Full-Time

Associate Director or Director

Regulatory Affairs

Confirmed live in the last 24 hours

Kymera Therapeutics

Kymera Therapeutics

201-500 employees

Develops targeted protein degradation therapies

Biotechnology
Healthcare

Senior, Expert

Belmont, MA, USA

Hybrid work model with a minimum of 3 days/week in the office.

Category
Risk & Compliance
Legal & Compliance
Requirements
  • Bachelor’s degree in a scientific discipline, advanced degree preferred but not required.
  • 8-10 years of Regulatory Affairs experience.
  • Experience acting as a regulatory program lead with the ability to drive cross functional teams to deliver on critical program regulatory milestones.
  • Experience working in dermatology, respiratory, rheumatology and/or other immunological related disease indications.
  • Direct experience leading a broad range of regulatory submissions from early to late-stage development.
  • Experience and ability to lead teams to prepare for and conduct regulatory interactions and negotiations.
  • Excellent understanding and knowledge of global drug development and regulatory principles and practices with the motivation to continually learn and build on existing skills and knowledge base.
  • Demonstrated ability to lead teams, internal and external, through excellent interpersonal and communication skills.
Responsibilities
  • Act as the global regulatory strategy lead for one or more assigned programs, including developing and driving overall program regulatory strategy, managing and overseeing all regulatory submissions, and acting as the Kymera point of contact with US FDA and other global health authorities.
  • Provides sound, science-based, solution-oriented regulatory guidance and advice to cross functional program teams through strategic and flexible application of experience and regulatory knowledge.
  • Leads and manages program teams through major regulatory filings and interactions.
  • Tracks relevant regulatory intelligence data and interprets and disseminates to internal teams.
  • Conducts external regulatory due diligence.
  • Monitors the development of emerging regulations and guidance’s and advises on impacts to programs or business operations.
  • Manages and supports junior regulatory team members.
Desired Qualifications
  • Advanced degree preferred but not required.

Kymera Therapeutics develops treatments by targeting and breaking down specific proteins that contribute to diseases, particularly cancer and immune disorders. Their main technology, the Pegasus Platform, enables them to identify these harmful proteins and create drug candidates aimed at effectively treating various conditions. Unlike many competitors, Kymera focuses on targeted protein degradation, which can lead to more precise therapies. The company's goal is to create next-generation medicines that address unmet medical needs, supported by partnerships with organizations like Sanofi to enhance their research and development efforts.

Company Stage

IPO

Total Funding

$191.6M

Headquarters

Cambridge, Massachusetts

Founded

2016

Growth & Insights
Headcount

6 month growth

0%

1 year growth

0%

2 year growth

2%
Simplify Jobs

Simplify's Take

What believers are saying

  • Kymera raised $225M and $275M in public offerings, boosting financial resources.
  • HSBC's investment indicates strong confidence in Kymera's business model and prospects.
  • Partnership with Neosphere Biotechnologies opens new therapeutic opportunities in molecular glue discovery.

What critics are saying

  • Increased competition in protein degradation could impact Kymera's market share.
  • Regulatory scrutiny may delay clinical trials and drug approval timelines.
  • Dependence on key partnerships like Sanofi could affect revenue if altered.

What makes Kymera Therapeutics unique

  • Kymera's Pegasus Platform enables precise identification and degradation of disease-causing proteins.
  • The company focuses on targeted protein degradation, a novel approach in drug development.
  • Kymera's strategic partnership with Sanofi enhances its credibility and market reach.

Help us improve and share your feedback! Did you find this helpful?