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Entry Level Regulatory Affairs Cmc Jobs (NOW HIRING)

Abbott

Regulatory Affairs Associate

South Portland, ME · On-site

$19 - $21/hr

Regulatory Affairs Associate Location: South Portland, ME Duration: 12 Months Shifts: 8AM TO 4:30PM ... CMC). * Ensures timely approval of new medical devices and continued approval of marketed products.

Watton Hall

CMC Specialist

CMC Specialist The CMC Specialist in Regulatory Affairs is responsible for overseeing the Chemistry, Manufacturing, and Controls (CMC) aspects of regulatory submissions for pharmaceutical products.

Bimeda Inc.

Regulatory Affairs Associate

Houston, TX · On-site

The Regulatory Affairs Associate builds and maintains strong relationships with colleagues in ... CMC submissions * Labeling supplements * Correspondence with regulatory agencies * Maintain ...

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Entry Level Regulatory Affairs Cmc information

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$15

$34

$145

How much do entry level regulatory affairs cmc jobs pay per hour?

As of Aug 14, 2026, the average hourly pay for entry level regulatory affairs cmc 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 is the difference between Entry Level Regulatory Affairs Cmc vs Entry Level Regulatory Affairs?

AspectEntry Level Regulatory Affairs CmcEntry Level Regulatory Affairs
Required CredentialsBachelor's degree in life sciences, pharmacy, or related field; knowledge of CMC regulationsBachelor's degree in life sciences, pharmacy, or related field; understanding of regulatory processes
Work EnvironmentPharmaceutical or biotech companies, focusing on CMC documentation and complianceRegulatory departments across various industries, handling submissions and compliance
Employer & Industry UsagePrimarily in pharma/biotech with a focus on CMC aspectsBroader industry use, including healthcare, biotech, and pharma

Entry Level Regulatory Affairs Cmc roles focus specifically on Chemistry, Manufacturing, and Controls documentation, requiring specialized knowledge of CMC regulations. In contrast, Entry Level Regulatory Affairs roles have a broader scope, covering overall regulatory submissions and compliance across industries. Both roles typically require similar educational backgrounds but differ in technical focus and daily responsibilities.

What does an entry level regulatory affairs CMC do?

As an Entry Level Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls) professional, your daily tasks often include preparing and reviewing CMC documentation for regulatory submissions, assisting in compiling data to meet regulatory requirements, and maintaining records related to product quality and compliance. You’ll also collaborate closely with cross-functional teams such as quality assurance, manufacturing, and research and development to gather necessary information and ensure alignment with regulatory standards. Attention to detail and strong organizational skills are essential, as the work involves managing multiple projects and strict timelines.

What skills and qualifications are needed to thrive as an entry level regulatory affairs CMC?

To thrive as an Entry Level Regulatory Affairs CMC professional, you generally need a background in life sciences or pharmacy, strong analytical skills, and an understanding of regulatory guidelines. Familiarity with regulatory submission systems, document management tools, and knowledge of ICH, FDA, and EMA regulations are typically important. Attention to detail, strong organizational skills, and effective written communication help you stand out in this role. These competencies ensure accurate and compliant submissions, facilitating successful product approvals and efficient collaboration within cross-functional teams.

What is an entry level regulatory affairs CMC?

Entry Level Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls) roles are positions within the pharmaceutical, biotechnology, or medical device industries that focus on ensuring products meet regulatory requirements related to their manufacturing and quality. Professionals in these positions help prepare and submit documentation to regulatory agencies, support compliance with global regulations, and collaborate with teams to address product changes or updates. Entry-level roles are ideal for recent graduates or those new to regulatory affairs, providing foundational experience in regulatory submissions, document review, and regulatory strategy for product development and lifecycle management.
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Entry Level Regulatory Affairs Cmc jobs near you
Infographic showing various Entry Level Regulatory Affairs Cmc 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.

Regulatory Affairs CMC Associate

Fladger Associates

Foster City, CA • On-site

Contractor

Re-posted 4 days ago

Job description

Foster City, CA
Contract Duration: 6-18 months
Rate: Negotiable

Responsibilities:

  • Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area candidates ONLY
  • Provide Regulatory CMC support for biologic and small molecule drugs being evaluated or marketed for the treatment of oncology, HIV and liver disease.
  • The Associate, working with the project team and regional regulatory leads in the US, EU and other countries, will support documentation for submission to regulatory authorities.
  • May serve as regional lead on cross-functional/ cross-regional Regulatory Submission Teams.
  • May participate on other Subteams, as applicable.
  • Responsible for preparing and submitting regulatory documents which require interaction with departments in and outside of Regulatory Affairs CMC for investigational and commercial biologics and small molecule products, in line with ICH requirements, regional requirements and scientific and company policies and procedures.
  • Examples include original INDs, NDAs, BLAs, amendments, supplements, annual reports and license renewals.
  • Performs document filing and retrieval functions as directed, or in conjunction with departmental SOPs and work instructions.
  • Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory Department.
  • Provides input to senior Regulatory Affairs CMC professionals in the preparation of country specific labeling and for ensuring product packaging and associated information is updated and maintained in accordance with the product license as applicable.
  • Maintains knowledge of regulatory requirements and communicates changes in regulatory information to line manager and regulatory project teams in a timely manner.
  • Work cooperatively with regional regulatory sites to support the accurate and timely communication of critical information.
  • Provide support for cGMP activities as they relate to Regulatory Affairs CMC`.
  • Work is performed cross-functionally within a matrixed organization under supervision of senior Regulatory Affairs CMC professionals and line manager.

Experience:

  • BS/BA Degree in Scientific field preferred and 2 years of relevant Pharmaceutical/Biotech industry experience, for example in Regulatory Affairs CMC.
  • Excellent organizational skills and ability to work on multiple projects with tight timelines is required.
  • Excellent verbal and written communication skills and interpersonal skills are expected.
  • Must work well under demanding deadlines and have excellent attention to detail.
  • Must have a reasonable understanding of regulatory requirements, including ICH requirements and US regional requirements