advances to patients who live with genetic diseases. As a Senior Manager in the Regulatory CMC department this individual..., and meet all relevant requirements. Collaborating and alignment with Reg CMC Product Lead regarding change record...
to achieve the next wave of breakthroughs. The Manager CMC Regulatory Affairs is responsible for CMC technical document review... of investigational and marketing applications. Partner with cross-functional stakeholders to deliver regulatory dossiers (e.g. CMC...
must be PST - West Coast California As a Senior Manager in the Regulatory CMC department this individual will be responsible.... Collaborating and staying aligned with Reg CMC Product Lead to assess change records of proposed manufacturing changes and provide...
regulatory requirements. Partners with CMC teams during the development of early-phase CMC control strategies. Implement well...-defined, efficient processes for preparation of these CMC documents. Responsibilities: Authors data-rich sections of INDs...
Responsibilities: Provides CMC regulatory support and guidance to project teams for clinical development and post... approval changes; defines CMC regulatory submission strategies during development and post approval. Experienced with clinical...
and authoring Dossiers. Ensure the submission of CMC documentation supporting clinical trial applications and marketing submissions... mentorship (Regulatory Plans) to internal and external customers for our Drug Product business in Bend (US). Collaborate...
As part of Arxada's Consumer Microbial Control (CMC) division, the Global Product Manager (GPM) will handle the product..., Regulatory) with outbound functions (e.g., Sales, Marketing) for relevant assets and product platforms across all global markets...
vector service, ProBio has a stable and high-yield viral vector platform. Job Scope: The Sr. Global Product Manager..., and managing product lifecycle and pricing. Reporting to: Head of Protein & Antibody Product Marketing Team Please note...
opportunity to be part of a team that is shaping the future of CMC Electronics. As Sales Manager, US, your key responsibilities... teams to deliver customer satisfaction, offering feedback for product improvements, and supporting targeted marketing...
solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing... vector service, ProBio has a stable and high-yield viral vector platform. Job Title: Manager of Market Insights for New...
, Market Access- The Field Reimbursement Manager (FRM) ensures seamless access to Treosulfan by supporting oncology hospitals... collaborates with internal teams—including Sales, Marketing, and Market Access—to deliver exceptional customer support. This role...
product development, approval, and post-marketing compliance. The ideal candidate will have a strong understanding... preparation for CMC, Clinical, and Nonclinical Modules, ensuring successful and timely global marketing application submissions...
with multiple myeloma who have received at least one prior therapy. Nexpovio’s marketing authorization is valid in the EU Member... in several clinical trials in metastatic breast cancer disease, alone or in combination with other therapies. A Marketing Authorization...
Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products). Main Responsibilities: Support as regulatory expert...Job Title: Regulatory & Quality Compliance Manager (m/f/d) Job Location: Knoxville, TN, USA Job Location...
Job Title: Regulatory & Quality Compliance Manager (m/f/d) Job Location: Waltham, MA, USA Job Location Type: Remote... Job Contract Type: Full-time Job Seniority Level: Mid-Senior level The internal Job Title is called Global Product Center...
it's what's inside that counts There's more to CMC than our products and the buildings, structures, and roads... they go into. At CMC, it's the people inside our recycling centers, fabrication plants, manufacturing facilities, steel mills...
pharmaceutical industry. Strong background in CMC aspects of drug product registration, knowledge of U.S. drug registration (NDA... and approved applications. Lead, guide, and train the CMC team to ensure highly qualified personnel that can perform to meet...
. Strong background in CMC aspects of drug product registration, knowledge of U.S. drug registration (NDA, ANDA, DMF & INDs... and approved applications. Lead, guide, and train the CMC team to ensure highly qualified personnel that can perform to meet...
regulatory team in the generic pharmaceutical industry. Strong background in CMC aspects of drug product registration, knowledge... and approved applications. Lead, guide, and train the CMC team to ensure highly qualified personnel that can perform to meet...
and Pharma manufacturing systems. Provide both technical and project management support as needed for CMC and packaging projects... with R&D Drug Development, iCMC, IA packaging sites, component, material and equipment suppliers, Regional Marketing...