Senior Director Regulatory Affairs
4 weeks ago
Senior Director, Regulatory Affairs
San 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 therapeutic programs, guiding them from inception to market success.
Key Responsibilities
- Establish the regulatory pathway to IND filing in complex programs using a novel gene editing technology
- Collaborate with various regulatory consultants, clinical advisory board members, and board members to maintain regulatory knowledge of US and EU
- Interface with CMC, nonclinical research and clinical research personnel and help keep them apprised of new regulations, standards, policies, and guidance issued by regulatory authorities
- Serve as a liaison between the company and regulatory agencies
Required Qualifications
- Minimum of 10+ years of experience in the biotechnology and/or biopharmaceutical industry (Master’s degree with 8+ years of experience or PhD with 6+ years of experience); Sr. Director: Minimum of 12+ years of experience in the biotechnology and/or biopharmaceutical industry (Master’s degree with 10+ years of experience or PhD with 8+ years of experience).
- Experience with US and clinical trial submissions through with CBER/OTAT or ex-US equivalent
- Experience with gene therapy products regulatory requirements
- Bachelor’s degree in life sciences
-
Regulatory Affairs Director
4 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 &...
-
Senior Director Regulatory Affairs
5 days 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...
-
Senior Director Regulatory Affairs
1 month 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...
-
Director, Regulatory Affairs
1 week 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...
-
Director, Regulatory Affairs
2 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...
-
San Francisco, United States BioLink 360 Full timeSenior Regulatory Affairs Specialist-Remote Based-West Coast Description Reports to: Global Regulatory Affairs Director Salary Range: 140-170K Location: Remote Based Travel: Occasional travel to West Coast, Must reside in Pacific or Mountain time zone This Senior Regulatory Affairs Specialist will have an opportunity to work on new to market technology that...
-
Senior Director, CMC Regulatory Affairs
4 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...
-
Senior Director, Regulatory Affairs DICE
7 days 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...
-
Regulatory Affairs Senior Program Manager
3 weeks ago
San Francisco, California, United States UCSF Full timeJob 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...
-
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...
-
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
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...
-
Regulatory Affairs Specialist
3 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 CMC Associate
2 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,...
-
Vice President, Regulatory Affairs
2 weeks 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...
-
Vice President, Regulatory Affairs
5 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...
-
Regulatory Affairs Associate
2 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...
-
San Jose, United States ESR Healthcare Full timeDirector 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...
-
Executive Director, Regulatory Affairs
1 month 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 Executive Director in Regulatory Affairs to oversee and direct the strategic planning and execution of clinical regulatory activities essential for...
-
Executive Director, Regulatory Affairs
4 weeks 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 Executive Director in Regulatory Affairs to oversee and direct the strategic planning and execution of clinical regulatory activities essential for...