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

Open nowPosted 36 hours agoWe saw it 24 min after it went up

(Senior) Director, Regulatory Affairs CMC

Braveheart Bio7 open roles

Pay
$210,000 – $305,000 a year
Where
San Francisco, CA or Remote or Hybrid
Work mode
Remote
Get the CV for this job

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

Your applicationOpen now(Senior) Director, Regulatory Affairs CMCBraveheart Bio · San Francisco, CA or Remote or Hybrid

  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 Braveheart Bio'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.

11.4% of postings close within 7 days. Measured by our own scanner across the market. Braveheart Bio postings stay open a median of 23 days.

Share of postings closed within
  1. 2.0%1 day
  2. 4.2%3 days
  3. 11.4%7 days
  4. 17.5%14 days
  5. 34.2%30 days
  6. 43.5%60 days
This job: posted 36 hours ago

Braveheart Bio median: 23 days open

The posting

About us:

Braveheart Bio is a clinical-stage biopharmaceutical company focused on developing therapies for patients with hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases. Our lead product candidate, BHB-1893, is a next-generation oral small-molecule cardiac myosin inhibitor (CMI) being developed for the treatment of obstructive HCM (oHCM) and non-obstructive HCM (nHCM). Braveheart’s goal is to improve the treatment options for these patients by enhancing speed of onset, depth of gradient response, systolic safety, reversibility and reducing prescribing complexity.

With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a high-profile and rapidly evolving therapeutic area.

The role:

The (Senior) Director, Regulatory Affairs CMC will serve as the Global CMC Regulatory Lead and provide regulatory CMC leadership for Braveheart Bio’s HCM program. Reporting to the Vice President of Regulatory Affairs, this hands-on individual contributor will develop and execute the global CMC regulatory strategy that carries our lead asset from Phase 3 through registration, launch supply, and lifecycle management. This role will play a central part in building a CMC data package that meets FDA and international expectations and in preparing the company for commercial launch. This role will also help build the CMC regulatory processes and infrastructure as Braveheart continues to scale.

This is an exciting opportunity to join a regulatory function at a pivotal stage in Braveheart’s development and make a direct impact on the company’s path to global development. The ideal candidate brings thorough knowledge of US and international CMC regulations and ICH guidelines as they apply to pharmaceutical development and manufacturing.

Key responsibilities:

  • Serve as Global CMC Regulatory Lead for the HCM program, developing and executing CMC regulatory strategies that support successful registration, launch, and post-approval lifecycle management.
  • In partnership with the CMC team, prepare the CMC sections of INDs/CTAs, IMPDs, and marketing applications (NDA/MAA), including Module 3 (3.2.S and 3.2.P) and Quality Overall Summary content.
  • Lead the CMC regulatory strategy for manufacturing technology transfers and process changes, including comparability assessments and bridging between manufacturing sites.
  • Provide regulatory input into process validation/PPQ, control strategy, and specifications to ensure readiness for registration and commercial launch.
  • Provide regulatory oversight of CDMO and CTO partners, partnering with CMC, Quality, and Supply Chain on batch documentation, specifications, stability, and change control.
  • Serve as the primary CMC point of contact with FDA and other health authorities; lead CMC-related agency meetings (e.g., Type B/C, pre-NDA) and coordinate meeting packages and responses to information requests.
  • Support pre-approval inspections in partnership with Quality.
  • Proactively identify CMC regulatory risks and develop mitigation strategies; communicate risks and options clearly to governance forums and core team meetings.
  • Ensure CMC content in regulatory submissions is complete, well-written, and meets all applicable requirements for the program's development phase.
  • Manage post-approval CMC changes, supplements, and variations, and provide regulatory assessments of proposed changes.
  • Maintain broad and current knowledge of CMC regulatory requirements and guidelines (including ICH Q-series) across US and international markets.

Required experience & skills:

  • Bachelor's degree required; advanced degree in a life science, pharmaceutical science, or related field (PhD, PharmD, or MS) preferred.
  • A minimum of 12 years in Regulatory Affairs CMC, including serving as the CMC Regulatory Lead for late-stage or commercial products.
  • Hands-on experience authoring and reviewing CMC sections for INDs/CTAs and marketing applications (NDAs/MAAs)
  • Direct experience supporting commercial readiness, including process validation/PPQ, launch supply, and pre-approval inspection preparation.
  • Experience with technology transfer and site-to-site comparability
  • Experience overseeing CDMOs from a CMC regulatory perspective.
  • Experience with small-molecule drug substance and drug product CMC (oral solid dose experience preferred)
  • Experience leading CMC-related interactions and meetings with FDA and other health authorities.
  • Experience with post-approval CMC changes, supplements, and variations is preferred.
  • Thorough knowledge of US and international CMC regulations and ICH guidelines as they apply to pharmaceutical development and manufacturing.
  • Strong strategic skills including demonstrated ability to make complex decisions and defend difficult positions.
  • Strong track record of strategic leadership, collaboration, and influence in cross-functional settings
  • Strong written and verbal communication skills with a collaborative, team-oriented approach
  • Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity.
  • Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude

Base Salary Range: $210,000 - $305,000

This role is also eligible for a competitive total rewards package, which may include an annual bonus, equity, and a comprehensive benefits offering.

We are an equal opportunity employer.

We are committed to inclusion and diversity, and we do not discriminate on the basis of race, gender, religion, gender, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.

Braveheart participates in the federal E‑Verify program to confirm employment authorization for all new hires.

To learn more about E-Verify please review this poster.

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 Braveheart Bio'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 Braveheart Bio'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

    Braveheart Bio'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.