Current jobs related to Regulatory Affairs Consultant - San Diego, California - Cullgen
-
Senior Regulatory Affairs Specialist
5 days ago
San Diego, California, United States Surf Search Full timeWe are looking for a talented Senior or Principal Regulatory Affairs Specialist to join our client's team and play a crucial role in bringing new products to market. This role will be responsible for leading the regulatory strategy and managing submissions for new product launches for our client's cardiovascular medical device portfolio.This hands-on role...
-
Director, Regulatory Affairs
6 days ago
San Diego, California, United States Insmed Incorporated Full timeAt Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful...
-
Sr Manager Regulatory Affairs
7 days ago
San Diego, California, United States DexCom Full timeThe Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting...
-
Vice President, Regulatory Affairs
2 weeks ago
San Francisco, California, United States ELKA Search Partners Full timeVice President, Regulatory AffairsWe are seeking an experienced Regulatory Affairs leader to drive global regulatory strategy and execution across rare disease programs. This role will partner closely with the executive team and cross-functional leaders to guide programs through global submissions, regulatory interactions, and approvals.Key...
-
Regulatory Affairs Specialist 3
2 weeks ago
San Diego, California, United States GRIFOLS, S.A. Full time $105,800 - $132,250table.MiTabla { max-width: 1020px;importantWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived...
-
Regulatory Affairs Director
6 days ago
San Francisco, California, United States Pano AI Full time $165,000 - $200,000Who we areThe problem: Every minute matters in fire response. As climate change amplifies the intensity of wildfires—with longer fire seasons, drier fuels, and faster winds—new ignitions spread faster and put more communities at risk. Today, most wildfires are detected by bystanders and reported via 911, meaning it can take hours to detect a fire,...
-
San Diego, California, United States Werfen Full timeOverviewJob SummaryAutoimmunity Managers are responsible for planning and managing the operations of their assigned department to ensure successful operations in compliance with Quality Systems and other Regulatory, Human Resources, and Legal requirements, as well as all company policies. Responsible for ensuring department goals are met and budgets are...
-
Director, Regulatory Affairs
2 weeks ago
South San Francisco, California, United States Zai Lab Full timeCompany Description Zai Lab is a patient-focused, innovative, commercial-stage, global biopharmaceutical company based in China and the United States. We are dedicated to discovering, developing, and commercializing best-in-class and first-in-class therapies that address medical conditions with significant unmet needs in oncology, immunology, neuroscience,...
-
Senior Regulatory Affairs Specialist
2 weeks ago
San Rafael, California, United States Tucker Parker Smith Group (TPS Group) Full timeRegulatory Affairs Manager – Clinical & Nonclinical SubmissionsLocation:Fully RemoteIndustry:Biotechnology / PharmaceuticalDuration:10 months (potential to extend or convert)Pay:$60-70/hourOur client is a leading biotechnology company known for developing breakthroughs in rare and specialty diseases. They combine cutting-edge science with a mission-driven...
-
Senior Manager, Regulatory Affairs
7 days ago
South San Francisco, California, United States Maze Therapeutics Full time $180,000 - $220,000The Position: Join Maze Therapeutics as a Senior Manager, Regulatory Affairs, where you will play a critical role in advancing our clinical-stage programs by providing regulatory expertise and executional leadership. As a key member of the development team, you will collaborate with cross-functional teams to manage and support global regulatory activities....
Regulatory Affairs Consultant
2 weeks ago
Job Summary:
We're looking for a Regulatory Affairs Consultant to join us and help drive and support our growing regulatory function. You will work collaboratively with other functional leaders across the organization, as well as external stakeholders. Our ideal candidate will have experience leading the regulatory function in different therapeutics areas and includes both tactical and strategic responsibilities.
Responsibilities:
- Work with the team to compile submissions of original IND and responses to all regulatory authority queries.
- Plan, oversee and participate in all regulatory activities, including regulatory submissions (INDs, NDAs, MAAs, CTAs etc.), internal preparation and agency meetings.
- Serve as a company contact with the FDA and other regulatory authorities.
- Ensure all external data complies with required specifications, standards, protocols, SOPs and overall clinical objectives.
- Enable creative solutions to regulatory challenges to timely advance therapeutics to meet key development milestones including positioning for successful pivotal trials and registration.
Requirements:
- 15+ years of industry experience in running global clinical regulatory operations and related activities in addition to successful track record as a regulatory consultant required.
- D., PharmD or other relevant post-graduate level training strongly preferred.
- Excellent working knowledge of regulatory regulations, guidelines, and all phases of clinical drug development.
- Experience with Type D meetings and responses needed.
- Ability to lead and advise under pressure, respond to complex operational challenges with innovative solutions supported by appropriate tactics.
- Ability to occasionally work onsite from our San Diego offices.
This is part time consulting role, and expected to be 10 hours/week. Local candidates highly preferred.
