Current jobs related to Director of Regulatory Affairs CMC - San Francisco - SciPro
-
Director of Regulatory Affairs CMC
2 months ago
San Francisco, United States SciPro Full timeDirector Regulatory Affairs CMCSan Francisco, CA (Hybrid)6 month initial contract (likely extension and conversion to FTE)This client is a clinical-stage precision oncology biotech focused on creating cutting-edge therapies to target cancer treatments. Responsibilities:Develop and implement CMC regulatory strategies to facilitate the clinical development and...
-
Regulatory Affairs CMC Associate
3 months 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
3 months 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 CMC Specialist
1 week ago
San Mateo, California, United States The Fountain Group Full timePosition Overview:We are seeking a qualified candidate with expertise in Pharmaceutical Regulatory CMC to join our team. While preference is given to local candidates in the Bay Area, we are open to considering individuals located within the Pacific time zone who possess relevant experience.Key Responsibilities:Prepare and manage moderately complex...
-
Executive Director, Regulatory Affairs
6 minutes ago
San Diego, United States Regulatory Affairs Professionals Society Full timeBe a part of a global team that is inspired to make a difference in the lives of people living with rare disease.At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because...
-
Regulatory Affairs Specialist
11 hours ago
San Francisco, California, United States Pharmatech Associates Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Pharmatech Associates. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the compliance of our clients' projects with global regulatory requirements.Key ResponsibilitiesCMC and Clinical Regulatory Expertise: You will...
-
Regulatory Affairs Director
4 days ago
San Diego, California, United States Codera Full timeJob DescriptionOverviewCodera, a leading life sciences-focused investment company, is seeking a highly skilled Regulatory Affairs Director to support the development and execution of domestic and international regulatory strategy.Key ResponsibilitiesRegulatory Strategy Development: Provide strategic advice and support the development and execution of...
-
Regulatory Affairs Director
5 days ago
San Diego, California, United States Codera Full timeJob DescriptionOverviewCodera, a leading life sciences-focused investment company, is seeking a highly skilled Regulatory Affairs Director to support the development and execution of domestic and international regulatory strategy.Key ResponsibilitiesRegulatory Strategy Development: Provide strategic advice and support the development and execution of...
-
Director of Regulatory Affairs
3 weeks ago
San Carlos, United States HealthCare Recruiters International Full timeOur client is a global leader in the development and commercialization of first-in-class robotic systems for the diagnosis and treatment of patients in need of advanced surgical interventions, including solid tumors. They have immediate need for a well-qualified Director of Regulatory Affairs to support an R&D team charged with developing effective small...
-
Director of Regulatory Affairs
3 weeks ago
San Carlos, United States HealthCare Recruiters International Full timeOur client is a global leader in the development and commercialization of first-in-class robotic systems for the diagnosis and treatment of patients in need of advanced surgical interventions, including solid tumors. They have immediate need for a well-qualified Director of Regulatory Affairs to support an R&D team charged with developing effective small...
-
Regulatory Affairs Specialist
4 weeks ago
San Diego, United States Katalyst HealthCares & Life Sciences Full timeJob Description Job Title: Regulatory Affairs Specialist Company: US Tech Solutions Job type: Contract Duration: 12 months ID: 5175 Department: Regulatory Affairs Prerequisites: BS/BA degree in Scientific Discipline (Masters or higher preferred) A minimum of 7 years in the pharmaceutical industry A minimum of 5 years CMC regulatory (biologics preferred)...
-
Regulatory Affairs and Compliance Lead
12 hours ago
San Diego, California, United States ORIC Pharmaceuticals, Inc. Full timeJob SummaryORIC Pharmaceuticals, Inc. is seeking a highly motivated and experienced Director/Associate Director to lead our Regulatory Affairs and Compliance team. As a key member of our organization, you will be responsible for ensuring compliance with global regulatory requirements and developing strategies to support our clinical development programs.Key...
-
Director, Regulatory Affairs
3 weeks ago
San Diego, United States Pacira Pharmaceuticals Full timeDescriptionAbout PaciraPacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Each of our 3 marketed products, both in pharmaceutical and medical device, represent cutting edge technologies for pain...
-
Director, Regulatory Affairs
1 month ago
San Diego, CA, United States Pacira Pharmaceuticals Full timeDescriptionAbout PaciraPacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Each of our 3 marketed products, both in pharmaceutical and medical device, represent cutting edge technologies for pain...
-
Senior Regulatory Affairs Consultant
1 week ago
San Diego, California, United States Katalyst HealthCares & Life Sciences Full timePosition Title: Regulatory Affairs SpecialistCompany: Katalyst HealthCares & Life SciencesEmployment Type: ContractDuration: 12 monthsDepartment: Regulatory AffairsQualifications: Bachelor’s or Master’s degree in a relevant Scientific Discipline At least 7 years of experience in the pharmaceutical sector Minimum of 5 years of experience in CMC regulatory...
-
CMC Regulatory Compliance Associate
1 week ago
San Mateo, California, United States The Fountain Group Full timePosition Overview:We are seeking a qualified candidate with expertise in Pharmaceutical Regulatory CMC to join our team. While preference is given to local candidates, we are open to considering individuals located within the Pacific time zone who possess the necessary experience.Key Responsibilities:Prepare and manage moderately complex regulatory...
-
Regulatory Affairs Specialist
4 weeks ago
San Mateo, United States Collabera Full timeThe Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls) – Data Administrator Contractor will play a key role in supporting the RA CMC team by managing product information within Gilead Information Systems. This position involves routine data entry, quality control, and report generation to ensure the completeness, correctness, and consistency...
-
Director, Regulatory Affairs
1 month ago
South San Francisco, California, United States tapwage Full timeAbout 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 TTM) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of...
-
Senior Manager, Regulatory Affairs, CMC
3 months ago
San Mateo, United States BeiGene Full time**General** **Description:** BeiGene is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent with company goals. This individual will be responsible for development of strategies, planning, drafting, and managing CMC-related regulatory submissions and HA interactions to meet the...
-
Regulatory Affairs Associate
1 month ago
San Mateo, United States Net2Source Inc. Full timeJob Title: Regulatory Affairs CMC – Data Administrator ContractorLocation: Foster City, CA 94404Duration: 12+ Months (Extendable)Pay Rate: $65.00/hr. on W2Specific Job Responsibilities:Perform data entry using Information Systems to enter and maintain relevant product information to support cross-functional stakeholders.Work collaboratively to support the...
![SciPro](https://media.trabajo.org/img/noimg.jpg)
Director of Regulatory Affairs CMC
1 month ago
Director Regulatory Affairs CMC
San Francisco, CA (Hybrid)
6 month initial contract (likely extension and conversion to FTE)
This client is a clinical-stage precision oncology biotech focused on creating cutting-edge therapies to target cancer treatments.
Responsibilities:
- Develop and implement CMC regulatory strategies to facilitate the clinical development and eventual marketing approval of investigational products
- Oversee the creation and upkeep of the PDM and quality sections for regulatory submissions, including initial IND, IMPD/CTA, NDA, MAA filings, and amendments, as well as preparing responses to inquiries from Health Authorities (HAs)
- Act as the PDM regulatory representative on project teams, offering CMC regulatory support to ensure compliance with relevant regulatory requirements during the clinical development of investigational products
- Collaborate with the corporate regulatory team, CMC subject matter experts, and/or CROs to identify regional and country-specific CMC requirements, driving PDM submission timelines to achieve business objectives
- Engage with the FDA and other global regulatory bodies as needed. Provide regulatory assessments and guidance on PDM-related change controls, deviations, and investigations throughout the product lifecycle
Requirements:
- Preferably an advanced degree (MSc or PhD) in Pharmaceutical Science, Chemistry, Chemical Engineering, or a related field is preferred
- The candidate should have over 12 years of experience in pharmaceutical/biotech drug development, including more than 4 years in global CMC regulatory affairs, with expertise in PDM development for NCEs/small molecules
- They should have a proven track record in leading global PDM-related submissions (IND, IMPD/CTA, NDA, MAA, etc.)
- A deep understanding of US and international GMP quality regulations, current industry practices, and the ability to interpret and apply these to development projects and regulatory issues for marketed products is essential.