Regulatory Affairs CMC

Job DescriptionJob DescriptionFoster City, CAContract Duration: 6-18 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area candidates ONLYProvide Regulatory CMC support for biologic and small molecule drugs being evaluated or marketed for the treatment of oncology,...

Overview: Prefers the candidate to be local in the Bay Area BUT will consider qualified candidates with Pharma Regulatory CMC experience in the Pacific time zone ONLY. Responsibilities Responsible for the preparation of moderately complex regulatory submissions which require interaction with departments outside of Regulatory Affairs CMC for investigational...

Job DescriptionJob DescriptionFoster City, CAContract Duration: 12-18 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Regulatory Affairs Associate II in the Foster City, CA area. (Onsite Role)Contractor must meet the company site requirements for the COVID Vaccination PRIOR to starting roleResponsible for the preparation of Drug...

Job Description About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is...

Senior Director, Regulatory AffairsSan Francisco, CA (Hybrid)Join this Bioscience company on the forefront of groundbreaking therapeutics! I'm supporting a company seeking a dynamic individual for the role of Sr. Director, Regulatory Affairs. This pivotal position offers the opportunity to spearhead regulatory strategies for our expanding CRISPR-based...

Senior Director, Regulatory AffairsSan Francisco, CA (Hybrid)Join this Bioscience company on the forefront of groundbreaking therapeutics! I'm supporting a company seeking a dynamic individual for the role of Sr. Director, Regulatory Affairs. This pivotal position offers the opportunity to spearhead regulatory strategies for our expanding CRISPR-based...

Director of Regulatory Affairs San Jose, CA REF DESCRIPTION The position is independently responsible for development of global regulatory strategy and representation of Regulatory Affairs on R&D project teams. You will be responsible for managing all Regulatory Affairs activities (nonclinical and clinical) for investigational drug-device combination...

We are seeking an experienced Senior Director or Vice President of Regulatory Affairs (DOE). As the head of Regulatory Affairs you will be responsible for leading and managing all aspects of Clinical and CMC Regulatory Affairs. The ideal candidate will have a strong background in cell therapy with experience in early development regulatory affairs (pre-IND...

We are seeking an experienced Senior Director or Vice President of Regulatory Affairs (DOE). As the head of Regulatory Affairs you will be responsible for leading and managing all aspects of Clinical and CMC Regulatory Affairs. The ideal candidate will have a strong background in cell therapy with experience in early development regulatory affairs (pre-IND...

Be accountable for leading the development of strategic plans for pipeline assets and implementation. Provides leadership on project teams in all areas of regulatory affairs Develop regulatory strategies across multiple regulatory activities (CMC, nonclinical, and clinical) to ensure timelines and achievements are met to support the business needs of the...

Company OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...

Company Location: Bay Area Comp: 150K-220K Position Reports to: VP of Regulatory and Quality Director of Regulatory Affairs -San Francisco We are seeking a highly motivated and experienced Senior Director of Regulatory Affairs for a Medical Device Orthopedic Portfolio. This person will lead interactions with regulatory agencies globally and help develop &...

Director of CMC Location : San Francisco, CA Working situation : Hybrid Level : Director Our client, a blooming biotechnology company, is looking to expand their R&D capacity to support their growing pipeline including a new class of brain therapies. With a passion for treating neurodegenerative and neuropsychiatric disorders, they are at the forefront of...

US Regulatory Affairs Lead-------------------------------------------------------------------------------------------------SCOPE OF RESPONSIBILITIES:' He/She will be responsible for representing regulatory function to approve promotional material' He/She will be at ease working in a matrix environment and be able to navigate ambiguity to drive decision...

US Regulatory Affairs Lead ------------------------------------------------------------------------------------------------- SCOPE OF RESPONSIBILITIES: " He/She will be responsible for representing regulatory function to approve promotional material " He/She will be at ease working in a matrix environment and be able to navigate ambiguity to drive decision...

Responsibilities:Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products\' registration.Participate on product development teams, providing regulatory strategies, timelines, and direction. Reviews and approves technical...

Regulatory Affairs Specialist The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clinical study trials, including offsite location for trials when needed. Essential...

Job Summary: The Principal Regulatory Affairs (RA) Specialist will work with the team to support the Regulatory Affairs department to ensure the overall regulatory compliance with the applicable regulatory bodies and ensure compliance with the Presidio Quality Management System (QMS). The Principal Regulatory Affairs Specialist is responsible for...

The Position: Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you will...

Our Company:Evestra, Inc. is an emerging biopharmaceutical company that focuses on developing and commercializing women’s healthcare products. Based in San Antonio, Texas, Evestra’s mission is to improve the health and well-being of women around the world through innovative technologies and products. Responsibilities:Develop and oversee regulatory...