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Senior Director Regulatory Operations Jobs (NOW HIRING)

McKesson

Sr. Director, Regulatory Affairs

Richmond, VA · Hybrid

$148K - $195K/yr

The Sr. Director of Regulatory Affairs leads the development and execution of regulatory strategies ... This role is accountable for aligning business operations with applicable regulatory requirements ...

McKesson

Sr. Director, Regulatory Affairs

Richmond, VA · Hybrid

$148K - $195K/yr

The Sr. Director of Regulatory Affairs leads the development and execution of regulatory strategies ... This role is accountable for aligning business operations with applicable regulatory requirements ...

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Senior Director Regulatory Operations information

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$34K

$107.7K

$179.5K

How much do senior director regulatory operations jobs pay per year?

As of Aug 10, 2026, the average yearly pay for senior 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 challenges faced by a senior director regulatory operations when overseeing global submissions?

A Senior Director of Regulatory Operations often encounters challenges such as coordinating submissions across multiple regions with varying regulatory requirements, managing tight timelines, and ensuring data consistency. The role requires strong cross-functional collaboration with clinical, legal, and CMC teams to gather and validate information. Proactively addressing evolving regulatory guidelines and leveraging technology for document management are also key to success in this position.

What are the key skills and qualifications needed to thrive as a senior director regulatory operations?

To excel as a Senior Director Regulatory Operations, you need extensive experience in regulatory affairs, strong leadership abilities, and an advanced degree in life sciences or a related field. Familiarity with regulatory submission platforms (such as eCTD), document management systems, and relevant certifications like RAC are commonly required. Outstanding communication, strategic thinking, and cross-functional collaboration skills set top candidates apart. These competencies ensure efficient regulatory submissions, compliance with global standards, and effective team leadership in a complex regulatory environment.

What is a senior director regulatory operations?

A Senior Director of Regulatory Operations is a high-level executive responsible for overseeing and managing the regulatory submission process within a company, typically in the pharmaceutical, biotechnology, or medical device industries. They lead teams that prepare and submit documentation to regulatory agencies, ensuring compliance with global regulations and standards. Their role also involves developing strategies for regulatory submissions, maintaining timelines, and liaising with internal and external stakeholders to facilitate product approvals and compliance. This position requires extensive experience in regulatory affairs, strong leadership skills, and up-to-date knowledge of industry regulations.

What is the difference between Senior Director Regulatory Operations vs Regulatory Affairs Manager?

AspectSenior Director Regulatory OperationsRegulatory Affairs Manager
CredentialsAdvanced degree (e.g., MS, PhD), extensive regulatory experienceBachelor's or Master's degree, relevant regulatory experience
Work EnvironmentStrategic leadership, cross-departmental oversightOperational execution, project management
Industry UsageUsed in large pharmaceutical or biotech companiesCommon in mid-sized to large organizations
Search/Comparison IntentUnderstanding senior leadership roles in regulatoryOperational regulatory roles and responsibilities

The Senior Director Regulatory Operations focuses on strategic leadership, overseeing regulatory processes across departments, and ensuring compliance at a high level. In contrast, the Regulatory Affairs Manager handles day-to-day regulatory activities, manages submissions, and supports compliance efforts. Both roles require regulatory knowledge, but differ in scope, seniority, and focus within the organization.

More about Senior Director Regulatory Operations jobs
What cities are hiring for Senior Director Regulatory Operations jobs? Cities with the most Senior Director Regulatory Operations job openings:
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What job categories do people searching Senior Director Regulatory Operations jobs look for? The top searched job categories for Senior Director Regulatory Operations jobs are:
Senior Director Regulatory Operations jobs near you
Infographic showing various Senior Director Regulatory Operations job openings in the United States as of August 2026, with employment types broken down into 85% Full Time, 12% Part Time, 1% Temporary, and 2% Contract. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $107,680 per year, or $51.8 per hour.

Senior Director, Regulatory Affairs

823 ICON Clinical (UK) Limited

Blue Bell, PA • On-site

$143K - $189K/yr

Full-time

Posted 24 days ago

Job description

Senior Director, Regulatory Affairs

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.


As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.


As a Senior Director, Regulatory Affairs at ICON, you will provide strategic direction and management of Regulatory Affairs teams (up to 80 team members) and projects and contribute to the strategic direction and overall management of the Regulatory Affairs function at ICON strategic solutions.

What You Will Do:

Your focus will be on driving regulatory affairs performance, ensuring quality, and building capability across your area.
Key responsibilities include:

  • Lead and oversee the regulatory affairs strategy for ICON's therapeutic area teams as a departmental leader, set a clear and convincing future direction, while communicating with clarity.
  • Collaborate with cross-functional teams to develop comprehensive regulatory plans and submissions
  • Provide expert guidance on regulatory requirements and ensure adherence to global regulations
  • Prepare and/or support proposals and bids and attend client bid defense meetings; participate in Triage meetings as required
  • Represent ICON in interactions with regulatory authorities, presenting data and addressing inquiries
  • Mentor and develop a team of regulatory affairs professionals, fostering their growth and expertise
  • Represent the Regulatory Affairs Department in Business Development activities and generate new business opportunities.
  • Energizing & Developing Others: Creating an environment that motivates people; Identifies development opportunities for self and others; act as a coach and mentor and share expertise.
  • Commercial Awareness: Understanding the ICON business globally; Controls costs and maximizes revenues, margins and added value; Promotes ICON effectively in all interactions.

Your Profile:

You will bring significant regulatory affairs experience, with a track record of building high-performing teams and delivering results.
Required qualifications and experience:

  • Bachelor's degree in a relevant scientific discipline or healthcare-related field; advanced degree preferred
  • Extensive experience in regulatory affairs, with a proven track record in leading global submissions
  • In-depth knowledge of regulatory guidelines, ICH/GCP, and industry best practices
  • Strong analytical and problem-solving skills, with the ability to navigate complex regulatory landscapes
  • Excellent communication and negotiation abilities, with the capacity to convey regulatory strategies effectively
  • Willingness to travel as required (approximately 25%)

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.


Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.


Benefits may include:

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.


Visit our careers site to read more about the benefits ICON offers.


Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.


If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply