- Provide expert, technical and professional advice, guidance and leadership to the Company on Regulatory Affairs matters.
- Proactively participate in design of global regulatory strategies for the development of cell therapy products
- Serve as one of the primary liaison between Turnstone and all strategic partners/ partner companies in regulatory topics/issues.
- Plan, oversee and manage preparation and submissions (including but not limited to pre-IND, Initial IND/CTA and amendments, Safety reporting, BLA, Orphan drug designation); this will require strong regulatory knowledge and understanding of the underlying science, cross-functional interactions, and excellent project management and writing skills
- Participate in interactions with regulatory agencies to solidify strategy and address regulatory comments
- Lead preparation of agency meetings and actively participate in scheduled meetings
- Drive adherence to regulatory requirements and guidelines
- Perform regulatory intelligence activities - monitor regulation changes and competitor trends/strategy
- Provide regulatory input regarding budget
- With Clinical Operations and Quality Assurance, ensure compliance of Clinical Development with GCPs and SOPs and other relevant regulations.
- Review and approve departmental and Clinical SOPs and revisions.
- Manage all relevant contract relationships.
- Maintain a thorough understanding of GCPs, internal SOPs, and guidance documents issued by various regulatory agencies, including the US-FDA, EMA, and ICH.
- Maintain a regulatory document system.
- Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience
- Regulatory Affairs Certification (RAC) preferred
- Background ideally oncology cell therapy or biologics
- 8 + year experience with PhD; 10+ years with Masters or bachelor's degrees
- Proven track record of managing critical projects as a part of an interdisciplinary team
- Proven track record of representing the department in project teams, committees and external meetings
- Prior experience managing regulatory submissions to deadlines
- Thorough understanding of relevant drug development regulations and guidelines
- Outstanding interpersonal and communication (written and verbal) skills
- Effective task planning and coordination abilities
- Proficiency with computer and standard software programs (Microsoft Office, PowerPoint and Excel)
-
Regulatory Leader
3 days ago
VALID8 Financial San Diego, United StatesTurnstone Biologics is a clinical-stage biotechnology company developing new medicines to treat and cure solid tumors by pioneering a differentiated approach to TIL therapy. Turnstone's innovative TIL therapy is based upon the identification, selection, and expansion of the most ...
-
Regulatory Leader
3 days ago
VALID8 Financial San Diego, United StatesTurnstone Biologics is a clinical-stage biotechnology company developing new medicines to treat and cure solid tumors by pioneering a differentiated approach to TIL therapy. Turnstone's innovative TIL therapy is based upon the identification, selection, and expansion of the most ...
-
Regulatory Leader
1 day ago
VALID8 Financial San Diego, United StatesTurnstone Biologics is a clinical-stage biotechnology company developing new medicines to treat and cure solid tumors by pioneering a differentiated approach to TIL therapy. Turnstones innovative TIL therapy is based upon the identification, selection, and expansion of the most p ...
-
Vp, Us Acute Care Infusion
2 days ago
BD San Diego, United States**Job Description Summary**: · **We are **the makers of possible**: · BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and ...
-
Director, Ds Clinical Programs
4 days ago
Rady Children's Hospital-San Diego San Diego, United StatesProvide leadership in clinical program development, implementation and evaluation. · Ensure compliance with regulatory standards and best practices in the industry. · Collaborate with other healthcare professionals to ensure quality care for patients. · Oversee budgeting, resourc ...
-
Insourced Solutions for Tax
4 days ago
PRICE WATERHOUSE COOPERS San Diego, United StatesTo really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be a purpose-led and values-driven leader at every level. To help us achieve this we have the PwC Professional; our global leadership development framework. ...
-
Head of Clinical Operations
2 days ago
Candid Therapeutics San Diego, United States**Company Overview**: · Candid Therapeutics is a growing biotechnology company based in San Diego, California, dedicated to improving patients' lives by advancing novel therapies to address unmet medical needs. · **Position Overview**: · As the Head of Clinical Operations, you wi ...
-
Water Resources Director
3 days ago
NV5 San Diego, United StatesOverview: · **Responsibilities**: · **Responsibilities**: · - Develop and maintain a sustainable sales pipeline. · - Identify and lead new significant client pursuits in Southern California. · - Originate $1M+ in sales revenue annually. · - Management of key accounts (>$350K/year ...
-
Site Leader/plant Manager
5 days ago
Ryzen Solution San Diego, United States**Site Leader** · Position Summary: · The Site Leader must be organized and able to supervise all manufacturing processes at our plant. He/She is responsible for ensuring that deadlines are met while following health and safety protocols. To be successful as a Site Leader you mus ...
-
Bristol-Myers Squibb San Diego, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
-
Controller/director of Finance
3 days ago
Maritime Institute San Diego, United States**Controller** · **Organization Name**: Training Resources Limited, DBA Maritime Institute · **FLSA Status**: Exempt · **Prepared Date**: · **Hiring Manager Job Title**: CEO · **Job Level: Manager/Director** · **Employment Status**: Full-time Regular · **Primary Location**: San ...
-
Head of Program Management
2 days ago
Candid Therapeutics San Diego, United States**Company Overview**: · Candid Therapeutics is a growing biotechnology company based in San Diego, California, dedicated to improving patients' lives by advancing novel therapies to address unmet medical needs. · **Position Overview**: · As the Head of Program Management, you wil ...
-
Associate Banker
5 days ago
BMO US San Diego, United States701 B St. San Diego California,92101 · **This is a part-time 20 hours a week position.** · Delivers exceptional service to BMO customers and prospects. Identifies customer needs and provides advice and guidance regarding financial solutions that are in the best interests of custo ...
-
Registered Nurse
4 days ago
Fresenius Medical Care San Diego, United States Full timePOSITION FEATURES: · $10,000 Sign on Bonus · Paid one on one training and education provided. · Employer, engage and train dialysis patients on peritoneal and home hemodialysis using state of the are training programs and equipment. · Primarily works in the clinic setting and con ...
-
Quality Specialist
4 days ago
Actalent San Diego, United States Full timeDescription: · • Perform product lot disposition by reviewing executed packaging records for completeness, accuracy, and compliance to GMP and company procedures. · • Perform document change control activities as needed. · • Perform and lead in investigations, NCMRs and Complaint ...
-
Quality Specialist
4 days ago
Actalent San Diego, United States Full timeDescription: · • Perform product lot disposition by reviewing executed packaging records for completeness, accuracy, and compliance to GMP and company procedures. · • Perform document change control activities as needed. · • Perform and lead in investigations, NCMRs and Complaint ...
-
Director, Health System Funds Flow
3 days ago
UC San Diego Health San Diego, United StatesPayroll Title: · - EXEC ADVISOR 4 · - Department: · - FINANCIAL ADMINISTRATION · - Hiring Pay Scale · - $155,000 - $200,000 / Year · - Worksite: · - Greenwich Drive · - Appointment Type: · - Career · - Appointment Percent: · - 100% · - Union: · - Uncovered · - Total Openings: · - ...
-
Federal Business Development, Vice President
3 days ago
BD San Diego, United States**Job Description Summary**: · We are **the makers of possible** · BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and en ...
-
Quality Specialist
4 days ago
Actalent San Diego, United States Full timeDescription: · • Perform product lot disposition by reviewing executed packaging records for completeness, accuracy, and compliance to GMP and company procedures. · • Perform document change control activities as needed. · • Perform and lead in investigations, NCMRs and Complaint ...
-
Clinical Applications Specialist
3 days ago
LENSAR, Inc. San Diego, United States*LENSAR currently has one Clinical Applications Specialist opportunity available that's posted in different cities within the Western region.*_ · **Company Overview** · - LENSAR, Inc. is the leader in advanced femtosecond laser technology for refractive cataract surgery. The LENS ...
Regulatory Leader - San Diego, United States - Turnstone Biologics Corp.
Description
Turnstone Biologics is a clinical-stage biotechnology company developing new medicines to treat and cure solid tumors by pioneering a differentiated approach to TIL therapy. Turnstone's innovative TIL therapy is based upon the identification, selection, and expansion of the most potent tumor-reactive T cells, known as Selected TILs, and is designed to overcome the limitations of first-generation bulk TILs that have demonstrated objective responses only in limited tumor types. Turnstone's most advanced program, TIDAL-01, is currently being evaluated in two Phase 1 studies in patients with melanoma, breast cancer and colorectal cancer, and the Company is also actively advancing its preclinical pipeline programs including TIDAL-02, its next Selected TIL program, and its TIDAL-01 and viral immunotherapy combination program.
At Turnstone, the science drives decision-making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal - actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call 'another day at Turnstone'? If you are a passionate person, and our science excites you - this opportunity may be for you.
Position Overview
We are seeking an innovative, highly motivated, versatile leader to join us as our Clinical Regulatory Leader. This role will report to the Vice President, Clinical Development and sit will be the regulatory representative at various core teams. The successful candidate will be results-driven and a highly skilled Clinical Regulatory Leader with extensive experience in guiding regulatory strategies and ensuring compliance for pharmaceutical and biotechnology companies. The ideal candidate will be adept at navigating the complex landscape of regulatory affairs, and have a proven track record of successfully leading cross-functional teams to achieve regulatory milestones and approvals.
This is both a strategic and execution focused role requiring someone to see the big picture, plan, and roll up their sleeves and get things done. This role requires proven leadership to effectively communicate, coordinate, and collaborate cross-functionally with Clinical Operations, External Manufacturing, Quality, Technical Operations, Research, Finance, IT and Commercial teams.
KEY RESPONSIBILITIES
An attractive compensation package commensurate with this senior leadership role will be provided.
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
