Waltham, Massachusetts, United States · Hybrid
$181k–$208k/yr
About Us: Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseas…
Skills: Regulatory CMC Strategy, Biologics Development, IND/IMPD/BLA Authoring, Combination Product Regulations, cGMP
Waltham, Massachusetts, United States · Hybrid
$89k–$100k/yr
Senior Accountant We are seeking a detail-oriented and analytical Senior Accountant to join our finance team. This role is a critical intersection of technical accounting, operational efficiency, and cross-functional col…
Skills: Revenue Recognition, Gross-to-Net Accounting, SOX Compliance, SEC Reporting, GAAP
Waltham, Massachusetts, United States · Hybrid
$185k–$197k/yr
Reporting to the Senior Director, Regulatory Affairs, Advertising, Promotion & Labeling, the Associate Director, Regulatory Affairs, Advertising and Promotion will be responsible for providing sound regulatory advice rel…
Skills: FDA Laws And Regulations, Regulatory Advertising And Promotion Review, Clinical Trial Design, Clinical Data Interpretation, Interpersonal Skills
Waltham, Massachusetts, United States · On-site
$182k–$346k/yr
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a r…
Skills: Clinical Trial Design, Clinical Development Planning, Regulatory Compliance, Pharmacovigilance, Good Clinical Practices
Waltham, Massachusetts, United States · Hybrid
$167k–$182k/yr
This position is an integral part of the CQA team and provides oversight for and participates in, auditing services in support of Alkermes Clinical Programs by conducting clinical site, vendor qualification, internal sys…
Skills: Clinical Auditing, cGCP Compliance, GLP Compliance, Vendor Qualification, Internal Systems Auditing
Waltham, Massachusetts, United States · Hybrid
$161k–$305k/yr
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a r…
Skills: Legal Strategy, Regulatory Compliance, Risk Assessment, Pharmaceutical Law, FDA Regulations
Waltham, Massachusetts, United States · Hybrid
$161k–$305k/yr
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a r…
Skills: Legal Strategy, Regulatory Compliance, Risk Assessment, Pharmaceutical Law, FDA Regulations
Waltham, Massachusetts, United States · On-site
$180k–$220k/yr
Company Description Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates …
Skills: Account Management, Stakeholder Management, Clinical Acumen, Rare Disease Market Knowledge, Buy-and-Bill
Waltham, Massachusetts, United States · On-site
This is an open and continuous posting for full-time and part-time positions on multiple shifts serving the Group Homes throughout the Metro Region of DDS. The Department of Developmental Services (DDS) seeks compassiona…
Skills: Nursing Care, Medication Administration, Vital Signs Charting, Wound Care, CPR
Waltham, Massachusetts, United States · On-site
$28/hr–$32/hr
Full time, 40 hours per week position. Specific schedule TBD by department needs. THE POSITION: The Client Services Supervisor provides supervision and training of the front office staff members (Client Care Specialists)…
Skills: Supervision, Training, Client Service, Payroll Processing, Personnel Management
Waltham, Massachusetts, United States · Hybrid
$195k–$230k/yr
Who We Are: Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs. Cogent’s lead program, bezuclastinib,…
Skills: Patient Marketing, Omnichannel Strategy, Digital Marketing, Rare Disease Expertise, Oncology Marketing
Waltham, Massachusetts, United States · Remote OK
Job Description A bit more about this role: This position represents an amazing opportunity for a caring nurse practitioner (APRN). Your primary focus will be delivering world class comprehensive care to our members. One…
Skills: Telehealth, Primary Care, Comprehensive Assessment Visits, Disease Review, Medication Review
Waltham, Massachusetts, United States · Remote OK
$150k–$250k/yr
About Us Would you like to be part of a fast-growing team that believes no one should have to succumb to cancer? Naveris, a commercial stage precision oncology company based near Boston, MA, is looking for a Sales Repres…
Skills: Consultative Selling, Account Growth, Business Planning, CRM Utilization, Data Analysis
Waltham, Massachusetts, United States · On-site
$135k–$203k/yr
Job title: Translational Science, Associate Director Location: Boston, MA. Are you a visionary expert in translational science, with the ability to execute a successful strategy in accelerating the development of therapi…
Skills: Translational Science, Biomarker Strategy, Immunology, Clinical Development, CRO Management
Waltham, Massachusetts, United States · Hybrid
$145k–$177k/yr
Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-drive…
Skills: Computer Systems Validation, IT Compliance, Risk Management, GxP, FDA Regulatory Compliance
Waltham, Massachusetts, United States · On-site
$158k–$180k/yr
CSL's organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosyste…
Skills: Molecular Biology, RNA Therapeutics, Gene Editing, Gene Therapy, Next-Generation Sequencing
Waltham, Massachusetts, United States · On-site
$18/hr–$26/hr
Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As …
Skills: Medical Terminology, Attention To Detail, Communication, Interpersonal Skills, Teamwork
Waltham, Massachusetts, United States · On-site
$18/hr–$26/hr
Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As …
Skills: Medical terminology, Attention to detail, Communication, Interpersonal skills, Teamwork
Waltham, Massachusetts, United States · On-site
$181k–$272k/yr
The Translational Medicine (TM) Early Data Science (EDS) group delivers data-driven, actionable insights through the application of computational science to AstraZeneca's Oncology portfolio. The group has substantial exp…
Skills: Computational Biology, Bioinformatics, Immuno-Oncology, Multi-omics, AI/ML
Waltham, Massachusetts, United States · Remote OK
$122k–$205k/yr
PURPOSE AND SCOPE: Responsible for designing, implementing, operating, and securing network infrastructure across public cloud environments (e.g., Azure, AWS, GCP) and hybrid architectures. This role partners closely wit…
Skills: Azure, AWS, GCP, TCP/IP, DNS
Waltham, Massachusetts, United States • Hybrid
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Develop and execute regulatory CMC strategies and author high-quality dossiers for global submissions including IND, IMPD, and BLA. Act as the primary SME for CMC in cross-functional meetings and manage interactions with global regulatory agencies.
Requires a Master's or PhD in life sciences with 6-8 years of CMC experience and at least 3 years specifically in biologics regulatory CMC. Must have a proven track record with FDA/EMA submissions and expertise in combination drug/device regulations.
About Us:
Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com
As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.
Job Title: Associate Director, Regulatory CMC (Biologics)
Location: Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week.
We are seeking an experienced and motivated candidate to develop regulatory CMC strategy in support of early-to-late-stage clinical programs. In this role, you will be responsible for authoring high quality regulatory CMC submission while guiding CMC teams on relevant phase appropriate global regulatory guidelines. You are an ideal candidate for this role if you have experience in biologics development and manufacturing with significant exposure to regulatory CMC submissions. In this role, you will have the opportunity to foster strong collaboration, communication, and problem solving to meet key program and corporate objectives. This is a highly visible role and a pivotal addition to our growing organization where you will play an integral role in supporting multiple campaigns in support of a fast-growing biologics pipeline.
We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.
Novel biologics that aim to offer freedom from disease to people with plaque psoriasis and other associated conditions
Advancing novel biologics that aim to offer the greatest possible freedom from disease to people with plaque psoriasis and other associated conditions
Based on 409 listings with disclosed salaries, most healthcare jobs in Waltham, MA pay between $43k–$235k per year. Individual offers vary with seniority, company size, and specialization.
There are currently 501 open healthcare positions in Waltham, MA listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include Devoted Health, Fresenius Medical Care, Allergan, Alkermes, Dyne Therapeutics, among others. Browse the listings above to see every active employer.
Yes — 199 of the 501 open healthcare positions offer remote or hybrid work (85 remote, 114 hybrid).
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.
