Regulatory Affairs Associate
3 weeks ago
Responsibilities:
- 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 role
- Responsible for the preparation of Drug Listings/Lot Distribution Reports (Biologics)
- Responsible for compiling documentation and sending Certificate of Pharmaceutical Product (CPP) requests to FDA
- Manage Notarizations (CA licensed notary public a plus), Legalization/apostille of regulatory documents
- Assist in documentation and signature preparation for:
- License renewals
- Establishment registration
- Performs document filing and retrieval functions as directed, or in conjunction with departmental SOPs and work instructions and direction of a senior Regulatory Affairs professional.
- Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory Affairs CMC department.
- Seeks assistance from appropriate internal and external resources.
- Participates in preparing regulatory submissions under direction of a senior Regulatory Affairs Professional which require some interactions with other members in the Regulatory department 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 knowledge, with guidance from immediate supervisor.
- Assist with miscellaneous US RA CMC team-related administrative documents/activities such as processing of invoices.
- Participates in group meetings and provides tactical approaches to addressing issues of moderate complexity and seeks assistance from appropriate internal and external resources.
Experience:
- A Bachelor's Degree with a minimum of 2+ years of relevant training or industry experience preferably in a GMP environment, OR 1+ years relevant training or industry experience preferably in GMP environment with advanced degree.
- Must work well under deadlines and have excellent attention to detail.
- Strong computer and organizational skills required.
- Excellent verbal and written communication skills and interpersonal skills are required.
- Preferred:
- Degree in a relevant Scientific field
- Relevant Regulatory CMC submission experience
-
Regulatory Affairs CMC Associate
6 hours ago
San Mateo, United States Fladger Assoc. Inc. Full timeJob Description Job Description Foster City, CA Contract Duration: 6-18 months Rate: Negotiable Responsibilities: Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area candidates ONLY Provide Regulatory CMC support for biologic and small molecule drugs being evaluated or marketed for the treatment of...
-
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
2 weeks 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...
-
Intern - Regulatory Affairs
2 days ago
San Mateo, United States Mirum Pharmaceuticals Full timeMISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we're focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies...
-
San Mateo, United States Gilead Sciences Full timeEnsuring the projects they are responsible for have a cohesive regulatory strategy that is integrated into Pharmaceutical Development & Manufacturing (PDM) Project teams. The role will report directly to Head of CMC Regulatory Affairs Small Molecul Regulatory Affairs, Director, Regulatory, Leadership, Product Development, Business Services, Strategy
-
Regulatory Affairs Director
1 month 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 Manager
4 weeks ago
San Antonio, United States Extremity Care Full timeJob 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...
-
Regulatory Affairs Specialist
1 week ago
San Diego, United States Aequor Technologies Full timeUS 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...
-
Director, Regulatory Affairs
2 weeks 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...
-
Regulatory Affairs Specialist
4 days ago
San Diego, United States Aequor Technologies Full timeUS 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...
-
Associate Director Regulatory Affairs
5 days ago
San Diego, United States Partnology Full timeAn exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Associate Director in Regulatory Affairs to oversee and contribute to the strategic planning and execution of clinical regulatory activities essential for...
-
Associate Director Regulatory Affairs
1 week ago
San Diego, United States Partnology Full timeAn exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Associate Director in Regulatory Affairs to oversee and contribute to the strategic planning and execution of clinical regulatory activities essential for...
-
Associate Director Regulatory Affairs
1 week ago
San Diego, United States Partnology Full timeAn exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Associate Director in Regulatory Affairs to oversee and contribute to the strategic planning and execution of clinical regulatory activities essential for...
-
Associate Director Regulatory Affairs
4 days ago
San Diego, United States Partnology Full timeAn exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Associate Director in Regulatory Affairs to oversee and contribute to the strategic planning and execution of clinical regulatory activities essential for...
-
Associate Director Regulatory Affairs
1 week ago
San Diego, United States Partnology Full timeAn exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Associate Director in Regulatory Affairs to oversee and contribute to the strategic planning and execution of clinical regulatory activities essential for...
-
Director, Regulatory Affairs
3 weeks ago
South San Francisco, United States Maze Therapeutics Full timeJob 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...
-
Regulatory Affairs Analyst
2 days ago
San Jose, United States San Jose Water Company Full timeJob Title Regulatory Affairs Analyst | Requisition ID req607 Type of Employment Regular Full-Time Employee | Job Openings 1 Compensation Range - style="text-align:left;"> | Compensation Type Annual Salary Founded in 1866, San Jose Water Company is an investor owned water company headquartered in Silicon Valley. With a service...
-
Regulatory Affairs Specialist
3 weeks 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...
-
Regulatory Affairs Specialist
7 hours ago
San Diego, United States Eastridge InfoTech Full timeEastridge Workforce Solutions is hiring a Regulatory Affairs Specialist for a c ompany that offers cloud-based laboratory testing of blood tests through a central lab before releasing them to physicians for review and discussion with their patients, as well as providing consulting services. For immediate consideration, apply today. About The Role The...
-
Director of Regulatory Affairs
1 month 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...