Kymera Therapeutics

Director or Senior Director, Regulatory CMC

Kymera Therapeutics • $195K — $330K *
Watertown, MA 02472In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • BS, MS, or PhD in Chemistry, Pharmaceutics, Biochemistry, Chemical Engineering, or a related scientific discipline
  • 10+ years of progressive Regulatory Affairs CMC experience in the biotechnology or pharmaceutical industry
  • Deep experience in late-stage regulatory CMC activities
  • Extensive hands-on small molecule CMC experience
  • Demonstrated success managing CMC content for small molecule INDs/CTAs and marketing applications
  • Strong working knowledge of global CMC regulatory requirements
  • Excellent written and verbal communication skills

Responsibilities

  • Lead development and execution of global regulatory CMC strategies for degrader programs
  • Serve as regulatory CMC lead, collaborating with cross-functional teams
  • Author, review, and approve CMC content for various regulatory submissions
  • Provide strategic CMC guidance to senior leadership on health authority interactions
  • Lead preparation for meetings with global health authorities on CMC matters
  • Monitor and communicate evolving global CMC regulatory guidance
  • Collaborate with CDMOs to ensure regulatory compliance

Benefits

  • Competitive compensation package with performance-driven pay
  • Annual bonus and equity participation
  • Comprehensive benefits package
Full Job Description


How you'll make an impact:
  • Lead the development and execution of global regulatory CMC strategies for degrader programs across all stages of development, from early-stage activities through late-stage development and approval with specific emphasis on late-stage activities.
  • Serve as the regulatory CMC lead for multiple programs, partnering closely with CMC, Quality, Non-Clinical, and Clinical Development teams to align regulatory strategy with program timelines.
  • Author, review, and approve CMC content for regulatory submissions, including INDs/CTAs, briefing documents, NDA/MAA modules, annual reports, and amendments/supplements.
  • Provide strategic regulatory CMC guidance to senior leadership regarding health authority interactions, submission risk, and mitigation planning.
  • Lead preparation for, and participate in, meetings and correspondence with FDA, EMA, and other global health authorities on CMC matters.
  • Monitor, interpret, and communicate evolving global CMC regulatory guidance and requirements, advising cross-functional teams on impact and implementation.
  • Collaborate with and provide regulatory oversight of CDMOs and other external manufacturing/testing partners to ensure regulatory compliance and submission readiness.
  • Scale and lead the Regulatory Affairs CMC function as the pipeline and organization grow.


Skills and experience you'll bring:
  • BS, MS, or PhD in Chemistry, Pharmaceutics, Biochemistry, Chemical Engineering, or a related scientific discipline.
  • 10+ years of progressive Regulatory Affairs CMC experience in the biotechnology or pharmaceutical industry.
  • Deep experience in late-stage (pivotal trials through NDA/MAA and post-approval) regulatory CMC activities.
  • Extensivehands-on small molecule CMC experience, including direct work on small molecule drug substance and drug product development, control strategy, and lifecycle management.
  • Demonstrated success independently authoring, reviewing, and managing CMC content for small molecule INDs/CTAs and marketing applications (NDA/MAA), with hands-on experience preparing for and participating in health authority interactions.
  • Strong working knowledge of global CMC regulatory requirements and guidance for small molecule products across the product lifecycle (FDA, EMA, ICH, and other regional health authorities).
  • Experience with small molecule analytical method development/validation, specification setting, and post-approval change management.
  • Excellent written and verbal communication skills, with the ability to translate complex technical and scientific information into clear, actionable regulatory strategy.
  • Proven ability to lead cross-functionally and influence without direct authority in a fast-paced, matrixed drug development environment.
  • Strong organizational and project management skills, with the ability to manage multiple programs and competing priorities simultaneously.


Compensation
  • Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay.
  • The anticipated base salary range for this role is $195,000 - $330,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.
  • Actual salary is based on a holistic evaluation of the specific role/level as well as each candidate's depth of experience and the capabilities they bring to the position.

About Kymera Therapeutics

Kymera Therapeutics is a clinical-stage biopharmaceutical company that is focused on discovering and developing novel small molecule therapeutics that selectively degrade disease-causing proteins by harnessing the body's own natural protein degradation system. The company's proprietary targeted protein degradation platform, Pegasus, is designed to harness the body's natural protein recycling machinery to degrade disease-causing proteins, with a focus on undruggable and difficult-to-drug targets. Kymera's initial programs are focused on oncology and immunology, with a goal of delivering transformative therapies for patients with previously untreatable diseases. Kymera was founded in 2015 and is headquartered in Cambridge, MA.
Learn more about Kymera Therapeutics
Size
75 employees
Market Cap
$1.4 billion
Industry
Pharmaceuticals & Biotech
Founded
2017
NASDAQ
KYMR
* Ladders Estimates

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