Senior Director, Regulatory Affairs - CMC
Company: Adicet Bio, Inc.
Location: Redwood City
Posted on: January 21, 2023
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 . SENIOR DIRECTOR,
REGULATORY AFFAIRS - CMC Adicet Bio is seeking an exceptionally
talented and motivated individual to join our team as Senior
Director, Regulatory Affairs (CMC). This position will be
responsible for developing and executing innovative regulatory
strategies in support of the chemistry, manufacturing, and controls
(CMC) 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 CMC/Quality leadership to
achieve development milestones in an efficient and compliant
manner. The role would require a strong scientific background with
understanding and experience in cGMP manufacturing, analytical
practices, and relevant regulatory guidelines to contribute to and
shape the overall manufacturing strategy. The successful candidate
will interface cross-functionally in a matrixed environment to
integrate CMC 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:
- Lead and manage all aspects of CMC regulatory strategy
development for Adicet products (early- to
- Lead teams in examining regulatory strategy options, provide
relevant regulatory guidance.
- Identify and assess regulatory risks and critical-path
activities associated with CMC development programs and work to
identify regulatory strategies to mitigate risks.
- Monitor and analyze regulatory agency activities regarding CMC
development and assess potential impact on the Adicet development
programs and understand the regulatory landscape.
- Evaluate proposed manufacturing changes for global impact and
provide strategic regulatory strategies that support compliant
- Serve as CMC Regulatory Lead on cross functional project teams
to achieve project milestones/goals.
- Serve as the Regulatory point of contact for Contract
Manufacturing Organizations and Qualified Persons.
- Lead global CMC regulatory submission development - Responsible
for planning, coordinating, and developing high quality, compliant
and timely CMC (Quality) 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:
- Bachelor's degree (or equivalent) in life sciences, masters or
advanced degree preferred.
- Prior experience with cell or gene therapies
- 10+ years working within the biotech/pharmaceutical industry.
8+ years of pharma and/or biotech regulatory CMC-experience.
- Depth Knowledge of cGMP, CMC regulatory requirements in
domestric and globally.
- Ability to lead matrixed teams, drive and influence effective
- Strong scientific writing and oral communication skills with
ability to summarize clearly and succinctly and tailor messaging to
- 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 $217,000 - $299,000 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.
Keywords: Adicet Bio, Inc., Redwood City , Senior Director, Regulatory Affairs - CMC, Executive , Redwood City, California
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