Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Director or Senior Director, Regulatory Affairs

$195k - $330k

Kymera Therapeutics

Who we are:Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit  or follow us on X (formerly Twitter) or LinkedIn. How we work:PIONEER: We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.COLLABORATE: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.How you’ll make an impact:Act as the global regulatory strategy lead for Kymera’s IRF5 degrader program, developing and driving the overall program regulatory strategy across multiple immunology and inflammation (I/I) indications.Ensure global regulatory strategies are effectively and efficiently implemented and maintained in line with evolving regulatory and business needs.Lead program teams through major regulatory filings and interactions, including INDs, CTAs/IMPDs, briefing packages, and health authority meetings.Serve as the primary regulatory partner on the IRF5 program team, working closely with Clinical, CMC, Nonclinical, Quality, and Commercial colleagues.Provide sound, science-based, solution-oriented regulatory guidance and advice to cross-functional program teams through strategic and flexible application of experience and regulatory knowledge.Clearly communicate regulatory risks, opportunities, and recommendations to program teams and senior leadership.Manage and support junior regulatory team members, including coaching, mentoring, and professional development.Track relevant regulatory intelligence data and interpret and disseminate findings to internal teams.Monitor the development of emerging regulations and guidances and advise on their impact to programs or business operations.Contribute to building scalable regulatory processes and best practices as the team and pipeline grow.Skills and experience you’ll bring:Bachelor’s degree in a scientific discipline required; advanced degree preferred but not required.Director: 8–10 years of Regulatory Affairs experience. Senior Director: 10–12+ years of Regulatory Affairs experience.Demonstrated success acting as a regulatory lead, including substantial contribution to at least one marketing application submission and approvalDemonstrated ability to drive cross-functional teams to deliver on critical program regulatory milestones.Experience working in rheumatology, GI, and/or other immunology or inflammation-related disease indications strongly preferred.Direct experience leading a regulatory program through mid- and late-stage development.Experience and ability to lead teams to prepare for and conduct regulatory interactions and negotiations with health authorities (e.g., FDA, EMA).Excellent understanding and knowledge of global drug development and regulatory principles and practices (FDA, EMA, ICH), 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.Equal Employment OpportunityKymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.CompensationKymera 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.

Vacancy posted 20 days ago
Similar jobs that could be interesting for youBased on the Director or Senior Director, Regulatory Affairs in Watertown, MA vacancy
  • $220k - $370k

     ...Job Description Job Description Our Clinical Development team   is seeking a highly motivated and experienced Senior Director or VP of Regulatory Affairs. The ideal candidate will have a proven track record of leading successful BLA submissions and desires to be part... 
    Senior
    Summer work
    Work at office
    Flexible hours

    Compass Therapeutics

    Brighton, MA
    3 days ago
  • $210k - $320k

     ...cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.Position Overview: The Regulatory Director/Sr. Director Regulatory CMC will be responsible for preparing CMC and Quality related health authority agency correspondence... 
    Senior
    Full time
    Shift work
    3 days per week
    1 day per week

    Beam Therapeutics

    Cambridge, MA
    2 days ago
  • $245k - $300k

     ...Job Description Job Description Description: Sr. Director, Regulatory Affairs At Merida Biosciences, we are pioneering true precision...  ...Merida Biosciences is seeking an experienced and strategic Senior Director, Regulatory Affairs to lead and execute global regulatory... 
    Senior
    Local area

    Merida Biosciences

    Cambridge, MA
    10 days ago
  • Harvard University Central Administration seeks a Senior Director for the Harvard International Office. You will set the vision for international students, scholars, and staff, ensuring regulatory compliance and a resilient service portfolio across the university. You... 
    Senior
    Work at office

    Harvard Central Administration (CADM) Talent Acquisition

    Cambridge, MA
    4 days ago
  • A biotechnology company in Cambridge, MA is looking for a Senior Director of Biostatistics to lead statistical activities for clinical programs, provide input during regulatory submissions, and mentor junior statisticians. This role demands expertise in statistical analysis... 
    Senior

    BioSpace

    Cambridge, MA
    5 days ago
  • The Senior Director of the Harvard International Office at Harvard University provides strategic, operational, and financial leadership for the HIO. You will set the vision, ensure compliance with federal and institutional policies, and build a robust service portfolio... 
    Senior
    Work at office

    Harvard University

    Cambridge, MA
    2 days ago
  • Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory Leads, Senior Director is responsible for ensuring...  ..., enhancing their skills and knowledge in regulatory affairs Strong strategic planner with a proven ability to anticipate... 
    Senior
    Full time
    Local area

    Takeda

    Cambridge, MA
    2 days ago
  • $233k - $280k

     ...more at , and follow us on X, LinkedIn and Facebook.Role Summary: As Dyne advances toward commercialization, we are seeking a Senior Director, Business Strategy & Operations – Office of the CCO to work at the center of the Commercial organization and help shape how it... 
    Senior
    Full time
    Work at office
    Local area

    Dyne Therapeutics

    Waltham, MA
    a month ago
  • $275k - $315k

    Position OverviewBicara Therapeutics is seeking a strategic and experienced Senior Director of Regulatory Affairs to lead and execute US regulatory strategy for our biologics pipeline. Reporting to the VP, Regulatory Affairs, you will serve as the primary US regulatory... 
    Senior
    Full time
    Temporary work
    Work at office
    Local area
    3 days per week

    Bicara Therapeutics

    Boston, MA
    12 hours ago
  •  ...Senior Director, IT Compliance & Governance (Contractor) About the Company Innovative company designing & developing gene therapeutic products Industry Biotechnology Type Public Company Founded 2013 Employees 51-200 Categories Biotechnology... 
    Senior
    For contractors

    Confidential

    Boston, MA
    3 days ago
  • $195k - $330k

     ...the development and execution of global regulatory CMC strategies for degrader programs across...  ...strategic regulatory CMC guidance to senior leadership regarding health authority interactions...  ...readiness.Scale and lead the Regulatory Affairs CMC function as the pipeline and... 
    Senior

    Kymera Therapeutics

    Watertown, MA
    6 days ago
  • PharmaEssentia USA is seeking a Director of Regulatory Advertising & Promotion to lead regulatory review, governance, and compliance for promotional materials across media. You will partner with Commercial, Medical, Legal, and Regulatory teams to ensure scientific accuracy... 
    Senior
    Fixed term contract

    PharmaEssentia

    Burlington, MA
    1 day ago
  • Harvard Kennedy School in Cambridge, MA seeks an experienced Director, Principal & Major Gifts to manage a 75-100 prospect portfolio and...  ...for School priorities. You will work closely with faculty, senior administration and University officials to identify, qualify, solicit... 
    Senior

    Harvard University

    Cambridge, MA
    5 days ago
  •  ...to be onsite five days per week. Role Senior Director, Healthcare Compliance, reporting to the...  ...key external‑facing functions (Medical Affairs, Patient Services, and Patient Advocacy...  ...leader, fostering a “speak‑up” culture. Regulatory Intelligence & Governance Maintain deep... 
    Senior
    Work at office

    Kiniksa Pharmaceuticals

    Lexington, MA
    2 days ago
  • $225k - $275k

    Senior Director, Global Regulatory Strategy Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company...  .... Lead regulatory sub-teams and represent Regulatory Affairs on cross-functional governance and program teams, driving... 
    Senior
    Full time

    Centessa Pharmaceuticals, a wholly owned subsidiary of Eli L...

    Boston, MA
    2 days ago
  • $218.06k - $327.09k

    Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CAIntroduction to role: Are you ready to set the global regulatory vision for pioneering cell therapies and turn breakthrough... 
    Senior
    Hourly pay
    Full time
    Temporary work
    Start working today
    Work at office
    Flexible hours
    3 days per week

    AstraZeneca

    Boston, MA
    3 days ago
  • $210k - $245k

     ...therapies designed to selectively expand regulatory T cells and reset the immune system....  ...Medicines is seeking an experienced Director of Regulatory Affairs to serve as the company’s first...  ...clear, actionable recommendations to senior leadership. Help build and scale... 
    Full time
    Temporary work
    Work experience placement
    Work at office
    Flexible hours
    3 days per week

    Repertoire Immune Medicines

    Watertown, MA
    5 days ago
  • Harvard University Central Administration (CADM) seeks a Senior Director of Principal Gifts to lead a portfolio of high-capacity donors and prospects, with the potential to secure 8- and 9-figure gifts. The role partners with university leaders and fundraisers across Harvard... 
    Senior
    Work at office

    Harvard Central Administration (CADM) Talent Acquisition

    Cambridge, MA
    1 day ago
  • Novartis Group of Companies is seeking a Director of Portfolio Analytics to lead major analytics workstreams, shaping methodologies and delivering senior-level recommendations for enterprise and therapeutic areas. You will partner with senior stakeholders to interpret... 
    Senior

    Novartis Group Companies

    Cambridge, MA
    2 days ago
  • Flagship Pioneering seeks a Sr. Director, Strategy and Operations to drive execution across two Origination Teams in Cambridge, MA. You will partner with team leaders to align priorities, optimize workflows, and manage portfolio company initiatives, ensuring timely value... 
    Senior

    Flagship Pioneering

    Cambridge, MA
    5 days ago
  •  ...meeting patient needs using our novel therapies. Tasks The Director of Regulatory Affairs provides strategic and operational leadership to the...  ...collaborative leader to work across the organization in this senior regulatory role to help us build the required capabilities... 
    Work at office
    Local area

    Noema Pharma

    Watertown, MA
    3 days ago
  • $207k - $253k

    ## Director, Regulatory Affairs CMCApplylocations: MA - Waltham - Officetime type: Full timeposted on: Posted 3 Days Agojob requisition id: JR\_000763Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis... 
    Minimum wage
    Full time
    Local area
    Flexible hours

    Madrigalpharma

    Waltham, MA
    3 days ago
  • Harvard University’s Division of Continuing Education in Cambridge, MA, is seeking a Senior Associate Director to lead admissions operations, planning, and policy development. You will supervise the advising team, interpret admissions policies, and drive data-informed decision... 
    Senior

    Harvard University

    Cambridge, MA
    5 days ago
  • Lila Sciences in Cambridge, MA, is hiring a Director / Senior Director, New Product Planning to help shape Lila Origins, our asset creation arm, translating scientific vision into molecules, materials, and real-world ventures. You will work at the interface of science,... 
    Senior

    Lila Sciences

    Cambridge, MA
    2 days ago
  •  ...Scholar Rock, Inc. is seeking a Senior Director of Cybersecurity to serve as the company’s Chief Information Security Officer, shaping the overall cybersecurity strategy and roadmap for risk-based protection of people, data, and IP. You will partner with CIO and business... 
    Senior

    Jobleads-US

    Cambridge, MA
    1 day ago
  • Cambridge, MA USA Lila Sciences is hiring a Director / Senior Director, New Product Planning to help shape Lila Origins, our company and asset creation arm which partners to translate scientific vision into molecules, materials, and real‑world ventures. As a member of... 
    Senior

    Lila Sciences

    Cambridge, MA
    2 days ago
  • Flagship Pioneering is looking for a Senior Director, Strategy and Operations for Flagship Labs in Cambridge, MA. You will partner with Origination Team Leaders to align priorities, track KPIs, and optimize program management across portfolio companies. You will lead cross... 
    Senior

    Flagship Pioneering

    Cambridge, MA
    4 days ago
  • Amylyx Pharmaceuticals is seeking a Director of Biostatistics to oversee statistical leadership in clinical trials and regulatory submission strategies. Your role includes collaborating with internal and external stakeholders to ensure the success of the clinical development... 
    Senior
    Remote work

    Amylyx Pharmaceuticals

    Cambridge, MA
    2 days ago
  •  ...Scorpion Therapeutics in Cambridge, MA seeks a Senior Director, New Product Planning to lead commercial assessment for pipeline assets, anemia market opportunities, and business development activities. You will build market sizing, competitive evaluations, and strategic... 
    Senior

    Jobleads-US

    Cambridge, MA
    1 day ago
  • Akebia Therapeutics is seeking a Senior Director, New Product Planning to lead commercial assessments, generate actionable...  ...product lifecycle. You will partner with R&D, Medical Affairs, Business Development, Regulatory, Commercial and Executive Leadership to inform... 
    Senior

    Akebia Therapeutics

    Cambridge, MA
    4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Director or Senior Director, Regulatory Affairs. Be the first to apply!