROLS (CMC) Company Overview: Mythic... therapy. Job Summary: Mythic Therapeutics is seeking a Director/Senior Director of Regulatory Chemistry, Manufacturing...
, Manufacturing, and Controls (CMC) Regulatory Affairs supports a portfolio of small molecule development programs and marketed... excellence, and collaboration at every opportunity. The Associate Director of CMC Regulatory Affairs will support post-approval...
knowledge of compliance and regulatory rules, regulations, and best practices in the field as an MSL and/or Managed Care Liaison...
Liaise with Regulatory Affairs on any manufacturing process changes that may impact regulatory filings Collaborate with CMC... to continually improve compliance with quality systems, internal SOPs, and regulatory requirements and to resolve minor and major...
projects by external vendors to ensure milestones are met Develop and/or maintain regulatory style guide and Medical Writing... as a regulatory or medical writer, with at least 2 years of global clinical trials transparency/disclosure process and strategy...
and regulatory requirements. Clinical Development: Oversee clinical trials and ensure compliance with regulatory standards... to inform strategic decision-making. Regulatory Affairs: Collaborate with regulatory bodies to ensure all products meet...
, changes in policies, and meet regulatory requirements from DPH Maintains a calendar of educational programs and makes it...
and regulatory requirements Ensure GMP training status for team members for readiness and compliance Investigate and resolve... experience handling iPSC’s is strongly desired Experience operating under regulatory requirements, Code of the Federal...
healthcare, tax and accounting, financial and corporate compliance, legal and regulatory, and corporate performance and ESG...
according to all regulatory agencies and departmental policies and procedures. 7.   Maintains records of journals and books contained in the...