Regulatory Affairs CMC
3 weeks ago
Job Description:
Title: Regulatory Affairs CMC
Location: Foster City, CA
Specific Job Responsibilities:
- Participates in preparing moderately complex CMC regulatory submissions under direction of a senior Regulatory Affairs professional which require some interactions with other members in the Regulatory CMC department and technical teams as well as senior stakeholders for investigational and commercial products in line with US and ICH requirements, regional requirements and scientific and company policies and procedures.
- Works to develop and acquire required regulatory skills and basic CMC knowledge, with guidance from immediate supervisor.
- Assist with miscellaneous US RA CMC team-related administrative documentation/tracking and product maintenance activities. Performs workflows and procedures regarding document tracking, indexing, and retrieving, and disseminating information to the Regulatory Affairs CMC department.
- Participates in group meetings and provides tactical approaches to addressing issues of moderate complexity and seeks assistance from appropriate internal and external resources.
- Work cross-functionally within a matrixed organization.
- Must work well under deadlines and have excellent attention to detail in alignment with project goals and regulatory submission timelines.
- Strong computer and organizational skills required.
- Excellent verbal and written communication skills and interpersonal skills are required.
Education & Experience:
- A Bachelors Degree with a minimum of 2+ years of relevant training or industry experience preferably in a GMP environment, OR 1+ years relevant training and industry experience preferably in GMP environment with advanced degree.
by Jobble
-
Regulatory Affairs CMC Associate
3 weeks ago
San Mateo, United States Fladger Assoc. Inc. Full timeJob 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,...
-
Regulatory Affairs CMC Associate
7 days ago
San Mateo, United States Fladger Assoc. Inc. Full timeJob 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,...
-
Regulatory Affairs CMC Associate
24 hours ago
San Mateo, United States The Fountain Group Full timeOverview: 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...
-
Regulatory Affairs Associate
3 weeks ago
San Mateo, United States Fladger Assoc. Inc. Full timeJob 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...
-
Regulatory Affairs Associate
7 days ago
San Mateo, United States Fladger Assoc. Inc. Full timeJob 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...
-
Senior Director, CMC Regulatory Affairs
3 weeks ago
South San Francisco, United States Allogene Therapeutics Full timeJob 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...
-
Sr. Dir/Director of Regulatory CMC
2 weeks ago
San Diego, United States BioPhase Full timeRemote - Candidates must be located in the United States - Ideally Southern California The Sr. Director/Director of CMC Regulatory Affairs will be responsible for developing, leading and executing CMC regulatory strategies and activities for the organization, including the preparation and filing of BLA submissions. This position is a hands-on role, providing...
-
Senior Director Regulatory Affairs
4 weeks ago
San Francisco, United States SciPro Full timeSenior 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...
-
Vice President, Regulatory Affairs
4 days ago
San Diego, United States Device Search Group Defunct Full timeWe 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...
-
Vice President, Regulatory Affairs
6 days ago
San Diego, United States Device Search Group Full timeWe 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...
-
Senior Director, Regulatory Affairs DICE
1 hour ago
San Francisco, United States Advance Global Professionals Inc. Full timeBe 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...
-
Director Biologics API Chemical Development CMC
2 weeks ago
San Diego, United States Clinical Dynamix, Inc. Full timeAbout the Role:Seeking a highly motivated and talented biologics leader within CMC (antibodies, gene therapy) in the areas of upstream and downstream API development, optimization and manufacture. The successful candidate will work on research and development of biologics processes and regulatory document contribution internally and will also perform and...
-
Regulatory Affairs Director
3 weeks ago
San Francisco, United States BioLink 360 Full timeCompany 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 &...
-
Regulatory Affairs Specialist
3 days ago
San Diego, United States Genalyte Full timeHere at Genalyte, you will find yourself working with talented individuals inspired by our vision, eager to make an impact on the patient experience, and who share a common goal of getting our technology into every physician’s office. We have a great opportunity for a Regulatory Affairs Specialist to join our team! **ABOUT THE ROLE** The Regulatory...
-
Regulatory Affairs Specialist
2 weeks ago
San Francisco, California, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: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
4 days ago
San Diego, United States Cypress Human Capital Management, LLC Full timeRegulatory 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...
-
Principal Regulatory Specialist
1 week ago
San Mateo, United States Presidio Medical, Inc. Full timeJob 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...
-
Director of Regulatory Affairs
4 weeks ago
San Antonio, United States Evestra, Inc. Full timeOur 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...
-
Director of Regulatory Affairs
3 weeks ago
San Antonio, United States Evestra, Inc. Full timeOur 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...
-
Director, Regulatory Affairs
3 days ago
South San Francisco, United States Maze Therapeutics Full timeThe 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...