Associate Director / Director, Regulatory Affairs
Company: Adicet Bio, Inc.
Location: Redwood City
Posted on: March 19, 2023
Job Description:
Associate Director Director Regulatory Affairs - Careers At
Adicet Bio Back To Openings Associate Director / Director,
Regulatory Affairs Department: Regulatory Location: Redwood City,
CA
START YOUR APPLICATION JOIN US! Adicet Bio, Inc. is a clinical
stage biotechnology company discovering and developing allogeneic
gamma delta T cell therapies for cancer. Adicet is advancing a
pipeline of "off-the-shelf" gamma delta T cells, engineered with
chimeric antigen receptors (CARs) and adaptors (CAds), to enhance
selective tumor targeting and facilitate innate and adaptive
anti-tumor immune response for durable activity in patients. For
more information, please visit our website at
https://www.adicetbio.com . ASSOCIATE DIRECTOR / DIRECTOR,
REGULATORY AFFAIRS Adicet Bio is seeking an exceptionally talented
and motivated individual to join our team as Associate
Director/Director, Regulatory Affairs. This position will be
responsible for developing and executing innovative regulatory
strategies in support of the nonclinical and clinical development
for our early development pipeline products within the Regulatory
Affairs department. In this lead, direct role, the successful
candidate will provide dynamic leadership and direction to senior
management and product development teams and will work in close
partnership with the nonclinical and clinical leadership to achieve
development milestones in an efficient and compliant manner. The
role would require a strong scientific background with
understanding and experience in GLP, GCP, and relevant regulatory
guidelines to contribute to and shape the overall clinical
development strategy. The successful candidate will interface
cross-functionally in a matrixed environment to integrate
nonclinical and clinical plans with overall development plans and
ensure planning, coordination, and communication to develop timely
and robust regulatory strategies and submissions to meet overall
program objectives/milestones. Key responsibilities:
- Manage all aspects of nonclinical and clinical regulatory
strategy development for Adicet products (early- to
late-stage/registration/post-market).
- Lead teams in examining regulatory strategy options, provide
relevant regulatory guidance.
- Identify and assess regulatory risks and critical-path
activities associated with nonclinical and clinical development
programs and work to identify regulatory strategies to mitigate
risks.
- Monitor and analyze regulatory agency activities regarding
nonclinical and clinical development and assess potential impact on
the Adicet development programs and understand the regulatory
landscape.
- Serve as Regulatory Lead on cross functional project teams to
achieve project milestones/goals.
- Lead global regulatory submission development - Responsible for
planning, coordinating, and developing high quality, compliant and
timely regulatory submissions according to current regulatory
requirements and guidance to obtain efficient and timely regulatory
approvals (IND/IMPD, BLA/MAA, pre-meeting briefing documents,
etc.).
- Assist in organization and management of staff within the RA
group, including coaching, career development and oversight of
work, as required. Qualifications:
- Master's degree in life sciences, or advanced degree
preferred.
- Prior experience with cell or gene therapies
- Prior experience in oncology drug development
- 10+ years working within the biotech/pharmaceutical industry.
8+ years of pharma and/or biotech regulatory CMC-experience.
- Depth Knowledge of GLP and GCP regulatory requirements in
domestic and globally.
- Ability to lead matrixed teams, drive and influence effective
collaborations.
- Strong scientific writing and oral communication skills with
ability to summarize clearly and succinctly and tailor messaging to
target audience.
- Initiative-taking, self-disciplined, and able to function
independently as well as part of a team.
- Proficient in various computer applications such as MS Project,
Office suite, Smartsheet, etc. Adicet Bio requires all workers to
be fully vaccinated against COVID-19, including the booster dose.
At Adicet, our people are our greatest focus. We believe that
attracting and retaining the best and brightest is the key to
achieving our mission to deliver best-in-class gamma delta T cell
therapies for patients fighting cancer. We offer a competitive
compensation package including base salary, annual cash bonus,
long-term incentives (equity), Employee Stock Purchase Plan (ESPP)
and a 401(k) with ROTH and a 4.5% Company match. To ensure the
wellness of our employees and their loved ones, we offer
comprehensive health plans (medical, dental, vision, etc.),
Flexible Health and Commuter Spending Accounts (FSA) and a company
matched Health Savings Account (HSA). We also offer a life,
AD&D, short and long-term disability insurance, and legal, pet,
and various other voluntary insurance programs. We also believe our
greatest ideas come when we are refreshed and focused, and we offer
generous paid time-off including 12 company holidays with
end-of-year shutdown, vacation, sick time, and paid parental leave.
Adicet is located in a state-of-the-art facility and works to
create an incredible office experience with an onsite gym and
various other fitness options, abundant, zero-cost, onsite parking
with electric vehicle charging stations and free shuttle
(Caltrain), company subsidized lunches (delivered onsite daily) and
fully stocked breakrooms. In compliance with California's pay
transparency law and in pursuit of pay equity and fairness, we
publish salary ranges for all open positions. The pay scale range
for this role is $165,000.00 - $250,000.00 annualized base salary.
The salary of the finalist selected for this role will be set based
on a variety of factors, including but not limited to, their
qualifications (education, experience, specialty, and training),
and peer and market data. This listed salary range represents the
Company's good faith and reasonable estimate of the range of
possible compensation at the time of posting. START YOUR
APPLICATION
Keywords: Adicet Bio, Inc., Redwood City , Associate Director / Director, Regulatory Affairs, Executive , Redwood City, California
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