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Director Regulatory Operations Jobs (NOW HIRING)

Codera LLC

Director, Regulatory Affairs

San Diego, CA · On-site

$185K - $230K/yr

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

Codera

Director, Regulatory Affairs

San Diego, CA · Remote

$185K - $230K/yr

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

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$34K

$107.7K

$179.5K

How much do director regulatory operations jobs pay per year?

As of Aug 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 does a director 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.

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.

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Director Regulatory Operations jobs near you
Infographic showing various Director Regulatory Operations job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 84% Full Time, 11% Part Time, 1% Temporary, 2% Contract, and 1% Nights. 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.

Associate Director / Director, Regulatory Affairs

Treeline Biosciences

Watertown, MA • On-site

$175K - $206K/yr

Full-time

Posted 16 days ago

Job description

Associate Director / Director, Regulatory Affairs
About the Role
We are seeking a highly skilled and experienced Associate Director / Director of Regulatory Affairs to join our growing clinical team. This hands-on position will be responsible for overseeing and managing global regulatory activities to ensure compliance with applicable laws, regulations, and guidelines. In this role, you will contribute to and help implement regulatory strategy, prepare and manage regulatory submissions, and help guide the company through complex regulatory landscapes. The successful candidate will have experience in, and enthusiasm for, working in a small, dynamic environment with broad responsibilities.
Key Responsibilities
  • Collaborate cross-functionally with internal teams, including Clinical, Clinical Operations, Quality Assurance, Pharmacovigilance, Clinical Pharmacology, Technical Operations, and Non-Clinical/Toxicology, to prepare, review, and submit high-quality regulatory submissions, including INDs, NDAs, BLAs, briefing books, orphan drug designation requests, pediatric plans, and other relevant applications, ensuring compliance with regulatory requirements and timelines.
  • Contribute to (Associate Director) or hold final accountability for (Director) regulatory documentation, ensuring adherence to FDA and other global health authority specifications and timelines, including submissions, correspondence, and approvals, and ensuring accurate and organized records.
  • Partner with Technical Operations to facilitate CMC gap analyses, regulatory impact assessments, and submissions.
  • Manage third-party vendor and partner performance and workload to support regulatory operations and regulatory publishing.
  • Provide project management support for regulatory and clinical projects, including defining project objectives, developing project plans, allocating resources, and monitoring progress to ensure timely completion.
  • Serve as a point of contact and maintain effective relationships with regulatory agencies such as the FDA and EMA, ensuring open and constructive communication.
  • Develop and implement standard operating procedures (SOPs), best practices, and quality control measures to ensure compliance with regulatory standards.
  • Utilize project management tools and methodologies to effectively plan, track, and report on regulatory project status, milestones, and risks.
  • Contribute to and help develop regulatory strategy plans that integrate regulatory interactions and milestones with clinical timelines.
  • Stay current on evolving regulatory requirements, guidelines, and industry trends to proactively identify potential risks, opportunities, and organizational impact.
  • Support management of regulatory budgets, resources, and timelines to optimize operational efficiency and meet business objectives.
Qualifications and Skills
  • Bachelor's degree in life sciences, pharmacy, or a related field; advanced degree (MS, PharmD, PhD, or equivalent) preferred.
  • Minimum of 8+ years of regulatory affairs experience within the biopharmaceutical industry; oncology experience strongly preferred.
  • Experience with global regulatory requirements and guidelines (including FDA, EMA, and ICH) across preclinical and clinical stages; working knowledge of drug laws, regulations, guidelines, and product lifecycle management.
  • Particular interest in candidates with EU and ex-US regulatory experience (e.g. CTAs, CTR/CTIS, MAAs, PIPs, SA)
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal teams, external partners, and regulatory authorities.
  • Experience supporting or managing regulatory inspections, audits, and interactions with regulatory agencies, including direct agency contact.
  • Experience contributing to or executing regulatory strategies for complex products or therapies, including regulatory interactions, submissions, filings, and approvals.
  • Excellent written and verbal communication skills, with the ability to translate complex regulatory concepts for diverse audiences.
  • Detail-oriented, with excellent organizational and project management skills, capable of managing multiple projects and priorities simultaneously in a fast-paced environment.

This position is classified as exempt. The anticipated annual base salary range for candidates who will work in Watertown is $175,000 to $206,015. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states.
Recruitment fraud statement
Please be aware of recruitment fraud and related job scams, where scammers present themselves as recruiters but are seeking to steal money or personal information. Keep the following in mind to protect yourself:
  • Treeline Biosciences will never ask for money from you as part of our recruitment process. Do not provide bank details or pay somebody for the promise of a job at Treeline.
  • We do not conduct interviews through Skype or Telegram.
  • Our job openings are first posted to treeline.bio/careers. If you locate a listing for a Treeline job on another site, please ensure it is also posted on our careers website.
  • You can find more information about job scams at consumer.ftc.gov/articles/job-scams.
  • To report job scams, head to ReportFraud.ftc.gov.

Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters)
The Human Resources team manages the recruitment and employment process for Treeline Biosciences. To protect the interests of all parties involved, Treeline Biosciences will only accept resumes from a recruiter if an executed search agreement directed to the particular position or positions is in place at the start of the recruitment effort. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.

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