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
- ...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...SeniorWork at office3 days per week
$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...SeniorRemote job$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...SeniorLocal area3 days per week$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- ...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
$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...SeniorFlexible hours- ...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...SeniorWork at office
- ...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...SeniorRemote work
- ...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
- ...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...SeniorRemote work
$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- ...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...SeniorFlexible hours
$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$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- ...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
$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$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$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- ...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
- ...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 ConsultingSenior
- ...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
$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...SeniorLocal areaRemote workWorldwide$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...SeniorContract work$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...SeniorTemporary workWork experience placementLocal area$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$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...SeniorLocal area$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...SeniorLocal areaWorldwide- ...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...SeniorWork at officeLocal areaFlexible hoursShift workWeekend workAfternoon shift
$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.- 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
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