Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowPosted 102 days ago

Lead, Regulatory Affairs CMC - Cell Therapy & Novel Therapeutics

retro5 open roles

Pay
$225,000 – $260,000 a year
Where
Redwood City, CA
Work mode
On site
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowLead, Regulatory Affairs CMC - Cell Therapy & Novel Therapeuticsretro · Redwood City, CA

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on retro's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

7.8% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 1.6%1 day
  2. 3.4%3 days
  3. 7.8%7 days
  4. 14.3%14 days
  5. 33.7%30 days
This job: posted 102 days ago

The posting

Retro develops therapies for diseases driven by the biology of aging. We focus on cellular reprogramming and autophagy to rejuvenate cell and tissue function with the ultimate aim of adding 10 years to healthy human lifespan.

We’re hiring an experienced new member of our Regulatory team who will own the strategy and operations for our Chemistry, Manufacturing, and Controls (CMC) regulatory work. As one of the earliest members of the Regulatory Affairs team, you will work across Retro’s programs and play a leading role in building out the regulatory CMC capabilities and strategies to achieve our ambitious mission and tackle aging. You will report directly to the Head of Regulatory Affairs.

This position is an onsite role based in Redwood City.

About you:

You are a builder and doer who can set clear, global CMC regulatory strategies and roll up your sleeves to execute them at speed. You are energized by complex CMC challenges, especially in cell therapy, and you anticipate questions before they become risks. You translate technical details into clear regulatory narratives that resonate with health authorities, and you are comfortable serving as the CMC regulatory point person in high-stakes health-authority interactions.

You have high-collaboration and low-ego tendencies, with the ability to align cross-functional technical teams and external partners around a shared regulatory CMC plan and clear deliverables. You bring strong operational discipline, enjoy creating structure when needed, and are mission-driven with genuine motivation to advance longevity and aging biology for the benefit of humanity.

In this role, you will:

  • Be accountable for the regulatory CMC activities for Retro’s pipeline, which has an emphasis on cell therapies but also contains small molecules, gene therapies, and AI-designed proteins.
  • Develop the regulatory CMC strategy for each program and lead the execution of global CMC regulatory plans.
  • Lead the preparation of the CMC dossier for INDs/CTAs and marketing applications, as well as the CMC documents for amendments, annual reports, and other CMC regulatory submissions.
  • Act as Retro’s regulatory liaison with health authorities for CMC communications and submissions.
  • Lead health-authority meetings with FDA and other health authorities for CMC-related topics.
  • Lead the responses to health-authority queries and information requests related to CMC.
  • Identify regulatory CMC risks and develop creative and innovative mitigation strategies.
  • Partner closely with key internal functions, including Analytical Development, Process Development, Scientific Operations, and Quality.
  • Provide regulatory CMC guidance and oversight to external CDMOs and other vendors.
  • Help establish scalable regulatory CMC processes and approaches in a growing biotech organization.

You will thrive in this role if you:

  • Have a bachelor’s degree in a life sciences discipline or equivalent (advanced degree preferred).
  • 7+ years of hands-on experience in regulatory CMC.
  • Demonstrated experience leading CMC regulatory strategy for cell therapies.
  • Experience working in early phase development (IND/CTA-enabling through Phase 1/2) with pragmatic, stage-appropriate CMC approaches.
  • Proven ability to lead cross-functional workstreams, manage multiple priorities, and deliver high-quality outputs under tight timelines.
  • Strong interest in longevity and aging biology, and motivation to work in a field where the playbook is still being written.

It’s a bonus if you:

  • Have experience working on iPSC-derived cell therapies.
  • Have experience across multiple product modalities (e.g., cell/gene therapy, small molecules, biologics, etc.).
  • Experience in late phase development (e.g., Phase 3) and registrational/commercial settings.
  • Extensive global experience, including in non-traditional jurisdictions and emerging markets.

We take pride in cultivating an environment that fosters collaboration, open communication, and authenticity. We believe that great results are best delivered by a highly creative team working in concert. We are an equal opportunity employer; we do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We are diverse in background and singular in mission.

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against retro's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on retro's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    retro's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.