- Job Type: Full-Time
- Function: Regulatory Affairs
- Industry: Biotechnology
- Post Date: 11/27/2023
- Website: tenayatherapeutics.com
- Company Address: 171 Oyster Point Blvd, South San Francisco, California 94080, US
About Tenaya TherapeuticsTenaya Therapeutics is a clinical stage biotechnology company. The Company was founded in 2016 by leading cardiovascular scientists from the David J. Gladstone Institutes and the University of Texas Southwestern Medical Center.
Tenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Tenaya’s most advanced candidates include TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM), TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC), and TN-301, a small molecule HDAC6 inhibitor being initially developed for heart failure with preserved ejection fraction (HFpEF). Tenaya also has multiple early-stage programs progressing through preclinical development.
Tenaya is headquartered in South San Francisco, California, USA, with a team that comprises over 140 employees. Inspired by the majesty of Tenaya Peak in Yosemite National Park, our name represents the tenacity of our team in reaching our ultimate peak – the delivery of new therapies for heart disease to the patients who need them.
For more information, please visit www.TenayaTherapeutics.com and follow us on LinkedIn.
Diversity & Inclusion is a core Value for Tenaya Therapeutics, and we encourage those from under-represented communities to apply.
- Develop and implement global regulatory strategies and serve as regulatory subject matter expert and influential leader within the organization.
- Author and review regulatory submissions for accuracy and alignment with global regulatory strategies.
- Lead/contribute to cross-functional initiatives, collaborating closely with clinical, manufacturing, quality, and program leadership. Develop best practices as needed.
- Mentor and manage Regulatory Affairs team members (direct/indirect reports), providing guidance and growth opportunities. Oversee regulatory consultants’ activities.
- Provide regulatory support for clinical operations activities (e.g., review of essential documents, and development and review of consent forms, etc.).
- Participate in the review of educational materials.
- Provide updates to management, including executives.
- Support business development activities by providing regulatory expertise and due diligence assessments.
- Provide direction and decision-making over global regulatory strategy involving clinical and approval objectives at Core and Project team meetings.
- Interact directly and/or indirectly with US and ex-US Health Authorities.
- Responsible for management of clinical trial applications (EU/ROW), preparing meeting requests, and briefing packages.
- Act as the primary contact with Regulatory Agencies, representing the company in meetings and negotiations.
- Monitor changes in regulatory requirements and emergence of new regulations, proactively identifying opportunities and potential challenges for our gene therapy products.
- Ensure company compliance with applicable global regulatory requirements and provide support for regulatory inspections and audits.
- Develop and maintain relationships with key stakeholders, including regulatory authorities, external partners, and industry associations.
- BS/BA minimum. Advanced (MS, PhD, or PharmD) degree preferred.
- Ex-US experience highly desirable.
- 12+ years in regulatory affairs (with experience in gene therapy), with at least 5 years in a leadership role.
- Ability to come onsite weekly (local hybrid model).
- Proven track record of multiple successful regulatory submissions and approvals (IND, NDA, BLA, MAA, CTAs, JNDA, etc.) in the gene therapy space.
- Demonstrated ability to work independently and within a group setting, and to interact effectively with various functional groups.
- Flexible and phase appropriate mindset.
- Strong knowledge of global regulatory requirements and guidelines, including FDA, EMA, and other relevant authorities.
- Ability to work effectively in a fast-paced, dynamic environment and adapt to changing priorities.
- A commitment to the highest ethical standards and scientific rigor.
- High level of attention to detail, and be proficient with Microsoft Office applications, Adobe, Starting Point document templates.
Tenaya takes into account a wide range of factors when determining compensation including not limited to skill sets, experience, interview performance and organizational need.
We will make an offer based on geo-located salary bands based on data collected from Aon/Radford. As of 1/1/2023, for individuals assigned and/or hired to work in the San Francisco Bay Area in the state of California, your base salary will fall within the band(s) below. This base salary range is an estimate, and the actual base salary may vary based on Tenaya’s compensation practice. Please also keep in mind that the benefits, bonus, and the equity portion of your offer is not included in these numbers and represents a significant portion of your total rewards package at Tenaya. Should you reach the verbal offer stage of Tenaya’s hiring process, we will review the base salary, benefits, bonus target and equity grant value with you at that time. Executive Director, Regulatory range is $275,000 - $325,000.
We offer a dynamic start-up environment and a collaborative, passionate team that is focused on a compelling vision and mission.
We offer competitive salary and stock options. Excellent medical and non-medical benefits. Paid vacation, sick time and holidays.
State-of-the-art, built-to-suit office and lab space, part of a larger cluster of biotech companies, with amenities that include a bowling alley and onsite gym.
Shuttle service to/from Caltrain, BART and the South San Francisco Ferry.
Tenaya is proud to be an equal opportunity workplace.