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

Senior Regulatory Affairs Leader - Biopharma Submissions

Kids For The Future

Kids for the Future in Waltham, MA is seeking an Associate Director, Regulatory Affairs to lead regulatory activities for product development, particularly focusing on Thyroid Eye Disease. This role requires a proven track record in Regulatory Affairs, strong communication skills and a commitment to ethical standards. Join a team dedicated to developing best-in-class medicines and ensure regulatory compliance as we advance our robust pipeline. This position offers competitive pay, comprehensive benefits, and opportunities for growth. #J-18808-Ljbffr

Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Affairs Leader - Biopharma Submissions in Waltham, MA vacancy
  •  ...Bicara Therapeutics is seeking a Senior Director of Regulatory Affairs in Boston. This role will lead US regulatory strategy for the biologics pipeline, overseeing regulatory submissions and health authority interactions. The ideal candidate will have 10–12 years of experience... 
    Senior
    Work at office
    3 days per week

    Bicara Therapeutics

    Boston, MA
    3 days ago
  • $120k - $150k

    A medical device company in Massachusetts seeks a Regulatory Affairs lead dedicated to clinical and medical device products. This role involves overseeing FDA submissions and managing clinical studies. Candidates should have 7-10 years of experience in Clinical Affairs... 
    Senior
    Remote job

    Evident Microscopy

    Needham Heights, MA
    4 days ago
  • $154k - $182k

     ...Senior Manager, Regional Regulatory Lead-North America for Vaccines CSL Seqirus is a...  ...within Global Regulatory Affairs & Safety (GRAS) organization...  ...CSL as: Regulatory leader who leverages North America...  ...documentation required for submission and supports response to... 
    Senior
    Local area
    3 days per week

    Seqirus

    Waltham, MA
    10 days ago
  • $154.4k - $242.55k

     ...quality standards. The role involves leading a team, reviewing clinical materials, managing quality issues, and supporting regulatory submissions. Ideal candidates have a relevant degree, proven leadership, and extensive experience in a pharmaceutical environment. The... 
    Senior

    Takeda

    Lexington, MA
    2 days ago
  •  ...Mass Digital Health is seeking a Senior Regulatory Affairs Specialist in Waltham, Massachusetts. In this role, you will lead the regulatory efforts...  ...5-7+ years in regulatory affairs, especially with FDA submissions. The position offers a competitive salary range of $85,600... 
    Suggested

    Mass Digital Health

    Waltham, MA
    2 days ago
  • $246.33k - $304.29k

    Akebia Therapeutics is seeking a Senior Director, Regulatory Affairs in Cambridge, MA to lead regulatory strategy and submissions for innovative therapies addressing chronic kidney disease. This role demands extensive regulatory experience, with leadership responsibilities... 
    Senior
    Flexible hours

    Akebia-Therapeutics-

    Cambridge, MA
    1 day ago
  •  ...Xenon Pharmaceuticals Inc. is seeking a Senior Manager for Regulatory Affairs Operations at its Needham, MA office. This role involves supporting global regulatory submissions through effective collaboration with cross-functional teams. Ideal candidates will have over... 
    Senior
    Work at office

    Xenon Pharmaceuticals Inc.

    Needham Heights, MA
    2 days ago
  •  ...A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission planning, ensuring compliance with regulatory authorities, and managing multiple priorities. Candidates... 
    Senior
    Remote work

    Barrington James

    Boston, MA
    3 days ago
  •  ...Wolters Kluwer N.V. is seeking a Senior Regulatory Affairs Specialist in Waltham, Massachusetts. This critical role involves supporting the expansion of our Software as a Medical Device (SaMD) portfolio globally, guiding product teams through compliant design and high-... 
    Senior

    Wolters Kluwer N.V.

    Waltham, MA
    2 days ago
  •  ...A healthcare technology company is seeking a Sr. Regulatory Affairs Specialist in Somerville, Massachusetts, to support the commercialization...  ...compliance with FDA regulations, and preparing regulatory submissions. Ideal candidates will have a bachelor’s degree, extensive... 
    Senior
    Remote work

    Hmixray

    Somerville, MA
    3 days ago
  • $186k - $200k

     ...Director, Quality to lead GMP technical transfer activities from development to commercial manufacturing, ensuring compliance with regulatory requirements and company standards. Located in Lexington, MA, the role requires a minimum of 10 years of pharma experience and a... 
    Senior

    Kiniksa Pharmaceuticals

    Lexington, MA
    2 days ago
  •  ...A leading biomedical company in Waltham is seeking a Senior Manager for Software Quality Assurance to oversee software compliance in medical devices. The role demands at least 10 years of experience in QA and leadership within regulated industries. Key responsibilities... 
    Senior
    Flexible hours

    Nova Biomedical

    Waltham, MA
    2 days ago
  • $137k - $215.27k

     ...for a professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory CMC or Device...  ...Responsibilities include executing regulatory strategies and managing submissions. The position offers a hybrid work model, with a salary... 
    Senior

    Initial Therapeutics, Inc.

    Boston, MA
    2 days ago
  • $120k - $180k

    Medtronic is seeking a Principal Regulatory Affairs Specialist based in Boston, Massachusetts. In this role, you will be integral to launching...  ...expertise, preparing necessary documentation for product submissions, and engaging with regulatory authorities. This position... 
    Senior

    Medtronic

    Boston, MA
    2 days ago
  •  ...translating marketing, data, and compliance needs into actionable solutions. The ideal candidate will have 7+ years of experience in the Biopharma industry, strong skills in marketing data and consent management, and a collaborative spirit. This position offers competitive... 
    Senior

    Biogen, Inc.

    Cambridge, MA
    4 days ago
  • $92k - $138k

    Medtronic is seeking a Senior Regulatory Affairs Specialist in Boston, Massachusetts. This role is primarily responsible for managing regulatory...  ...Instrument product portfolio. Duties include preparing submissions, interacting with regulatory authorities, and ensuring compliance... 
    Senior

    Medtronic

    Boston, MA
    3 days ago
  • $100k - $130k

    CPS, Inc. in Boston, Massachusetts is seeking a Principal Specialist of Regulatory Affairs & Compliance. This role demands expertise in regulatory compliance, crisis management, and oversight to ensure product integrity and consumer safety. The successful candidate will... 
    Senior

    CPS, Inc.

    Boston, MA
    2 days ago
  • $118.4k - $148k

    National Geographic is seeking a Senior Manager, Gaming Compliance & Risk in Boston. This role entails overseeing compliance with...  ...relevant experience in gaming compliance, risk management, and regulatory affairs. The position offers a competitive salary range of $118,400... 
    Senior

    National Geographic

    Boston, MA
    5 days ago
  •  ...healthcare technology firm in Boston seeks an Enterprise Client Principal to lead critical enterprise partnerships with major biopharma companies. This senior role oversees strategic accounts, ensuring successful collaboration across scientific, clinical, and commercial... 
    Senior

    Beacon Biosignals

    Boston, MA
    2 days ago
  •  ...lead the development and delivery of high-quality clinical and regulatory documents. This role involves providing scientific leadership...  ...degree in life sciences, and a strong background in clinical development and regulatory submissions. #J-18808-Ljbffr Rbw Consulting
    Senior

    Rbw Consulting

    Boston, MA
    3 days ago
  •  ...Senior CMC Regulatory Submission Manager A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity... 
    Senior

    Careers Integrated Resources Inc

    Lexington, MA
    5 days ago
  • $208.2k - $327.14k

     ...Senior Director, Global Regulatory Lead – Oncology Base pay range: $208,200.00/yr - $327,140.00/yr...  ...manner. Accountable for US FDA submissions and approvals of project(s) of responsibility...  ...broad concepts within regulatory affairs and implications across the... 
    Senior
    Local area
    Remote work
    Worldwide

    Takeda

    Boston, MA
    3 days ago
  • $90 - $130 per hour

     ..., testing, and Premarket Approval (PMA) submission of a Class III long‑term implantable medical...  ..., manufacturing readiness, and regulatory submission activities. The Project Manager...  ...closely with Device Development, Regulatory Affairs, Quality, Manufacturing, and external... 
    Senior
    Contract work

    Ipro Networks Pte. Ltd.

    Cambridge, MA
    2 days ago
  • $100k - $130k

    About This Role The Senior Analyst, Statistical Programming leads and oversees statistical programming activities both internally and...  ...dataset specifications, tables, listings, figures, electronic submission components, and ad hoc analyses. You will partner with Biostatistics... 
    Senior
    Temporary work
    Work experience placement
    Local area

    Biogen

    Cambridge, MA
    4 days ago
  • $196k - $240k

     ...Dyne Tx, located in Waltham, MA, is searching for a Senior Principal Scientist in ADME/PK to lead preclinical strategies for drug...  ..., collaborating with multiple departments, and authoring regulatory submissions. Candidates should have a PhD and over 12 years of relevant... 
    Senior

    Dyne Tx

    Waltham, MA
    2 days ago
  • $222k - $370k

     ...development of appropriate regulatory strategies and...  ...Advocate persuasively to senior leaders in GSK and in Health...  ...in regulatory affairs (10+ years) ~5 + years...  ...development and regulatory submissions. ~ Track record...  ...GSK is a global biopharma company with a purpose... 
    Senior
    Local area

    GlaxoSmithKline

    Waltham, MA
    3 days ago
  • $144.38k - $240.63k

     ...Waltham Posted Date: May 26 2026 Senior Manager - CMC Regulatory Affairs Biopharm Development Projects At...  .../lifecycle maintenance submission content, in accordance with the applicable...  ...disease together. GSK is a global biopharma company with a purpose to unite... 
    Senior
    Local area
    Worldwide

    GSK, Plc.

    Waltham, MA
    2 hours ago
  •  ...When you join Sunrise Senior Living, you will be able to use your unique skills to empower...  ...well-being, quality assurance, and regulatory compliance. Additionally, a key component...  ...Service, the Sunrise Team Credo and the Leaders Serve Hallmarks. Guiding Team Success Build... 
    Senior
    Work at office
    Local area
    Flexible hours
    Shift work
    Weekend work
    Afternoon shift

    Sunrise Senior Living

    Newton, MA
    2 days ago
  • $325k - $400k

     ...healthcare laws. Candidates should hold a J.D., be admitted to the Massachusetts bar, and have 15+ years of legal experience, particularly in biopharma. A competitive salary of $325,000 - $400,000 is offered, along with a hybrid work schedule. #J-18808-Ljbffr Scholar Rock, Inc.

    Scholar Rock, Inc.

    Cambridge, MA
    1 day ago
  • Kinsley Power Systems is seeking a Human Resource Manager in Burlington, MA, to lead key HR strategies and ensure compliance with organizational goals. The role requires at least 10 years of experience, including managerial roles, and a strong understanding of labor regulations...
    Senior

    Kinsley Power Systems

    Burlington, MA
    5 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Regulatory Affairs Leader - Biopharma Submissions. Be the first to apply!