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Part Time Cmc Regulatory Affairs Jobs (NOW HIRING)

BeiGene, Inc.

Intern - Regulatory Affairs, CMC (year-round)

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

The Regulatory Affairs CMC Intern will support regulatory projects consistent with company goals by working closely with the hiring manager and cross-functional team members, including Quality ...

BeiGene USA

Intern - Regulatory Affairs, CMC (year-round)

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

The Regulatory Affairs CMC Intern will support regulatory projects consistent with company goals by working closely with the hiring manager and cross-functional team members, including Quality ...

Harley-Davidson

Sr Regulatory Affairs Engineer

Wauwatosa, WI · On-site

$98K - $135K/yr

  • Medical

  • Retirement

Harley-Davidson Motor Company Full or Part-Time: Full Time Shift: SHIFT1 At Harley-Davidson, we are ... Job Summary The Sr Regulatory Affairs Engineer is responsible for developing and executing ...

US Department of the Air Force

$49K/yr

Skill in applying basic principles, concepts and practices of foreign affairs sufficient to perform ... PART-TIME OR UNPAID EXPERIENCE : Credit will be given for appropriate unpaid and or part-time work.

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Part Time Cmc Regulatory Affairs information

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$15

$34

$145

How much do part time cmc regulatory affairs jobs pay per hour?

As of Aug 16, 2026, the average hourly pay for part time cmc regulatory affairs in the United States is $34.60, according to ZipRecruiter salary data. Most workers in this role earn between $22.36 and $26.20 per hour, depending on experience, location, and employer.

What are the main challenges faced in a part time CMC Regulatory Affairs role, and how can they be managed effectively?

One of the main challenges in a part-time CMC Regulatory Affairs position is balancing the workload and ensuring timely communication with cross-functional teams, given limited working hours. Prioritizing tasks, maintaining clear documentation, and proactively scheduling meetings can help manage these constraints. Additionally, staying updated on regulatory changes and maintaining strong relationships with both internal stakeholders and external regulatory agencies are crucial for success. Effective time management and a collaborative mindset are key to overcoming these challenges while delivering high-quality regulatory submissions.

What is a part time CMC Regulatory Affairs?

Part Time CMC Regulatory Affairs jobs involve ensuring that a pharmaceutical or biotechnology company's Chemistry, Manufacturing, and Controls (CMC) documentation meets regulatory requirements, but on a part-time basis. Professionals in these roles prepare, review, and submit CMC sections of regulatory filings such as INDs, NDAs, and MAAs. They work closely with manufacturing, quality, and development teams to ensure compliance with global regulations, while balancing flexible or reduced work hours. This is ideal for those seeking work-life balance or supplementing other commitments.

What is the difference between Part Time Cmc Regulatory Affairs vs Part Time Regulatory Affairs Specialist?

AspectPart Time Cmc Regulatory AffairsPart Time Regulatory Affairs Specialist
CredentialsTypically requires a degree in life sciences, pharmacy, or related field; certifications like RAC are a plusSimilar credentials; often holds degrees in sciences and certifications like RAC or RA
Work EnvironmentFocuses on chemistry, manufacturing, and control (CMC) documentation for drug approval processesBroader regulatory tasks including submissions, compliance, and communication with authorities
Employer & Industry UsagePrimarily in pharmaceutical and biotech companies, especially in manufacturing and quality departmentsUsed across pharmaceutical, biotech, and medical device companies in regulatory departments

While both roles involve regulatory knowledge, Part Time Cmc Regulatory Affairs specializes in CMC documentation for drug approval, whereas Part Time Regulatory Affairs Specialist covers a broader range of regulatory tasks. The choice depends on your focus area within regulatory affairs.

What are the key skills and qualifications needed to thrive as a part time CMC Regulatory Affairs professional?

To thrive as a Part Time CMC Regulatory Affairs professional, you need a solid understanding of chemistry, manufacturing, and controls (CMC) regulations, along with a degree in life sciences or a related field. Familiarity with regulatory submission systems, document management tools, and knowledge of global regulatory guidelines such as FDA, EMA, and ICH is essential. Strong attention to detail, organizational skills, and clear communication are vital soft skills for success in this role. These competencies ensure regulatory compliance, efficient documentation, and successful product approvals in a highly regulated industry.
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Part Time Cmc Regulatory Affairs jobs near you
Infographic showing various Part Time Cmc Regulatory Affairs job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 87% Full Time, 9% Part Time, and 3% Contract. Highlights an 90% Physical, 4% Hybrid, and 6% Remote job distribution, with an average salary of $71,960 per year, or $34.6 per hour.

Intern - Regulatory Affairs, CMC (year-round)

BeiGene, Inc.

Remote

Part-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 13 days ago

Job description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description/Scope of Responsibilities (Internship):
BeOne is seeking a motivated and talented individual to join our Reg CMC small molecule team which offers meaningful project experiences that gives interns the opportunity to gain valuable Biotech experience as they complete their academic journey.
The Regulatory Affairs CMC Intern will support regulatory projects consistent with company goals by working closely with the hiring manager and cross-functional team members, including Quality Assurance, Supply Chain, CMC, and IT. The focus of the internship is for the intern to develop a deeper understanding of the drug development process and regulatory requirements in a professional work environment, while contributing to process optimization in knowledge management. Specifically, the intern will:
  • Be exposed to the broad scope of global Regulatory Affairs and specifically CMC Regulatory Affairs and the role's contribution to drug development and patients' access to medicines.
  • Learn about the role of global Health Authorities in the drug development process.
  • Gain hands-on experience in preparing regulatory documents for submission to global health authorities.
  • Acquire knowledge about the differences in regulatory requirements across regions.
  • Experience CMC technical product development and manufacturing functions in relation to regulatory affairs.

Essential Functions of the Internship:
  • Responsible for maintaining accurate CMC information in the BeOne Regulatory Information Management system
  • Data remediation
  • Create and maintain CMC Submission Content
  • Upload HA Correspondence/HA Questions/Commitments
  • Maintain internal Regulatory CMC trackers
  • Contribute to Reg CMC process improvements
  • Support the drafting of CTD CMC sections to ensure on-time and high-quality global applications for direct submission to Health Authorities as needed.
  • Provide support to Reg CMC team or hiring manager with Regulatory submissions and other tasks as needed

Supervisory Responsibilities:
  • No

Computer Skills: Proficient in Microsoft Office
Education Required: Active enrollment (Graduate or Ph.D.) in an accredited college or university pursing a degree in a scientific discipline (e.g., life sciences, chemistry, biology, biotechnology, materials science, etc.) with a minimum 3.0 GPA
Other Qualifications:
  • Awareness of processes for working in a regulated field preferred
  • Basic knowledge of healthcare industry and strong passion for biotech
  • Legally authorized to work in the United States without needing sponsorship for employment now or in the future
  • Ability to work independently on assignments with routine check-ins
  • Strong written and oral communication skills
  • Organized, responsible, resourceful, and detail-oriented
  • Able to work in a cross-cultural team environment with members across different time zones
  • Able to work remotely using MS TEAMS and other collaboration tools

Travel: None
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative
  • Entrepreneurial Mindset
  • Continuous Learning
  • Embraces Change
  • Results-Oriented
  • Analytical Thinking/Data Analysis
  • Financial Excellence
  • Communicates with Clarity

Salary Range: $ - $ per hour
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.
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About BeiGene

Sourced by ZipRecruiter

BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235) is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of over 8,200 colleagues across five continents. For more information, please visit www.beigene.com .

Industry

Health care and social assistance

Company size

5,001 - 10,000 Employees

Headquarters location

Cambridge, MA, US

Year founded

2010

Social media

Twitter

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