Top 278 Regulatory cmc Jobs in Boston, Ma

Director, Regulatory CMC
Rhythm Pharmaceuticals —Boston, MA
- $182,000 - $275,000 a year
- Full-time
- Bachelor of Science
- Office
- Bachelor's degree
Associate/Sr. Associate - CMC Project Management & Operations
Oruka Therapeutics —Waltham, MA
- $104,000 - $146,000 a year
- Hybrid work
- Mid-level
- Office
- Bachelor's degree
Quick Apply
Director/ Senior Director, Regulatory CMC
Vor Bio —Boston, MA
- $200,000 - $265,000 a year
- Doctor of Philosophy
- Manufacturing
- Senior level
- Health insurance
- 401(k)
CMC Analytical Research & Development Scientist
Warwick Consulting —Lexington, MA
- $120,000 - $150,000 a year
- Full-time
- Bachelor of Science
- Mid-level
- 3 years
- Health savings account
- Health insurance
Quick Apply
9d
Manager, Regional Regulatory Lead - LCM
CSL —Waltham, MA
- $129,000 - $153,000 a year
- Full-time
- Hybrid work
- 3 years
- Bachelor's degree
- Doctor of Philosophy
Sr. Engineer - Process Development
Yoh, A Day & Zimmermann Company —Waltham, MA
- $33.60 - $48.00 an hour
- Contract
- Master's degree
- Bachelor's degree
- Continuous improvement
- Health savings account
- Disability insurance
Quick Apply
Associate Director of Business Development - Southern West Coast (Biotech Services)
Coriolis Pharma Research GmbH —Boston, MA
- Up to 50% travel
- Customer service
- 5 years
Quick Apply
Associate Director, Global Regulatory, CMC
Moderna, Inc. —Norwood, MA
- $142,500 - $256,500 a year
- Full-time
- 5 years
- Bachelor of Science
- Office
- Paid time off
- Adoption assistance
Associate Manager CMC Regulatory Compliance
Merck KGaA —Billerica, MA
- $77,800 - $116,700 a year
- Hybrid work
- Office
- Master's degree
- Bachelor's degree
- Health insurance
- Paid time off
Analyst
Locust Walk —Boston, MA
- Full-time
- Hybrid work
- Mid-level
- Presentation skills
- 1 year
- Health insurance
- Dental insurance
Quick Apply
Associate Director, Regulatory Affairs CMC
CRISPR Therapeutics, Inc. —South Boston, MA
- $165,000 - $180,000 a year
- Full-time
- Writing skills
- Bachelor's degree
- Doctor of Philosophy
Quick Apply
Manager, Regulatory Affairs
Monte Rosa Therapeutics, Inc —Boston, MA
- $120,000 - $140,000 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Research
Manager, Commercial Supply Chain
Agios Pharmaceuticals —Cambridge, MA
- $110,029 - $165,044 a year
- Remote
- 5 years
- Bachelor of Science
- Engineering
- Health insurance
Associate Director, Regulatory CMC (Biologics)
Oruka Therapeutics —Waltham, MA
- $181,000 - $208,000 a year
- Hybrid work
- Office
- 3 years
- Master's degree
Senior Manager, Global Regulatory Affairs CMC
Merck KGaA —Billerica, MA
- $134,200 - $202,200 a year
- Hybrid work
- 7 years
- Office
- Doctor of Philosophy
- Health insurance
- Paid time off
Director/Sr. Director Regulatory CMC, Lilly Regenerative Medicine
Eli Lilly —Boston, MA
- $163,500 - $281,600 a year
- Full-time
- 5 years
- Bachelor's degree
- Continuous improvement
- Health insurance
- Dental insurance
Associate Manager, CMC Operations
CRISPR Therapeutics, Inc. —South Boston, MA
- $110,000 - $120,000 a year
- Full-time
- Analysis skills
- Senior level
- Communication skills
Quick Apply
12d
Associate Director, Quality Operations
Amylyx Pharmaceuticals —Cambridge, MA
- $172,000 - $194,000 a year
- 8 years
- Bachelor's degree
- Travel
Associate Director, Regulatory CMC, Biologics
Vertex Pharmaceuticals —Boston, MA
- $166,400 - $249,600 a year
- Full-time
- Hybrid work
- Management
- 8 years
- Bachelor's degree
- Loan repayment program
- Health insurance
Director / Senior Director, Regulatory CMC (Biologics)
Oruka Therapeutics —Waltham, MA
- $213,000 - $286,000 a year
- Hybrid work
- 5 years
- Office
- Doctor of Philosophy

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Director, Regulatory CMC

Rhythm Pharmaceuticals
Boston, MA

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Job Details

Full-time
$182,000 - $275,000 a year

Benefits

Qualifications

Bachelor's degree
Pharmaceutical company experience

Full Job Description

Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.

Opportunity Overview
This role is responsible for executing high-quality, science-based, and compliant regulatory CMC deliverables for assigned program(s), in alignment with strategies established by Global Regulatory Affairs and Technical Operations.

This individual contributor role will execute regulatory CMC plans and support implementation of filing strategies for assigned programs. As part of the growing and dynamic regulatory affairs team, this role is accountable for the effective management and timely delivery of CMC regulatory documents, coordination of cross-functional inputs, and support of regulatory CMC execution activities across development, commercialization, and lifecycle management. The role will work closely with Global Regulatory Affairs, Technical Operations, Quality, and other internal stakeholders to ensure deliverables are aligned, complete, and compliant with global regulatory requirements and commitments.

Responsibilities and Duties

Serve as the regulatory CMC representative on cross-functional teams for assigned programs and execute deliverables in alignment with strategies established by Global Regulatory Affairs and Technical Operations.
Author, compile, review, and finalize high-quality CMC regulatory documents and submissions, including core dossiers, INDs, IMPDs, MAAs, BLAs, variations, and annual reports, in collaboration with internal and external stakeholders.
Coordinate and support the timely execution of regulatory filings and submission activities in compliance with applicable global regulatory requirements, commitments, and internal timelines.
Prepare regulatory CMC meeting requests, briefing materials, and supporting documentation to enable effective health authority interactions and internal governance reviews.
Assess CMC change controls to determine regulatory impact, identify filing requirements across regions, evaluate supporting documentation, and escalate risks or gaps as appropriate.
Track regulatory commitments, health authority questions, and submission-related action items, and coordinate cross-functional responses within agreed timelines.
Maintain current knowledge of relevant CMC regulations, guidance, and regional expectations, and communicate executional impact to internal stakeholders.
Contribute to continuous improvement of regulatory processes, templates, SOPs, and systems that support efficient and compliant document development and submission execution.

Qualifications and Skills

A minimum of a B.S. degree in a scientific or life sciences discipline with a minimum of 10 years experience in Regulatory CMC, manufacturing, analytical development, quality, or related pharmaceutical development environments.
Demonstrated experience supporting regulatory programs for products intended to treat rare diseases and/or conditions with high unmet medical need is preferred.
Experience preparing CMC documentation to support clinical trial applications, marketing applications, post-approval submissions, and health authority responses.
Experience with peptides and injectable dosage forms and/or injection drug delivery devices is required.
Strong execution skills with demonstrated ability to manage multiple deliverables, coordinate cross-functional input, and deliver high-quality work within aggressive timelines.
Working knowledge of global CMC regulatory requirements, guidelines, and expectations across development, registration, and lifecycle management in multiple ICH regions.
Ability to work independently within established strategic direction, identify issues proactively, and escalate risks appropriately.
Strong organizational, planning, communication, and collaboration skills, with the ability to work effectively across Global Regulatory Affairs, Technical Operations, Quality, and external partners.

This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.

The expected salary range for this position is $182,000 - $275,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.

More about Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.

At Rhythm our core values are:

We are committed to advancing scientific understanding to improve patients’ lives
We are inspired to tackle tough challenges and have the courage to ask bold questions
We are eager to learn and adapt
We believe collaboration and ownership are foundational for our success
We value the unique contribution each individual brings to furthering our mission

Inherent in our core values is the commitment to act ethically and with integrity in all we do.

Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.

Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.

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Refine Your Search

regulatory cmc jobs in boston, ma

Director, Regulatory CMC

Associate/Sr. Associate - CMC Project Management & Operations

Director/ Senior Director, Regulatory CMC

CMC Analytical Research & Development Scientist

Manager, Regional Regulatory Lead - LCM

Sr. Engineer - Process Development

Associate Director of Business Development - Southern West Coast (Biotech Services)

Associate Director, Global Regulatory, CMC

Associate Manager CMC Regulatory Compliance

Analyst

Associate Director, Regulatory Affairs CMC

Manager, Regulatory Affairs

Manager, Commercial Supply Chain

Associate Director, Regulatory CMC (Biologics)

Senior Manager, Global Regulatory Affairs CMC

Director/Sr. Director Regulatory CMC, Lilly Regenerative Medicine

Associate Manager, CMC Operations

Associate Director, Quality Operations

Associate Director, Regulatory CMC, Biologics

Director / Senior Director, Regulatory CMC (Biologics)

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