Regulatory Affairs Manager

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...

Job DescriptionJob DescriptionThe 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...

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 &...

Job Description Key Responsibilities   Responsible for providing regulatory strategy & support for global development. Responsible for supporting teams & efforts around major filing activities & Regulatory Health Authority (RHA) interactions & meetings, attending & providing regulatory support to other departments, project teams & committees. Organize...

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...

Job SummaryThe Living Therapeutics Initiative seeks a highly motivated Regulatory Affairs Senior Manager to manage the regulatory affairs, author and assemble IND applications, and help manage FIH studies advancing UCSF-developed cellular therapy candidates. The successful candidate will work in a dynamic academic environment, working across various...

Job DescriptionJob DescriptionSalary: $90KPurpose:The Regulatory Affairs Manager is responsible for managing the regulatory affairs department and functions to ensure regulatory compliance of quality management system.Duties & Responsibilities: Review and approve audit agenda, plan, summary reports for internal audits. Facilitate and participate in external...

Responsibilities: Provides administrative support for regulatory affairs manager Provides RA support for change control projects and sustaining activities Conducts regulatory assessments and determines need for re-registration for proposed device changes, prepares internal documentation for changes not requiring re-registration (FDA, EU, OUS) ...

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...

Job DescriptionJob DescriptionSalary: $90KPurpose:The Regulatory Affairs Manager is responsible for managing the regulatory affairs for the product development department and functions to ensure regulatory compliance of quality management system, product realization and marketing materials.   Duties & Responsibilities: Directly support the product...

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,...

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...

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...

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...

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...

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: Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference EU Member States Manage execution / authoring and review of CMC documentation (Module 1 , 2 and 3 / Part II ) for life cycle management - post-approval supplements, baseline dossiers, annual reports,...

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...