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Director Regulatory Operations Jobs (NOW HIRING)

Takeda

Director, Regulatory Site CMC

Boston, MA · On-site

$163K - $215K/yr

The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change ... Promote sustainable practices and scalability in site-level regulatory operations. Minimum ...

Hippocratic AI

Director, Regulatory

Menlo Park, CA · On-site

$176K - $233K/yr

Establish labelling operations frameworks for l delivery, ensuring responses are accurate, evidence ... Advise on the regulatory requirements to ensure platform's compliant handling of medical inquiries ...

Nurix

Director, Regulatory Affairs

Brisbane, CA · On-site

$180K - $238K/yr

Director, Regulatory Affairs (Strategy, Immunology and Inflammation) Nurix Therapeutics is a ... operational plans * Represent Regulatory Affairs on assigned cross-functional development teams.

Nurix

Director, Regulatory Affairs

Brisbane, CA · On-site

$180K - $238K/yr

Director, Regulatory Affairs (Strategy, Immunology and Inflammation) Nurix Therapeutics is a ... operational plans * Represent Regulatory Affairs on assigned cross-functional development teams.

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$34K

$107.7K

$179.5K

How much do director regulatory operations jobs pay per year?

As of Jul 13, 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 Business Development Director - Regulatory & Medical Writing

Senior Business Development Director - Regulatory & Medical Writing

Veristat

Charleston, WV • Remote

$130 - $190K/hr

Full-time

Medical, Retirement

Posted 24 days ago

Job description

Job Description:

Senior Business Development Director - Regulatory & Medical Writing

The Senior Business Development Director - Regulatory & Medical Writing is responsible for driving growth of Veristat's Regulatory Science and Medical Writing services across pharmaceutical, biotechnology, and life sciences clients. This role focuses on developing new business opportunities and expanding existing accounts by positioning high-value, consultative solutions including regulatory strategy, submission support, regulatory operations, and scientific/medical writing.

The individual will lead strategic sales efforts, identify client needs across the product development lifecycle, and partner cross-functionally to deliver tailored solutions that support regulatory approvals and clinical development success.

The Senior Business Development Director serves as the primary liaison between the client and Veristat for all sales-related activities, enhancing the Company's visibility, credibility, and market presence within regulatory and scientific services.

Internally, this role collaborates closely with Regulatory, Medical Writing, Clinical, Project Management, and Finance teams to ensure alignment of client needs with service delivery and to drive long-term strategic partnerships.

Make an Impact at Veristat!

Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.

  • 105+ approved therapies for marketing applications prepared by Veristat
  • 480+ oncology projects in the past 5 years
  • 350+ rare disease projects delivered in the past 5 years
  • Flexible, inclusive culture - 70% remote workforce, 66% women-led teams

Learn more about our core values here!

What we offer

  • The estimated hiring range for this role is $130 - $190k base salary plus applicable competitive commission plan. This hiring range is specific to the US and will vary for other regions based upon local market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data.
  • Benefits vary by location and may include:
    • Remote working
    • Flexible time off
    • Paid holidays
    • Medical insurance
    • Tuition reimbursement
    • Retirement plans

What we look for

  • Bachelor's Degree in a business, science, or related field.
  • Minimum of 8 to 10 years of experience selling services in a CRO / pharmaceutical / biotechnology / life sciences industry, with expert knowledge of the clinical research process and requirements.
  • Demonstrated experience selling regulatory affairs, regulatory consulting, or medical writing services strongly preferred.
  • Strong understanding of the drug development lifecycle and global regulatory pathways (FDA, EMA, and other regulatory agencies).
  • Proven success in selling complex, consultative service offerings to pharmaceutical and biotechnology clients.
  • Strong communication, interpersonal, and presentation skills to prepare and deliver high-quality capabilities and sales presentations.
  • Strong communication and interpersonal skills.
  • Experience with proposal development, contract negotiation and closing a contract.
  • Ability to learn quickly and assimilate the detail of project requirements. Ability to be flexible and easily multitask.
  • Strong computer skills, including good working knowledge of Microsoft Office suite (i.e., Outlook, Word, Excel, Powerpoint)
  • Prior Salesforce experience strongly preferred.

Preferred Qualifications

  • Experience supporting or selling services related to IND, NDA, BLA, or MAA submissions
  • Familiarity with regulatory operations, publishing, and eCTD submissions
  • Experience with medical writing deliverables, including clinical study reports (CSRs), protocols, investigator brochures (IBs), and CTD modules
  • Established network within Regulatory Affairs and Clinical Development organizations

Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.

#LI-RD1

Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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