Senior Director/ Executive Director, Regulatory Affairs
Senior Director/ Executive Director, Regulatory Affairs
Posted on :
13-09-2025
Employer Active
1 Vacancy
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Monthly Salary
$ 255000 - 315000
Vacancy
1 Vacancy
Posted on :
13-09-2025
Job Description
Fate Therapeutics is looking for an Executive Director or Senior Director in Regulatory Affairs to oversee and direct the strategic planning and execution of clinical regulatory activities essential for initiating and conducting clinical trials and securing regulatory approvals. This role involves extensive interaction with regulatory agencies such as the FDA and EMA and provides cross-functional leadership for global filings. The ideal candidate will have extensive experience leading regulatory teams and a successful record of approved regulatory submissions. This is a full-time exempt position located at our corporate headquarters in San Diego CA.
Responsibilities
- Lead the Regulatory Affairs team in effectively working with internal and external stakeholders to independently manage clinical regulatory activities.
- Set strategy direct plan and implement clinical regulatory activities required to initiate and conduct clinical trials and to seek marketing authorization.
- Provide strong cross-functional leadership for global filings including authoring/reviewing sections of IND/CTA NDA/BLA/MAA and other global submission documents in support of clinical trials and marketing applications as well as their amendments in conformance with local regulatory requirements.
- Lead regulatory strategy and activities for pivotal and registrational studies.
- Develop and implement cross-functional department policies processes work instructions and standard operating procedures.
- Provide regulatory leadership for due diligence activities partnering activities and product/company integrations.
- Provide mentorship and oversight of Regulatory Affairs staff to plan manage author coordinate and review regulatory submission documents and development activities to support regulatory filings and dossier lifecycle.
- Work with the clinical team to provide regulatory input on clinical study protocols ICFs SAPs and CSRs.
- Apply regulations and Health Authority guidance to provide regulatory strategic leadership to cross-functional stakeholders including clinical development clinical operations and patient safety.
- Serve as a Regulatory Affairs representative in cross-functional meetings and interact with external collaborators.
- Establish functional processes guidelines and SOPs.
- Create the strategy and lead preparation of health authority meeting materials and responses to requests for information.
- Lead preparations of ex-US filings and health authority interactions.
- Serve as primary contact with regulatory authorities.
- Develop and implement departmental strategies policies and regulatory risk management.
- Assure compliance with all applicable domestic and international regulations.
- May oversee direct reports contractors and/or vendors.
- Inspire influence and motivate team members foster open communication set clear goals delegate tasks and monitor performance.
Qualifications
- BS/MS/PhD degree in a life science with at least 12 years of progressive experience in Regulatory Affairs in the biotechnology or pharmaceutical industry.
- Demonstrated direct experience with Health Authority submissions and strong knowledge of FDA/EMA/MHRA regulations and agency submission and approval processes.
- Proven experience in applying regulatory knowledge to various clinical activities; strong knowledge of clinical study design Good Clinical Practice principles and navigation of clinical development pathways.
- Strong knowledge of the regulatory requirements for a variety of clinical regulatory documents (protocols ICFs CSRs etc.).
- In-depth knowledge of various clinical areas (clinical development clinical operations safety etc.)
- Strong ability to quickly absorb new technical and strategic information and have the flexibility to adapt accordingly.
- Excellent operational skills including planning organizing and the ability to deal effectively with a variety of personnel both internally and outside the company to drive projects to timely completion.
- Excellent writing communication and interpretive skills.
- High attention to detail ability to work on multiple projects with tight deadlines and able to work independently.
- Experience leading regulatory activities for pivotal / registrational studies is highly preferred.
- Previous cell therapy product experience and regulatory knowledge is highly preferred.
- Prior direct interactions with Health Authorities are desirable.
- Prior participation in a GCP inspection is desirable.
- Experience with CTA filing preferred.
- Experience leading and managing regulatory affairs teams.
Working conditions & physical requirements
- Travel may be required.
- Subject to extended periods of sitting and standing vision to monitor and moderate noise levels.
Compensation
- The salary offer will be based on a variety of factors including level experience qualifications internal equity and location.
- Fate offers a competitive employment package that includes an annual bonus equity and a generous benefits package.
- The anticipated salary range for this role is $255000 - $315000.
The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.
Equal Employment Opportunity
Fate Therapeutics Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.
Privacy Notice
To learn about how Fate collects and uses job application information please visit Fates online Privacy Notice.
AboutFate Therapeutics Inc.
Fate Therapeuticsis a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases. Using its proprietary iPSC product platform the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf iPSC-derived cell products. The Companys effector cell pipeline includes multiplexed-engineered iPSC-derived natural killer (NK) cell and T-cell product candidates which incorporate novel synthetic controls of cell function such as chimeric antigen receptors (CARs) to target tumor-associated antigens and are intended to deliver multiple mechanisms of therapeutic importance to patients including in combination with well-established cancer Therapeuticsis headquartered inSan Diego more information please visit.
Recruitment Fraud Alert
Recently we have been made aware of unauthorized individuals falsely presenting themselves as Fate Therapeutics employees or recruiters as part of online scams or phishing attempts. Impersonators may use the Fate Therapeutics name and logo as well as employee names and job titles to gain a job seekers personal or banking information or to request payment as a condition of being considered for a position at the company. Fate Therapeutics and its employees are not involved in these scams.
Here are a few things to be aware of to help identify recruitment fraud:
- Our Talent Acquisition team only corresponds from our @ domain.
- At no stage in our hiring process will we require payment or ask you to make deposits in your bank account.
- We will only ask for personal information when applying for a position via ourCareerspage or thereafter.
- We will never ask you to contact third parties to complete an application or be considered for a job.
- At no stage during our hiring process will we ask you to click a link to begin a one-way video interview.
- We do not use Google Hangouts WhatsApp or other third-party messaging platforms to recruit candidates or conduct interviews.
Please exercise caution. If something feels off about your interactions we encourage you to contact us atto confirm the authenticity of the message.
Your security is important to us and we appreciate your vigilance.
Required Experience:
Exec
Employment Type
Full-Time
Key Skills
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