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New · posted Oct 14

Regeneron · Biotechnology

Assoc CMC Regulatory Sciences Specialist

  • United States
  • On-site
  • Full-time
  • Associate & Specialist
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EmploymentFull-time
Deadline

Open until filled

The role

Summary: Responsible for providing Chemistry, Manufacturing, and Controls (CMC) support across Regeneron’s sites. Routine activities include dossier development for clinical trial applications, marketing applications, amendments, post approval variations and other regulatory submissions.

Essential Duties and Responsibilities include, but are not limited to, the following:

· Prepares global CMC documents and sections for a variety of clinical and commercial biopharmaceutical regulatory submissions, ensuring that all submissions are complete, accurate and meet relevant requirements.

· Manages and coordinates the authoring, review and finalization of CMC documents and responses to CMC-related inquiries from Regulatory agencies, in accordance with submission timelines, keeping all stakeholders, including external partners, informed of progress.

· Collaborates and develops excellent relationships with functional area and cross functional teams, contract manufacturing organizations and global Regulatory partners.

· Applies in-depth understanding of regulatory guidance and regulations, as well as industry and government agency best practices and trends.

· May review relevant CMC documents and reports for completeness, accuracy and compliance with regulations and regulatory guidance.

· May proactively identify issues and contributes to the development of appropriate strategies to mitigate risk.

· May assist in preparation for meetings with global regulatory authorities.

· May contribute to developing CMC regulatory strategy.

· May review regulatory submission documents to ensure that all submissions are complete, accurate and meet relevant requirements.

· May oversee and assign projects to other specialists; may have direct reports.

What you need

· Associate Specialist: Requires BA/BS degree or equivalent combination of education and experience.

· Specialist: Requires BA/BS degree and 2 years of relevant experience or equivalent combination of education and experience.

· Senior Specialist: Requires BA/BS degree and 5 years of relevant experience or equivalent combination of education and experience.

· Degree in a scientific field preferred.

· Advanced degree preferred.

Knowledge, Skills and Abilities:

· Excellent written and verbal communication skills.

· Ability to work independently, prioritize, coordinate and complete multiple projects within deadline while maintaining a high level of attention to detail.

· Knowledge of relevant drug development regulations and guidelines (i.e. FDA regulations and ICH guidelines) as well as an understanding of CGMPs (Current Good Manufacturing Practices).

· Strong skills in planning, critical thinking and problem-solving.

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Pay and benefits

$62,355 – $92,400 a year

Employer provided
How this compares

$62,355.00 - $92,400.00

  • Annual bonuses or incentive plans

  • Equity awards

  • 401(k) company match

  • Health and wellness programs

  • Medical, dental, vision, life and disability insurance

  • Paid time off

Where you'll work

United StatesOn-siteOpen in Maps (opens in a new tab)

Equal opportunity, accessibility and legal noticesRegeneron's statements, word for word

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all  qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Job intelligence

The context around this role

Live data · October 14, 2026

Salary intelligence

How the pay compares

This role's midpoint is level with the US median for Regulatory CMC roles at this level.

This roleEmployer provided

$62,355 to $92,400 a year

Associate & Specialist roles in the US7 roles publishing pay

Middle half $77,000 to $77,500, median $77,000
Annual base pay
Annual base payLowMedianHigh
This role$62,355—$92,400
All US$77,000$77,000$77,500

This role: Regeneron's own published range. Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, October 14, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Regulatory CMC

The general path across 53 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not Regeneron's own promotion track.

  1. This role

    Associate & Specialist

    Often: Intern · Associate CMC Regulatory Sciences Data Analyst

    $77K median8 open
  2. Next step

    Senior & Principal

    Often: Advisor/Sr. Advisor · Global Regulatory CMC Lead

    $151K median9 open
  3. Later

    Manager

    Often: Manager, Regulatory Affairs CMC · Sr Manager, Regulatory Affairs CMC

    $168K median9 open
  4. Later

    Director

    Often: Director, Global Regulatory Affairs · Director, Global Regulatory Affairs CMC

    $208K median24 open
  5. Later

    VP & Executive

    Often: Global Head of Technical Regulatory & Quality · Head of CMC Regulatory Affairs

Skills DNA

What this role leans on

How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 3 linesDocumentation and SOPs: 5 linesRegulatory submissions: 6 linesCollaboration and leadership: 4 linesGMPDocumentationSubmissionsTeamwork
  • Regulatory submissions6
  • Documentation and SOPs5
  • Collaboration and leadership4
  • GMP and compliance3

Company hiring pulse

Regeneron on Regulatory Jobs

49
Open roles
44
Distinct roles
9
Locations

By discipline

  • Quality33 67%
  • Regulatory13 27%
  • Compliance & Safety3 6%

By level

  • Associate & Specialist24 49%
  • Manager13 27%
  • Director7 14%
See all 49 Regeneron roles

More roles at Regeneron

All 49 Regeneron roles

Similar Regulatory CMC roles elsewhere

Assoc CMC Regulatory Sciences Specialist at Regeneron

Open until filled. $62K–$92K a year, employer provided.

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    Assoc CMC Regulatory Sciences Specialist at Regeneron — United States | Regulatory Jobs