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Director Regulatory Operations Jobs (NOW HIRING)

Kardigan

Senior Director, Regulatory Operations

Princeton, NJ · On-site

$157K - $207K/yr

Senior Director, Regulatory Operations Department: Regulatory Reports To : SVP, Head of Regulatory Location: South San Francisco, CA (preferred) or Princeton, NJ - On site 4 days a week (Mon to Thurs ...

Codera

Director, Regulatory Affairs

San Diego, CA · Remote

Collaborate with vendors who support regulatory operations-related tasks * Assist with developing ... Direct experience in interactions with health authorities and performing country and region ...

Bausch + Lomb

Director, Regulatory Affairs

OR · On-site +1

$165K - $220K/yr

The Director partners cross-functionally with Clinical, Nonclinical, CMC, Quality, Safety, and Regulatory Operations to develop global regulatory strategies, lead health authority interactions ...

Dyne Therapeutics

Director, Regulatory CMC

Waltham, MA

$161K - $213K/yr

The Director serves as a key strategic partner to Manufacturing, Quality, Clinical Operations, Program Teams, and the broader Regulatory organization, providing expert regulatory guidance, risk ...

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$107.7K

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How much do director regulatory operations jobs pay per year?

As of Jun 22, 2026, the average yearly pay for director regulatory operations in the United States is $107,680.00, according to ZipRecruiter salary data. Most workers in this role earn between $75,500.00 and $135,500.00 per year, depending on experience, location, and employer.

What are the typical responsibilities and team dynamics for a Director Regulatory Operations?

As a Director Regulatory Operations, your primary responsibilities include overseeing the preparation and submission of regulatory documents, ensuring compliance with global standards, and leading process improvement initiatives. You will usually manage a team of regulatory professionals and collaborate closely with clinical, quality, and legal departments to align regulatory strategies with business goals. The role often involves managing multiple projects simultaneously, tracking submission timelines, and anticipating regulatory challenges. This is a fast-paced position offering leadership opportunities and the potential to advance to executive roles within regulatory affairs or related departments.

What are the key skills and qualifications needed to thrive in the Director Regulatory Operations position, and why are they important?

To excel as a Director Regulatory Operations, you need comprehensive knowledge of regulatory affairs, quality systems, and project management, usually supported by an advanced degree in life sciences or a related field. Familiarity with regulatory submission systems (such as eCTD), document management platforms, and certifications like RAC (Regulatory Affairs Certification) are commonly required. Outstanding organizational skills, strategic leadership, and the ability to communicate and negotiate effectively are essential soft skills. These competencies ensure efficient regulatory compliance, timely submissions, and effective coordination across cross-functional teams in a highly regulated environment.

What does a Director of Regulatory Operations do?

A Director of Regulatory Operations oversees the development, submission, and management of regulatory documents to ensure compliance with industry regulations. They lead regulatory teams, streamline processes, and collaborate with internal stakeholders to meet regulatory requirements efficiently. Their responsibilities often include managing electronic submissions, maintaining regulatory information systems, and staying updated on changing regulatory guidelines.

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Director Regulatory Operations jobs near you

Senior Director, Regulatory Operations

Kardigan

Princeton, NJ

$157K - $207K/yr

Other

Posted 13 days ago

Job description

Position Title: Senior Director, Regulatory Operations

Department: Regulatory

Reports To: SVP, Head of Regulatory

Location: South San Francisco, CA (preferred) or Princeton, NJ - On site 4 days a week (Mon to Thurs)

Job Overview

Kardigan is seeking an experienced Senior Director, Regulatory Operations. Reporting directly to the SVP of Regulatory, the Senior Director will oversee global Regulatory Operations across Kardigan's portfolio.

This role is responsible for end-to-end management of global regulatory submissions, ensuring timely and compliant publishing, electronic submission and archival. The Senior Director will partner closely with Regulatory and cross-functional team members to deliver high quality, inspection ready submissions aligned with corporate objectives. This role will ensure or establish best practices for Regulatory Operations.

 

Key Responsibilities

Regulatory Submission Planning, Strategy & Execution

  • Oversee all regulatory submission types (eg, IND, CTA, NDA, MAA, and amendments) across Kardigan's portfolio.
  • Manage planning, publishing, electronic submission, and archival of regulatory submissions.
  • Establish clear lines of communication with stakeholders to align regulatory plans that maximize efficiency and quality of regulatory submissions.

Regulatory Operations Leadership & Team Management

  • Build, mentor, and manage a high-performing Regulatory Operations team, including contractors and vendors, to achieve overall corporate objectives.
  • Manage external vendors, CROs, and consultants for performance and budget.
  • Set clear goals and expectations, supporting continuous improvement and accountability.
  • Support cross-functional employee on-boarding and training by providing technical support to stakeholders and project team members as needed.
  • Support Regulatory budgeting and forecasting activities, including review of expenditures for activities related to vendor contracts.

Systems, Tools & Process Optimization

  • Maintain and enhance regulatory systems and tools (RIM, publishing, document management, templates and relevant style guides).
  • Partner with IT/business teams on validation and upgrades.
  • Develop and implement SOPs and standardized processes, drive process optimization.

Compliance, Inspection Readiness & Governance

  • Ensure operational compliance with global regulations and internal policies.
  • Lead inspection readiness, training, and documentation oversight.
  • Monitor regulatory changes and assess their impact.

 Qualifications and Preferred Skills

  • Bachelor's degree in a scientific, life sciences, or related field required. Advanced degree (MS, PhD, PharmD) preferred.
  • 10+ years of relevant industry experience, with majority of experience in Regulatory Operations.
  • Demonstrated experience leading global regulatory submissions across multiple regions.
  • Experienced in building and leading teams and managing outsourced partners.
  • Strong experience with eCTD publishing, regulatory systems (e.g., RIM), and regulatory document management.
  • Experience driving regulatory operations transformation or system implementations.
  • Experience supporting late stage development and regulatory inspections preferred.
  • Deep understanding of global regulatory submission requirements and health authority expectations.
  • Strategic thinker with strong execution, problem solving, and change management skills.
  • Excellent communication, collaboration, and stakeholder management abilities.
  • Strong organizational and project management skills with high attention to detail.
  • Ability to operate effectively in fast paced, evolving environments while maintaining quality and compliance.

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