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Keywords: Associate Director, Regulatory CMC Compliance, Location: USA

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(Associate) Director/Senior Director, Regulatory Affairs, Therapeutics

Mammoth BioSciences OPPORTUNITY Mammoth is hiring a(n) (Associate) Director/Sr. Director, Regulatory Affairs... (Associate) Director/Sr. Director will oversee and partner with several external consultants in the short term. In the longer...

Location: Brisbane, CA
Posted Date: 08 Mar 2025

Associate Director, Regulatory CMC Compliance

Job Description: Overview The Associate Director, Regulatory Compliance will help develop and drive department-wide... global regulatory compliance strategies, with input from key program, Regulatory, Quality and CMC stakeholders. These...

Location: USA
Posted Date: 09 Mar 2025

Associate Director, Regulatory Affairs CMC

. Job Description We are seeking an Associate Director, Regulatory Affairs CMC candidate to sit at our Foster City, CA site. Responsibilities: The... CMC Regulatory Affairs Associate Director at Gilead is responsible for providing strategic direction, operational support...

Company: Gilead
Location: Foster City, CA
Posted Date: 07 Feb 2025

QA Associate Director, CMC Regulatory Submission QC and Audit

Job Description The QA Associate Director, CMC Regulatory Submission QC and Audit, is responsible for the audit.../review of all regulatory submissions in support of submission readiness for small molecule, biologics, and medical devices...

Location: Boston, MA
Posted Date: 18 Jan 2025

Associate Director, Regulatory Affairs - CMC

you to apply to jobs of interest and we will review applications upon our return.” Position Summary The Associate Director, CMC Regulatory Affairs... Executive Director, CMC Regulatory Affairs. Responsibilities Interpret global regulations and guidance to identify risks...

Company: AstraZeneca
Location: Santa Monica, CA
Posted Date: 26 Dec 2024
Salary: $128651 - 192977 per year

Associate Director, Regulatory Affairs Vaccines CMC

regulations to ensure CMC compliance within the organization Leads regulatory compliance assessments with respect to filing... Provides program leadership and develops CMC regulatory strategy in support of global vaccine programs in various stages...

Company: Takeda
Location: Boston, MA
Posted Date: 22 Feb 2025

Associate Regulatory Affairs CMC Director

with approved chemistry, manufacturing and control (CMC) requirements. Provide CMC Regulatory expertise for commercial... closely with the PSC/CMC, Regulatory Affairs, and Quality Assurance departments, as well as with cross-functional project...

Company: Exelixis
Posted Date: 15 Dec 2024
Salary: $158000 - 224500 per year

AD / Sr AD, US Product CMC Regulatory Affairs (Hybrid)

applications and post marketing reports per US FDA regulations. The Associate Director, US Product CMC Regulatory Affairs acts... and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Associate Director, US Product CMC...

Posted Date: 26 Feb 2025

Associate Director/Principal Scientist, CMC Analytical Chemistry

Description Latigo is searching for an Associate Director/Princiipal Scientist, CMC Analytical Chemistry. Reporting to the Director... with cGMPs, and with CMC Regulatory Affairs to author Module 3 sections of CTD regulatory submissions and written responses...

Company: Latigo Bio
Location: Thousand Oaks, CA
Posted Date: 12 Feb 2025
Salary: $150000 - 185000 per year

Associate Director, North America Regulatory Leader

by the Company. We are searching for the best talent for Associate Director, North America Regulatory Leader... for humanity. Learn more at https://www.jnj.com Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs...

Location: Raritan, NJ
Posted Date: 08 Mar 2025

Associate Director, North America Regulatory Leader

best talent for Associate Director, North America Regulatory Leader to be in Raritan, NJ. You will be responsible for: Key... for humanity. Learn more at https://www.jnj.com Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs...

Location: Raritan, NJ
Posted Date: 07 Mar 2025

(Associate) Director/Senior Director, Regulatory Affairs, Therapeutics

OPPORTUNITY Mammoth is hiring a(n) (Associate) Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the... will be responsible for coordinating all aspects of regulatory strategy, interactions, and filings. The (Associate) Director/Sr. Director...

Location: Brisbane, CA
Posted Date: 11 Feb 2025

Director, Regulatory Affairs - Small Molecule Strategy

and approval of our innovative therapies. Responsibilities: The Associate Director of regulatory Affairs will be responsible... to join our team as an Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas. The...

Location: Boston, MA
Posted Date: 22 Jan 2025

Associate Director of IT R&D

treatment of NASH with compensated cirrhosis. Role Overview: Associate Director of IT R&D Reporting to the Executive... Director of IT R&D and Quality, as the Associate Director of IT R&D, you will play a pivotal role in managing, implementing...

Posted Date: 07 Mar 2025

Associate Director of IT Governance

treatment of NASH with compensated cirrhosis. Role Overview: Associate Director of IT Governance Reporting to the Executive... Director of IT R&D and Quality, the Associate Director of IT Governance will play a pivotal role in ensuring sustainable...

Posted Date: 07 Mar 2025

Associate Director Chemical Development

in our office three days per week on average. Associate Director, Chemical Development will be responsible for the chemical..., contribution towards CMC content for regulatory submissions, regulatory approval and product life cycle management. The role...

Posted Date: 01 Mar 2025

Associate Director, External Quality

-changing medicines? As the Associate Director, External Quality, you will be responsible for leading the Quality of assigned... for timely product deliveries. Proactively ensures GMP and regulatory compliance during the planning, execution and closeout...

Company: AstraZeneca
Location: Gaithersburg, MD
Posted Date: 01 Mar 2025
Salary: $155126 - 186150 per year

Associate Director Chemical Development

in our office three days per week on average. Associate Director, Chemical Development will be responsible for the chemical..., contribution towards CMC content for regulatory submissions, regulatory approval and product life cycle management. The role...

Posted Date: 23 Feb 2025

Associate Director, Global Program Management, Neuroscience TAU

. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director... of Sr. Manager and/or Associate Director level GPMs as well as contractors within the GPM function. May support Business...

Company: Takeda
Location: Cambridge, MA
Posted Date: 12 Feb 2025

Associate Director, Quality Assurance Vendor Management

and inspires. POSITION OVERVIEW: Disc Medicine is hiring a new Associate Director, Quality Assurance Vendor Managment due.../Contract Service Provider qualification and audit program in all areas of GxP (GMP, GCP, GVP, GLP). Reporting to the Director...

Company: Disc Medicine
Location: Massachusetts
Posted Date: 12 Feb 2025