- Alga Biosciences (San Francisco, CA)
- [Full Time] Governmental and Regulatory Affairs Lead at Alga Biosciences (United States)Governmental and Regulatory Affairs LeadAlga Biosciences, ... bold, game-changing climate technology? We would love to hear from you.The JobOur Regulatory Affairs Lead will develop and own our end-to-end regulatory … more
- Orca Bio (Menlo Park, CA)
- …and immune systems with healthy ones, but also restore their lives.The (Sr.) VP/Head of Regulatory Affairs will lead the company's regulatory strategy ... regulatory agencies to ensure alignment and timely feedback.Build, mentor, and lead the Regulatory Affairs team, ensuring team members are prepared to… more
- Tango Therapeutics (Boston, MA)
- …. Reporting to the President, R&D, the VP, Regulatory Affairs will lead Regulatory Affairs for Tango Therapeutics, and will drive the development of ... relevant biopharmaceutical industry experience, with at least 10 years' experience in Regulatory Affairs and deep experience in oncology; precision medicine… more
- Adverum Biotechnologies (Redwood City, CA)
- The Director/Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum's gene therapy program/s. This individual will be the key ... regulatory , and registration strategies. What you'll do:Manage the Regulatory Affairs (CMC) Strategy for Regulatory...regulatory success in a timely mannerFunction as the regulatory CMC Lead , working with other … more
- Arcellx (Redwood City, CA)
- …views and backgrounds. How You'll Make a Difference As our Senior Director, Clinical Regulatory Affairs , you'll lead and drive Arcellx's clinical ... sciences (biology, pharmaceutical sciences, or equivalent). 12-15+ years of clinical regulatory affairs experience, including early and late phase research,… more
- Jacobs Management Group (Boston, MA)
- …by leading the regulatory efforts for cutting-edge therapies.Why You Should Apply: Lead regulatory affairs for groundbreaking stem cell therapies in ... insights to the executive team.Leadership and Mentorship: Build and lead a high-performing regulatory affairs team, providing mentorship and fostering a… more
- Ironwood Pharmaceuticals (Boston, MA)
- …the burden of GI diseases and address significant unmet needs. Position Summary: Lead the Regulatory Affairs CMC function supporting process development ... to gain alignment on requirements and advance filings. Major Responsibilities: Lead the Regulatory Affairs -CMC function and set the long-term regulatory… more
- Terns Pharmaceuticals, Inc. (Foster City, CA)
- …preclinical GIPR modulator program.Who We Are Looking ForThe Vice President, Regulatory Affairs and Quality Assurance, will lead the regulatory and ... Vice President, Regulatory Affairs and Quality AssuranceTerns Pharmaceuticals,...regulatory and quality efforts and corporate goals.Manage and lead the regulatory and quality teams, ensuring… more
- Merck & Co. (Rahway, NJ)
- …Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This includes ... in GRACS for business process management and continuous improvement.-Establish and lead assigned domain Global Process Control Boards (GPCBs), accountable for… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with Legal, Commercial, Clinical, Regulatory , and Public and Government Affairs , to lead cross-functional projects as needed. Support the US ... Director, Medical Affairs Strategy - HIV Prevention Locations: United States...and relay feedback from the field to the Strategy Lead to incorporate into future strategic plans. Capture insights… more
- Dennis Partners (Boston, MA)
- …trials, now is an exciting time to join this growing organization!Responsibilities:Build and lead the Regulatory Affairs function to ensure adherence to ... They are seeking a Vice President (or SVP) of Regulatory & Quality to build and lead ...used to support the clinical development programs.Build a strong Regulatory Affairs and Quality team to meet… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides ... regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Merck & Co. (North Wales, PA)
- …to anticipate necessary changes to any aspect of assigned process and lead integration of SOP owner activities to ensure a compliant end-to-end process.Evaluate ... and lead continuous process evaluation/optimization, metric development, collection and monitoring...collaboration with the CSRM physician.Manage and prepare strategies for regulatory documents and responses to safety inquiries from healthcare… more
- Mannkind Corporation (Boston, MA)
- …advertising and promotional materials Lead , develop, mentor and manage the Regulatory Affairs team Develop and advance the organization's policy and ... Position: Executive Director/Vice President, Head of Regulatory Affairs Location: Boston, MA Job Id: 11071 # of Openings: 1 At MannKind our employees are our… more
- MannKind Corp (Boston, MA)
- …advertising, and promotional materials. Lead , develop, mentor, and manage the Regulatory Affairs team.Develop and advance the organization's policy and ... Corporation is currently seeking an Executive Director/Vice President, Head of Regulatory Affairs . Reporting to MannKind's Chief Medical Officer, this… more
- CLevelCrossing (San Francisco, CA)
- Reporting initially to the Chief Development Officer, the VP of Regulatory Affairs will support the company mission by overseeing the following functions ... of a Chief Medical Officer): Profile The VP of Regulatory Affairs will support the company mission...annual updates. Develop budgets and resource forecasts for the Regulatory Team. Lead the Regulatory … more
- ACIP (MA)
- SENIOR VICE PRESIDENT OR VICE PRESIDENT, GLOBAL REGULATORY AFFAIRS Nanobiotix - a brief historyEst. 2003, Nanobiotix is a clinical-stage biotechnology company ... development projects to staff, both direct and in-direct, and interface with key stakeholders Lead regulatory risk assessment and mitigation Lead the … more
- AstraZeneca (Boston, MA)
- Do you have expertise in, and passion for, Regulatory Affairs ? Would you like to apply your expertise and channel the scientific capabilities in a company that ... our regulatory functions through the recruitment of Regulatory Affairs Strategists (at Director and Senior...This individual will, with a high sense of urgency, lead cross- Regulatory teams and be accountable to… more
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