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New · posted Oct 20

Celldex Therapeutics · Biotechnology

Senior Director, Regulatory Science and CMC Development Strategy

  • Needham, MA
  • On-site
  • Full-time
  • Director
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Pay$203K–$264Ka year · employer provided
EmploymentFull-time
LocationNeedham, MAOn-site
LevelDirector
FunctionRegulatory CMCRegulatory
Deadline

Closes Oct 23, 2026 · 3 days left

The role

The Senior Director, Regulatory Science and CMC Development Strategy is a senior Regulatory Affairs leader responsible for early-stage CMC regulatory strategy and for providing broad regulatory science expertise across the Celldex portfolio. Reporting to the Vice President, Regulatory Affairs, this individual supports advancement of products from IND through late-stage development and serves as a senior advisor on complex issues spanning Clinical, CMC, Quality, Manufacturing, and Regulatory functions.

The Senior Director partners closely with the Regulatory CMC lead, Manufacturing, and Quality to strengthen development-phase CMC strategy, GMP compliance, inspection readiness, and site training capabilities. The role also contributes to major Health Authority interactions, regulatory risk assessments, cross-functional strategic initiatives, and development of Regulatory Affairs capabilities.

What you need

  • Advanced scientific degree (PhD, PharmD, MD, MS, or equivalent) in a relevant scientific discipline.
  • Extensive progressive Regulatory Affairs or regulatory science experience within the biotechnology or pharmaceutical industry, including substantial CMC experience supporting clinical-stage development.
  • Demonstrated experience developing phase-appropriate CMC regulatory strategies and supporting products from IND through later-stage development.
  • Experience supporting FDA and/or global Health Authority interactions, briefing documents, regulatory risk assessments, and responses to technical questions.
  • Working knowledge of GMP expectations, manufacturing and quality systems, and inspection-readiness principles.
  • Demonstrated ability to advise senior leaders, influence cross-functional teams, communicate complex scientific issues clearly, and mentor colleagues.

Preferrednice to have

  • Experience with biologics, monoclonal antibodies, combination products, or manufacturing-site regulatory readiness.
  • Experience designing or delivering GMP and regulatory training for manufacturing or Quality personnel.
  • Experience spanning multiple regulatory disciplines, such as Clinical, CMC, Quality, regulatory intelligence, policy, or commercial-stage support.
  • Experience working in a small or growing biotechnology company and supporting multiple programs or high-priority strategic initiatives.

Skills named in this posting

What you'll do

CMC Development Strategy

  1. Lead regulatory strategy for early-stage CMC development activities and support advancement of products from IND through late-stage development.
  2. Develop phase-appropriate CMC regulatory strategies that align manufacturing development activities, regulatory requirements, program objectives, and planned clinical progression.
  3. Partner with the Regulatory CMC lead to ensure continuity and alignment between early development, registration-stage, and commercial CMC strategies.
  4. Identify CMC regulatory risks, data gaps, dependencies, and mitigation options and communicate recommendations to Regulatory Affairs leadership and cross-functional teams.
  5. Support preparation and review of CMC content for INDs, CTAs, briefing packages, technical responses, and other development-stage regulatory submissions.

Manufacturing, Quality, and Site Readiness

  1. Partner with Manufacturing and Quality to strengthen GMP compliance, inspection readiness, and manufacturing-site training initiatives.
  2. Provide regulatory perspective on development-phase manufacturing, quality, validation, comparability, and facility-readiness topics, in coordination with the accountable Regulatory CMC lead.
  3. Develop and deliver regulatory and GMP-focused training as requested to help site personnel understand Health Authority expectations and the connection between site practices and regulatory commitments.
  4. Support preparation for Health Authority inspections and readiness as requested by identifying regulatory risks, clarifying expectations, and helping teams address gaps.

Regulatory Science and Health Authority Support

  1. Provide regulatory science expertise supporting Health Authority interactions, regulatory risk assessments, and development of regulatory strategy across the portfolio.
  2. Support major regulatory milestones and Health Authority interactions through issue assessment, precedent analysis, briefing document input, meeting preparation, and strategic advice.
  3. Evaluate evolving regulations, guidance, policy, and regulatory precedents and translate relevant implications into practical recommendations for Celldex programs.
  4. Serve as a senior advisor on complex regulatory issues spanning Clinical, CMC, Quality, Manufacturing, and Commercial functions.
  5. Contribute to development of Regulatory Affairs capabilities through mentoring, training, and sharing of regulatory science expertise across the organization.

Pay and benefits

$203,157 – $263,841 a year

Employer provided
How this compares

  • Annual discretionary bonus

  • Long-term incentive

  • 401(k) with employer contribution

  • Health care and insurance benefits

  • Paid holidays

  • Vacation and sick days

Where you'll work

Needham, MAOn-siteOpen in Maps (opens in a new tab)

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Equal opportunity, accessibility and legal noticesCelldex Therapeutics's statements, word for word

The expected base salary for this position is: $203157.00 to $263841.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.

Job intelligence

The context around this role

Live data · October 20, 2026

Salary intelligence

How the pay compares

This role's midpoint is 9% above the US median for Regulatory CMC roles at this level.

This roleEmployer provided

$203,157 to $263,841 a year

Director roles in Massachusetts21 roles publishing pay

Middle half $200,000 to $238,000, median $227,500

Director roles in the US44 roles publishing pay

Middle half $191,750 to $242,750, median $213,750
Annual base pay
Annual base payLowMedianHigh
This role$203,157—$263,841
Massachusetts$200,000$227,500$238,000
All US$191,750$213,750$242,750

This role: Celldex Therapeutics's own published range. Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, October 20, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Regulatory CMC

The general path across 86 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not Celldex Therapeutics's own promotion track.

  1. Earlier

    Associate & Specialist

    Often: Associate CMC Regulatory Sciences Data Analyst · Assoc CMC Product Quality Compliance Specialist

    $77K median6 open

  2. Earlier

    Senior & Principal

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

    $155K median8 open

  3. One step back

    Manager

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

    $157K median21 open

  4. This role

    Director

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

    $214K median46 open

  5. Next step

    VP & Executive

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

    5 open

Career resources on Regulatory CMC

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: 7 linesDocumentation and SOPs: 2 linesValidation and qualification: 1 lineRegulatory submissions: 10 linesQuality systems and risk: 4 linesCollaboration and leadership: 13 linesGMPDocumentationValidationSubmissionsQuality systemsTeamwork
  • Collaboration and leadership13
  • Regulatory submissions10
  • GMP and compliance7
  • Quality systems and risk4
  • Documentation and SOPs2
  • Validation and qualification1

Regulatory intelligence

The rules behind this role

Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.

From Regulatory News

Manufacturing and quality coverage for this profession

Company hiring pulse

Celldex Therapeutics on Regulatory Jobs

6
Open roles
6
Distinct roles
3
Locations

By discipline

  • Quality5 83%
  • Regulatory1 17%

By level

  • Director3 50%
  • Associate & Specialist2 33%
  • Senior & Principal1 17%
See all 6 Celldex Therapeutics roles

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Senior Director, Regulatory Science and CMC Development Strategy at Celldex Therapeutics

Applications close October 23. $203K–$264K a year, employer provided.

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